Agenda 249th Registration Board Meeting

Agenda for 249th Meeting Registration Board to be held on 18-19th May, 2015.
Item No.
Detail of Item
Item No.I
Confirmation of minutes of 248th meeting Registration Board
Item No.II
Cases referred by Pharmacy Services Division
Item No.III
Cases referred by Pharmaceutical Evaluation & Registration Division
Item No.IV
Cases referred by Biological Evaluation & Research Division
Item No.V
Cases referred by Quality Assurance & Lab Testing Division

Any other item with permission of Chair
Item No. I: Confirmation of minutes of 248th meeting Registration Board.

248th meeting of Registration Board was held on 18-19 thMarch, 2015 and minutes were
circulated to all members through e-mail. None of the member forwarded comments and thus
minutes were approved by the Chairman.
Submitted for consideration of Registration Board.
Item No. II: Cases referred by Pharmacy Services Division.
Case No.01 Draft National Action Plan for combating the Antimicrobial Resistance and
establishment and strengthening of National and Provincial Pharmacovigilance Center.
Antimicrobial resistance is resistance of a microorganism to an antimicrobial drug that

was originally effective for treatment of infections caused by it. Resistant microorganisms
(including bacteria, fungi, viruses and parasites) are able to withstand attack by antimicrobial
drugs, such as antibacterial drugs (e.g. antibiotics), antifungals, antivirals, and antimalarials,
so that standard treatments become ineffective and infections persist, increasing the risk of
spread to others.
The main driver of Antimicrobial Resistance (AMR) is the misuse and over use of
Antimicrobial Drrugs. Poor infection control practices, inadequate sanitary conditions and
inappropriate food-handling encourage the further spread of antimicrobial resistance.
New resistance mechanisms emerge and spread globally threatening our ability to treat
common infectious diseases, resulting in death and disability of individuals who until recently
could continue a normal course of life. Without effective anti-infective treatment, many
standard medical treatments will fail or turn into very high risk procedures.
Infections caused by resistant microorganisms often fail to respond to the standard

treatment, resulting in prolonged illness, higher health care expenditures, and a greater risk of
2
death. As an example, the death rate for patients with serious infections caused by common
bacteria treated in hospitals can be about twice that of patients with infections caused by the
same
non-resistant
bacteria.
For
example,
people
with
MRSA
(methicillin-
resistant Staphylococcus aureus, another common source of severe infections in the

community and in hospitals) are estimated to be 64% more likely to die than people with a
non-resistant form of the infection.
Antimicrobial resistance is a major concern to the public health, threatening the

progress made in treatment of infectious diseases as well as advances in modern medicine. The
use of antimicrobial is strongly linked to the development of antimicrobial resistance. It is
therefore of great importance to find ways to assure responsible use, balancing between
minimizing unnecessary use without compromising the health needs of the individual. The use of
antimicrobial in food production & agriculture has further aggravated the problem.
Pakistan is the sixth heavily populated country in the world comprising over 180 million
population. Life expectancy rate for male is 65 and for female is 66 years. There is an urgent
need for multisectoral collaboration based on One Health Approach to combat the antibacterial
resistance.
The same issue has also been agitated in Senate of Pakistan to be taken as priority where
a commitment has been submitted by the DRAP to develop a national plan covering all the
aspects to address the issue. Accordingly, a National Action plan has been prepared and
submitted before the Board for consideration:Objective 1: Improve awareness and understanding of Antimicrobial Resistance
through effective communication, education and training
Steps need to be taken immediately in order to raise awareness of antimicrobial
resistance and promote behavioral change, through public communication programmes that
target different audiences in human health and animal practice as well as consumers;
Inclusion of the use of antimicrobial agents and resistance in medicine and pharmacy
curricula will promote better understanding and awareness from an early age.
Making antimicrobial resistance a core component of professional education,

training, certification and development in the health and veterinary sectors practice will help
to ensure proper understanding and awareness among professionals.
Objective 2: Strengthen the knowledge and evidence base through surveillance and
research.
Actions and investments to tackle antimicrobial resistance will be supported by clear
rationales of their benefit and cost-effectiveness. National governments, intergovernmental
organizations, agencies, professional organizations, nongovernmental organizations, industry
and academia have important roles in generating such knowledge and translating it into
practice.
Particularly important gaps in knowledge that need to be filled include the following:
The incidence, prevalence, range across pathogens and geographical; patterns

related to antimicrobial resistance are all information that is needed to guide
the treatment of patients: to inform local, national and provincial actions; and
to monitor the effectiveness of interventions.
Understanding of how resistance develops and spreads, including how
resistance circulates within and between humans and animals and through
food water and the environment, is important for the development of new
tools, policies and regulations to counter antimicrobial resistance.
The ability rapidly to characterize newly emerged resistance in
microorganisms and elucidate the underlying mechanisms; this knowledge is
necessary to ensure that surveillance and diagnostic tools and methods remain
current.
Understanding of the social science and behavior needed to support and
achievement of Objective-1.
Research into, including clinical trails of, treatments for common bacterial
infections, especially in low-resource settings.
Basic research and translational studies to support the development of new
treatments, diagnostics, vaccines and other interventions.
Economic research, including the development of models to assess the cost of
antimicrobial resistance and the costs and benefits of this action plan.
Objective 3: Reduce the incidence of infection through effective sanitation, hygiene and
infection prevention measures.
Many of the most serious and difficult-to-treat antibiotic-resistant infections occur in
healthcare facilities, not only because that is where patients with serious infections are
admitted but also because of the intensive use therein of antibiotics and inadequate measures
to prevent and control infection.
Better hygienic and infection prevention measures are essential to limit the
development and spread of antimicrobial-resistant infections and multidrug-resistant
bacteria. Effective prevention of infections transmitted through sex or drug injection as well
as better sanitation, hand washing, and food and water safety must also be core components
of infectious disease prevention. Malaria has the greatest public health impact of all vectorborne infectious diseases and is the most affected by antimicrobial resistance; vector control
holds the key to malaria prevention, control and elimination.
Immunization can reduce antimicrobial resistance in three ways.
Existing vaccines can prevent infectious diseases whose treatment would require
antimicrobial medicines.
Existing vaccines can reduce the prevalence of viral infections, which are often
inappropriately treated with antibiotics.
Use of new or improved vaccines can prevent diseases that are becoming difficult
to treat or are untreatable owing to antimicrobial resistance.
Objective 4 : Optimize the use of antimicrobial medicines in human and animal

health.
Evidence that antimicrobial resistance is driven by the volume of use of antimicrobial
agents is compelling. High antibiotic use may reflect over-prescription, easy through overthe-counter sales and, more recently, via the Internet, which are widespread in many
countries. Despite measures taken by some Provinces, antibiotic use in humans, animals and
agriculture is still increasing. The projected increase in demand for animal food products
may lead to yet further increases in antibiotic use.
Data on antibiotics use are collected and analyzed in many high- and middle-income
countries. However, data are lacking on antibiotic use in human beings at the point of care
and at federal and provincial level.
More widespread recognition of antimicrobial medicines as a public good is needed
in order to strengthen regulation of their distribution, quality and use, and encourage
investment in research and development. Industrys spending on promoting products is
greater than governmental investment in promoting rational use of antimicrobial medicines
or providing objective information.
Decisions to prescribe antibiotics are rarely based on definitive diagnosis effective,
rapid, low-cost diagnostic tools are needed for guiding optimal use of antibiotics in human
and animal medicine, and such tools should be easily integrated into clinical, pharmacy and
veterinary practices. Evidence-based prescribing and dispensing should be of the standard of
care.
Regulation of the use of antimicrobial agents is inadequate or poorly enforced in
many provinces, such as over-the-counter and Internet sales. Related weaknesses that
contribute to development of antimicrobial resistance include poor patient compliance, the
prevalence of substandard medicines for both human and veterinary use.
Objective 5: Develop the economic case for sustainable investment that takes account of
the needs of all provinces, and increase investment in new medicines, diagnostic tools,
vaccines and other interventions.
The economic case must reflect the need for capacity development, including training
in low-resource settings, and the need for new and accessible interventions, including
medicines, diagnostics and vaccines.
Economic impact assessments are needed on the health and broader socioeconomic
burden of antimicrobial resistance, and should compare the cost of doing nothing against the
cost and benefit of action. Lack of such data hindered implementation of the 2001 Global
Strategy for Containment of Antimicrobial Resistance. The few studies on the economic cost
of antimicrobial resistance are limited chiefly to developed countries.
Data on antibiotic use will be collected and analyzed in Provinces to develop a

database in antibiotic use in animals. However, data are lacking on antibiotic use in human
being at the point of care and from Provinces.
More widespread recognition of antimicrobial medicines as a public good is needed
in order to strengthen regulation of their distribution, quality and use, and encourage
investment in research and development. In some cases, industrys spending on promoting
products is greater than governmental investment in promoting rational use of antimicrobial
medicines or providing objective information.
Decisions to prescribe antibiotics are rarely based on definitive diagnosis effective,
rapid low-cost diagnostic tools are needed for guiding optimal use of antibiotics in human
and animal medicine, and such tools should be easily integrated into clinical, pharmacy and
veterinary practices. Evidence based prescribing and dispensing should be the standard of
care.
Regulation of the use of antimicrobial agents is inadequate or poorly enforced in
many areas. Such as over-the-counter, internet sales and inappropriate practices. Related
weaknesses that contribute to development of antimicrobial resistance include poor patient
compliance, the prevalence of substandard medicines for both human and veterinary use,
Federal Government is committed to provide safe, effective and quality medicine
at reasonable price with rational use to meet the Millennium Development Goals (MDGs) set
forth.
If approved by the Registration Board, the action plan may be submitted to the Policy
Board for further deliberation and necessary action and as well as for the development &
strengthening of Pharmacovigilance Centers at federal & provincial settings.
Submitted for consideration of Registration Board
Case No.02: Polio End-Game Strategies-Poliovirus Type 2 challenge study. A Five Arm
Community Based Randomized Trial, Karachi. Pakistan.
The subject trial was applied by Dr. Ali Faisal Saleem, Dept. of Pediatrics & Child
Health, Aga Khan University (Principle Investigator), which the has been discussed in the M247th meeting of Registration Board. The key feature of the trial is as under:
Title
Polio End-game strategies-Poliovirus Type 2 challenge study. A Five Arm

Community Based Randomized Trial, Karachi. Pakistan.
III
Polio disease is present in only three countries including Pakistan. Since the
injectable polio vaccine has better results, WHO Polio Endgame Strategy
is to slowly withdraw the current vaccines replace all oral polio vaccine with
injectable polio vaccine.
The over all purpose of this study is to compare the suggested five different
polio vaccine strategies to see which produces the best immunity for Pakistani
Children and prevents the spread of polio.
Phase
Background
Objective
Participating
Country/Sites.
Pakistan
Outreach Primary clinics in Karachi at Rehri Goth, Ali Akber Shah Goth,
Ibrahim Hyderi and Bhains Colony.
of 1000 children each study group (arm) will have 200 children.
Number
participants
Duration
of One year (June 2014-15)
Trial.
Study
Oral Bivalent vaccine Available from EPI
Interventions.
Oral Trivalent Vaccine Available from EPI
Inactivated Polio Vaccine (IPV) To be imported
Inactivated Polio Vaccine2 (IPV2) To be imported
Oral Monovalent Vaccine2 (mOPV2) To be imported at a later stage
in the study. An amendment and request will be sent to DRA at that
time.
Study
To determine which vaccine best protects the children from polio
Outcomes
Quantity
of
IPV= 1510 Doses
Drug to be
IPV= 230 Doses
Imported.
Other vaccines are already registered and standard of care. These will
be purchased from EPI.
Registration
Oral Bivalent, trivalent polio vaccine is provided to EPI by WHO.
Status of drugs
in Pakistan.
Monitor of the
Dr. Maha Mohamed Saadeldine Salama
Trial.
Head Clinical Research Sector/VACSERA, CairoEgypt.
8
Sponsor
World Health Organization (Geneva)
An expert opinion from the following three experts was already taken and presented before the
Board to facilitate the decision-making procedure of Board.
S.No
.
1.
2.
3.
Expert Name
Opinion
Syed Sohail Zahoor

Zaidi, Chief Scientist
(Virology) Head of
Department of Virology
It is hereby informed that the subject study is well planned to

determine the improved effect of vaccination with combined
formulations i.e bivalent OPV + IPV vaccines to fill-in the
gaps in immunity type 2 polioviruses among Pakistani
Children.
The study will be conducted with the financial and technical
support of WHO Head Quarters, Geneva and does not pose
any apparent burden on the GoP/National or international stake
holders providing assistance for the Polio Eradication program
in the country.
I hope that the findings and outcomes of this interventional
study will improve our understandingand help to devise
progressive recommendations for vaccination to achieve the
goal of Polio eradication.
Mr.Mazharullah
The five arms plan for End Game Polio Virus, the pattern of
Memon,
Principal dosing as described are suitable for the subject study and the
Scientific
subject clinical trial is suggested in my opinion and there is no
Officer/Manager
financial burden on the Government of Pakistan.
Quality
Control
Laboratory.
Dr. Haider Sherazi, The expert has recommended the clinical trial.
Neonatology,
PIMS,
Islamabad.
Wherein, the Board in its M-247th meeting after thorough deliberation on the study decided as
under:
"Principal Investigator (PI) Dr. Ali Faisal, Assistant Prof and Dr. Tahir
Yousaf zai, Senior Instructor both from Aga Khan University appeared before the Board
to
deliberate
upon
the
trial
(which
is
specific
to
Pakistan
only).
Registration Board gained knowledge from the presentation given by the above
representatives that they intend to partially amend the trial by adding additional
comparison through mOPV to already indicated IPV and IPV2. Moreover, there is a need
to submit the details of published and unpublished data related to the trial. Further, the
regulatory approval (alongwith summary protocol) of the IPV2 in the country of origin is
required by the applicant.
9
Registration Board appreciated the presentation and recommended that the trial
under present condition is currently premature unless we have the secondary opinion from
additional expert namely Prof. Dr. Tariq Bhutta and also opinion from WHO regarding
the current status of the instant trial at other clinical trial centers in the world, (if any).
Additionally, the Principal Investigator (PI) / Applicant be advised to make arrangement
for extending the sero-testing and virology with NIH as a secondary arrangement.
Registration Board agreed to the conduct of trial. However, outcome of the expert
opinions will be presented in the forthcoming meeting of the Board for final decision.
In pursuance of above Registration Board decision, the additional expert opinion on the trial was
south from Dr. Tariq Bhutta and also opinion from WHO regarding the current status of the
instant trial at other clinical trial centers in the world, (if any). Now, the Dr. Tariq Bhutta has
replied and sent his opinion through an e-mail which is reproduced as under:
Tariq Bhutta <tbhutta240@gmail.com>
Sat, Apr 4, 2015 at 1:08 PM
To: "babarkhanabuhamza@gmail.com" <babarkhanabuhamza@gmail.com>
Dear Mr Babar
Sorry for a delayed reply to your letter regarding the aboved mentioned subject. Dr Ali
Saleems proposal about assessing the protection of type2 polio virus after using bivalent
OPV and IPV and comparing it with protection afforded by tOPV only.
He also plan to quantify the cross reactivity of bOPV on inducing type 2 immunological
reaction. The type2 wild polio virus has been eradicated globally in 1999. But the vaccine
derived polio virus crops up in those areas where the routine coverage of polio immunisation
is poor. This has happened in Baluchistan as well as Waziristan in the last few years.
This is the reason that WHO is planning to introduce one dose of IPV in the EPI program
from June this year to provide protection against all three wild types of polio virus without
risk of VAPP as well as CVDPV.
In view of these challenges the research proposal by Dr Ali Saleem looks interesting and will
provide evidence of using only bivalent OPV and withdrawing tOPV. I would recommend
that he may be allowed to import trial vaccines as required particularly mOPV2 and IPV2
and. IPV.
The opinion from WHO is still awaited. A reminder has already been issued.
10
Regarding Board advice for extension in sero-testing and virology in NIH, the applicant has submitted its
response through an e-mail as:
Dear Ali,
We are committed to test the stool samples at Virology, NIH.The NIH sero-testing facility is
under development.
Kind Regards
Sohail Zaidi
Prima Facie this is the case of grant of approval of clinical trial permission to be conducted as per
protocol approved by WHO at Aga Khan Medical University. Three expert opinions were already in
favour of the conduct of the trial permission. However, an additional opinion on the direction of the Board
has also been sought & the same is also in favour of the trial.
The case is submitted for consideration so as to grant the permission if considered appropriate in the
public interest by the Board.
11
Case No. 03: Recombinant Bovine Growth Hormone (rBGH or rBST)

A writ petition No. 10663/2015 filled by the Sarfraz Ahmed s/o Nazir Ahmed Vs State & writ
petition N 0. 11803/2015 filled by Ghazanfar Abbas & Saqlain Abbas Vs State are already under
submission with the Honorable Court. This is based on appearance of a Fact Sheet comes on the
surface of the internet regarding Recombinant Bovine Growth Hormone (rBGH or rBST)
developed by Rick North, Oregon Physicians for Social Responsibility, November 2010which is
reproduced as under:
The FDA approved the use of recombinant bovine growth hormone (rBGH or rBST) in dairy
cows in 1993. This was done over the widespread objections of farmers, public health advocates
and animal welfare agencies. This genetically engineered hormone was developed by Monsanto
and sold to Elanco, a division of the Eli Lilly drug company, in 2008. Its trade name is Posilac.
There is overwhelming documented evidence that rBGH increases the rates of physical harm to
cows.
This paper summarizes the case against the use of rBGH on animal welfare grounds and
reinforces the call to disallow it.
FDA Posilac Package Insert
Although the FDA allowed rBGH to be commercialized, it acknowledged that it increased the
rates of 16 harmful physical effects on cows and required an insert, listing the following
conditions, be placed in every package sold. These include:
Reproductive Effects: Reduced pregnancy rates, increase in days open, increased
incidence of retained placenta, decreased gestation length and birth weight of calves
Increased rate of clinical mastitis and Increased rate of subclinical mastitis (somatic
cell count)
Increased body temperature unrelated to illness (heat stress)
Increase in digestive disorders, such as indigestion, bloat and diarrhea
Increase in reduced feed intake (off-feed)
Increased numbers of enlarged hocks and lesions and increased numbers of foot
disorders
Increased number of injection site reactions swelling
Reductions in hemoglobin and hematocrit values
FDA Adverse Drug Reaction Reports
12
After rBGH was approved, farmers submitted reports to the FDA describing harm the drug had
caused to their cows. These included all of the above, plus others, such as abortions, birth
defects, increased twinning rates and lameness.
These harmful effects are widespread. From 1994 to 2005, the FDA received 2,408 adverse drug
reaction reports from farmers that described harmful effects to cows injected with rBGH.
(Freedom of Information Act documents received from FDA, Sept. 2010) There are currently
about 65,000 dairy farmers in the U.S.
USDA Reports:
The USDA periodically issues reports on the state of American agriculture, including dairy. Their
Dairy 2002 Report was clear on rBGH:
Dairy producers have expressed concerns about (r)bST use. These concerns include:
animalhealth . . . and public health concerns . . . Dairy producers that were not currently
using bST were asked to describe their reason for not implementing a bST program . . . cost
and animal health were major concerns specifically identified in all regions . . .
Academic Studies:
Henry An and Leslie Butler have done several studies on why farmers started and later
disadopted use of rBGH. Their 1997-98 study found Many (farmers) . . . had problems like
mastitis, lameness, loss of condition, and lowered immune system functions which they
attributed to rbST use. Their 2008 report on disadoption rates in California found that 15% of
farmers cited high veterinary costs as very important in their decision to stop using rBGH.
(Henry An and Leslie Butler, Update on rBST Use in the California Dairy Industry, Giannini
Foundation
of
Agricultural
Economics
University
of
California,
2008)
Canada and European Union Bans on rBGH Use:

Although scientists in Canada and the European Union expressed human health concerns about
rBGH, specifically cancer and antibiotic resistance, the official reason that both banned rBGH
was harm to cows.
The Canadian Veterinary Medical Association Expert Panel of rbST determined that mastitis
increasedby 25%, infertility by 18%, lameness by 50% and culling (slaughter) by 20-25%.
(Report of Canadian Veterinary Medical Association Expert Panel on rbST. Prepared for Health
Canada, November, 1998. At:
13
http://www.hc-sc.gc.ca/dhp-mps/vet/issues-enjeux/rbst-stbr/rep_cvma-rap_acdv_tc-tm-eng.php).
Health Canada announced in January 1999 that it had to reject the request for approval to
use rbST in Canada, as it presents a sufficient and unacceptable threat to the safety of
dairy cows. (Institute of Food Science and Technology Information Statement on Bovine
Somatotropin. 2004, p. 5 at:
www.ifst.org/document.aspx?id=113)
A scientific committee in the EU found rBGH use led to painful and debilitating conditions
in cows and Therefore from the point of view of animal welfare, including health, the
Scientific /Committee on Animal Health and Animal Welfare is of the opinion that (r)BST
should not be used in dairy cows.
(Report on Animal Welfare Aspects of Use of Recombinant Bovine Somatotropin. Report of the
Scientific Committee on Animal Health and Animal Welfare. March 10, 1999. At:
http://ec.europa.eu/food/fs/sc/scah/out21_en.pdf)
Organizational Stances:
Virtually every major animal welfare organization in the U.S. opposes rBGH. This includes the
Humane Society of the U.S. (HSUS), Humane Farming Association and Farm Sanctuary.
According to Miyun Park, former Vice President of Farm Animal Welfare of HSUS, Its
simply wrong to inject cows with a substance like rBGH that increases painful and
debilitating diseases like mastitis and lameness.
(Know Your Milk, Oregon Physicians for Social Responsibility, 2010)
Both the National Family Farm Coalition and Family Farm Defenders oppose rBGH. John
Kinsman, president of the Family Farm Defenders, stated The FDAs approval . . . did not
even consider the demonstrated health impacts on dairy cows or the potential risks to
human consumers.
Voices of the Farmers Themselves A small sample:
Tillamook dairy farmer Dick Heathershaw . . . quit using the product (rBGH) after noticing
cows were splitting out in the pelvic area, were growing hooves at an accelerated rate and
were experiencing unusually high levels of abscesses . . . we thought we were seeing things
in our cows health-wisethat we didnt like and that we hadnt seen before. (Capital Press,
Feb. 25, 2005)
Its like steroids for athletes, said Stephen H. Taylor, New Hampshires Commissioner
of Agriculture, Markets and Food and a dairy farmer himself. He said he had tried the
14
hormone but it put stress on his cows and made them thinner. (New York Times, Oct. 7,
2006)
. . . most Country Classic farmers werent keen on growth hormone because of the
potential harmto their stock. The word among farmers was that growth hormone boosted
milk production in the short term but shortened the cow s productive life. (Billings, MT
Gazette, Sept. 13, 2008)
The case is being submitted and brought to the notice of the Registration Board as per
requirement of rule 30 (10) (a) of Drugs (Licensing, Registering and Advertising) Rules, 1976
for any further necessary advice and future course of action.
15
Item No.III
Pharmaceutical Evaluation & Registration Division.
Case No.01: Reference regulatory authorities and countries for grant of registration
Registration board grants registration of drugs if a drug is registered in any of the
regulatory authorities namely US FDA, EMA, TGA Australia, Health Canada and PMDA Japan.
It has been emphasized by stakeholders that this criterion should be broadened and other
countries be also included in this list to make more therapies available to patients in the country.
Therefore, in addition to above regulatory authorities other developed countries with stringent
drug regulatory systems may also be considered for registration of drugs in the country:
Submitted for consideration of board
Case No.02: Segregated facility for psychotropic drugs
Central Licensing Board in its 233rd meeting while discussing the manufacturing
requirements for psychotrpic drugs, decided as follows:
After thorough deliberations and keeping in view the directions of Policy Board,
recommendations of DRAP Authority, recommendations of Committee for Allocation of
Controlled Substances / Drugs (Inter-Ministerial Committee), views of honorable members,
previous decisions of Central Licensing Board on the said issue, and ensuring adequate
availability of narcotic drugs and psychotropic substances for medical and scientific purposes as
highlighted by INCB, the Central Licensing Board decided: To continue the previous policy / decisions of Central Licensing Board of segregated
facility for manufacturing of Psychotropic / Narcotic Drugs.
To process all pending layout plans / applications accordingly in the light of above
decision.
To carryout fresh panel inspections of sections / areas of Psychotropic / Narcotic Drugs
considered and deferred in 227th meeting of CLB.
Guidance of Registration Board is solicited for the manfacturers possessing psychotropic
registrations in general manufacturing area/ sections.
16
Case No.03: Guidelines on stability studies

Registration Board took following decision in 248th meeting regarding stability data required for
registration of drugs:
a. Manufacturers shall submit laboratory scale scientifically rational stability data for their
registration applications (new/me too) for consideration of the Board. Grant of registration will
be subject to commitment of manufacturer for performing and approval of stability testing as per
ICH / WHO guidelines as applicable before sale of drug.
b. All appliacnts who have been previously advised to provide stability studies as per ICH/WHO
guidelines will be again advised to submit laboratory scale scientifically rational stability data
for further consideration by Registration Board.
In vew of above, following proposal/ guideline has been submitted by PPMA for conducting
stability studies in Pakistan.
Purpose:
The purpose of this procedure is to provide guidelines and instruction for both accelerated
stability and long term stability studies of finished products.
Procedure:
Finished Products should be tested at designated testing frequency for certain chemical, physical,
biological and microbiologicalproperties (where applicable) as per specifications and label claim to
confirm the stability of the product within the proposed shelf life.
The stability study of the finished product should be in the same formulation, same specifications
and same container closure system (packing especially primary packing) as proposed for
marketing.
Storage conditions:
The studies should be carried out at following storage conditions:
a. Intended to be stored at temperature below 30 C
Accelerated stability (40C + 2C and 75% + 5% RH)
Long Term stability (30C 2C and 65 % 5 % RH)
b. Intended to be stored in Refrigerator
Accelerated stability (25C + 2C and 60% + 5% RH)
17
Long Term stability (5C 3 C)

c. Intended to be stored in freezer
Accelerated stability (5C + 3C)
Long Term stability (-20C 5 C)
Duration and frequency of testing:
The duration of accelerated stability should be 6 months and frequency of testing should be
0,1,3 and 6 months.
The duration of long term stability should be 24 months and frequency of testing should be
0, 3, 6, 9, 12, 18, 24 months.
Selection of batches for stability studies:
Stability studies should be performed on the following:
One Lab scale batch.

Two Pilot batches.
Lab scale trial batch:

The sample quantity should be determined on the basis of testing method / specification and
intervals. Sufficient quantity for one testing multiplied by number of testing gives the total
quantity for complete study; quantities required, on this basis, are appended below:
04
Frequency of tests 0, 1, 3 =
&6
=
Retest(s) if required
Total tests
05
S.
No.
Dosage Form
1.
Tablet / Capsule
2.
Dry Suspensions / Sachets (Oral)
01
Qty. Per Test
Total Quantity
Required
40 Nos.
40 x 5 = 200 Nos.
Suspensions
05 Bottles
5 x 5 = 25 Bottles
Sachets
05 Sachets
5 x 5 = 25 Sachets
18
3.
Dry Powder Injections
4.
Semi Solids
5.
5 x 5 = 25 Vials
02 Tubes
2 x 5 = 10 Tubes
02 Bottles
2 x 5 = 10 Bottles
Liquid (Oral)
6.
Cream / Ointment / Gel
05 Vials
Liquid Syrup / Suspension
Sterile Liquids
Infusion
02 Vials
2 x 5 = 10 Vials
Injection
05 Amps. / Vials
5 x 5 = 25 Amps. /Vials
Eye Drops
02 Packs
2 x 5 = 10 Packs
Biological Products
7.
A.
Pre-Filled Syringe (PFS)
05 PFS
5 x 5 = 25 PFS
Liquid vials
05 Vials
5 x 5 = 25 Vials
Lyophilized vials
05 Vials
5 x 5 = 25 Vials
Ampoules
05 Ampoules
5 x 5 = 25 Ampoules
Pilot Batch (10% of Commercial Batch)
Frequency of tests (Accelerated) 0, 1,

3&6
(Long term) 0, 3,
6, 9, 12, 18, 24
04
06
Retest(s) if required
02
Total tests
12
Quantity Required
S.
No.
Dosage Form
1.
Tablet / Capsule
2.
Dry Suspensions / Sachets

(Oral)
Qty. Per
Test
40 Nos.
For Tests
For
Validation
(A)
(B)
40 x 12 =
480
40 x 35 =
1400
Total Quantity
Required
(A + B)
480 + 1400 =
1880
19
Suspensions
05 Bottles
05 x 12 = 60
05 x 35 = 175
60 + 175 = 235
Sachets
05 Sachets
05 x 12 = 60
05 x 35 = 175
60 + 175 = 235
3.
Dry Powder Injections
05 Vials
05 x 12 = 60
05 x 35 = 175
60 + 175 = 235
4.
Semi Solid
02 Tubes
02 x 12 = 24
02 x 35 = 70
24 + 70 = 94
02 Bottles
02 x 12 = 24
02 x 35 = 70
24 + 70 = 94
5.
6.
7.
Cream / Ointment /
Gel
Liquid (Oral)
Liquid Syrup /
Suspension
Sterile Liquids
Infusion
02 Vials
02 x 12 = 24
02 x 35 = 70
24 + 70 = 94
Injection
05 Amps./
Vials
05 x 12 = 60
05 x 35 = 175
60 + 175 = 235
Eye Drops
02 Packs
02 x 12 = 24
02 x 35 = 70
24 + 70 = 94
Biological Products
Pre-Filled Syringe
(PFS)
05 PFS
05 x 12 = 60
05 x 35 = 175
60 + 175 = 235
Liquid vials
05 Vials
05 x 12 = 60
05 x 35 = 175
60 + 175 = 235
Lyophilized vials
05 Vials
05 x 12 = 60
05 x 35 = 175
60 + 175 = 235
Ampoules
05
Ampoules
05 x 12 = 60
05 x 35 = 175
60 + 175 = 235
Import of raw material:

For conducting Stability Studies of Lab Scale and Pilot Batches raw materials will be imported
through courier for required quantities only without concurrence of DRAP
Evaluation of results:
20
The data is to be evaluated systematically for significant changes (exceeding the specified/
allowed Limits) in particular attributes of different dosage forms i.e. Description / Physical
appearance, Assay / Potency, PH, Dissolution rate and Disintegration time, etc.
Acceptance criteria:
All products must comply with the physical, chemical, microbial and biological (where
applicable) parameters specified in specification of finished product and the product should show
no significant changes throughout the period of stability studies.
Stability data for registration of the product:
The data of accelerated stability studies of one lab scale batch is to be submitted for registration
of the product. If accelerated stability studies data of initial one & three months testing indicates
no significant changes from initial, the data may be submitted for registration purpose with the
commitment/undertaking to do stability studies up to 6 months; applicants will submit 6 months
data to DRB for considering their drug registration applications.
Stability data-Post-registration:
On completion of accelerated stability studies and real time stabilities of one lab scale
batch and two pilot batches, data will be submitted to DRAP
Ongoing stability record of accelerated and long term stability study of retained samples
of first three commercial batches should be maintained in the premises for record
Submitted for consideration of the board.
Case No. 04: Registration applications of new drug manufacturing licenses
21
Evaluator II
Sr.
No
.
Name
and
address
of
Manufacturer /
Applicant
Brand Name
(Proprietary name
+ Dosage form +
Strength)
Composition
Pharmacological
Group
Finished product
specification
1.
2.
3.
M/s
Amaan
Pharma 30km,
Sheikhupura
Road Lahore.
DML
No.
000808 dated:
25-02-15
Liquid
Injection
Ampoule
(General)
No. F.1-6/2013Lic dated 2nd
March, 2015
-do-
-do-
Type of Form
Initial
diary.
date,
Fee including
differential fee
Demanded
Price / Pack
size
International
status in stringent
regulatory
agencies
Me-too status
GMP status as
depicted
in
inspection report
(dated)
Aqua Pro Injection
Form 5
Each
ampoule
contains:
Water for Injection
(B.P) ..5ml
(Solvent / Diluent)
(BP Spec.s)
Dy.No: 1448
Dated: 06-032015
Rs. 20000/Rs. 650/- 5ml
100 ampoule
Kamevil Injection
Form 5
Not provided
Each 2ml contains:

Pheniramine
Maleate
(B.P)
.45.5mg
(Antiallergic)
(Manufacturers
Spec.s)
Dy.No: 1447
Dated: 06-032015
Rs. 20000/Rs. 450/-Pack
of 100 ampoule
of 2ml
Allervil Injection
Indus Pharma
Kamefenac
Injection
Form 5
Voltral of
Novartis UK
Dy.No: 1446
Each 3ml contains: Dated: 06-03Diclofenac Sodium 2015
.75mg
Rs. 20000/-
Remarks / Observations
BNF : Water for

Injection
New DML
1.International availability in
US-FDA, EMA, Health
Canada, TGA & MHLW for
same generic, dosage form
& strength not provided/not
confirmed.
2. Firm has claimed that the
formulation is available in
Bangladesh.
Amefenac
Injection
22
4.
5.
6.
-do-
-do-
-do-
(Non
Narcotic
Analgesic / Antiinflammatory)
(Manufacturers
Spec.s)
Kamefenac
Plus
Injection
-do-
Ameer Pharma
Form 5
Not provided
Dy.No: 1445
Each 3ml contains: Dated: 06-03Diclofenac Sodium 2015
(B.P) 75mg
Rs. 20000/Lignocaine
HCl Rs. 230/-Pack
(B.P)20mg
of 3ml 5
(Non
Narcotic ampoule
Analgesic / Antiinflammatory)
(Manufacturers
Spec.s)
D.J.Mole Injection Form 5
Diclo-Cane
Injection
Ameer Pharma
(R.No 054219)
Each 2ml contains:

Paracetamol (B.P)
.300mg
Lignocaine-HCl
(B.P)20mg
Dy.No: 1451
Dated: 06-032015
Rs. 20000/Rs. 90/-Pack of
2ml
5
ampoule
Chikymol-L
(Ameer Pharma
R. No. 047000)
Form 5
Not provided
Dy.No: 1452
Dated: 06-032015
Rs. 20000/Rs. 400/-Pack
of 25 ampoule
No-Spa Injcetion
(Sanofi Aventis)
Form 5
Approved in M248
Non-Norcotic
Analgesic
Antipyretic
(Manufacturers
Spec.s)
Maqverine
Injection
Each 2ml contains:
Drotaverine
HCl
.40mg
7.
Rs. 650/-Pack
of 100 ampoule
Anticholinergic and
analgesic
Mecobalamine
Injection
Each ml contains:
Dy.No: 1453
Dated: 06-03-
Not provided
US-FDA, EMA, Health
confirmed.
US-FDA, EMA, Health
confirmed.
US-FDA, EMA, Health
confirmed.
Elgin (Novartis)
23
Mecobalamine (JP)
500mcg
8.
-do-
Coenzyme-type
Vitamin B12
(JP)
Maqcine Injection
Each ml contains:
Hyoscine-Nbutylbromide.20
mg
9.
10.
-do-
-do-
Anticholinergic and
analgesic
(BP Spec.s)
Apegent Injection
Each ml contains:
Gentamycin
Sulphate(USP)
equivalent
to
Gentamycin base
40mg
(Aminoglycoside /
Antibiotics)
(USP Spec.s)
Lincomycin
Injection
Each 2ml contains:
Lincomycin HCl
monohydrate
(USP) equivalent to
Lincomycin
base.600mg
LincosamideAntibiotics
2015
Rs. 20000/Rs. 660/-Pack
of 10 ampoule
Form 5
Dy.No: 1457
Dated: 06-032015
Rs. 20000/Rs. 600/-Pack
of 30 ampoule
Form 5
Dy.No: 1450
Dated: 06-032015
Rs. 20000/Rs. 250/-Pack
of
2ml
5
ampoule
Form 5
Dy.No: 1449
Dated: 06-032015
Rs. 20000/Rs. 250/-Pack
of
BNF : Buscopan
(Boehringer
Ingelheim) , vol
of inj is 1ml
Buscopharm
Injection
(Epharm Lab)
BNF : Cidomycin
(Sanofi-Aventis)
Genticyn
Injection
(Ray Pharma)
FDA: Lincocin
Lincocin
Injection
Pfizer
5
2ml
ampoule
(USP Spec.s)
11.
-doLiquid
Injection
Progesterone
Injection
Each ml contains:
Progesterone (USP)
Form 5
Dy.No: 1462
Dated: 06-03-
BNF: Gestone
(Nordic)
1.Me-too status not confirmed.
Not confirmed
24
12.
Ampoule
(Hormones)
March, 2015
-do-
..50mg
Progestogen
(USP Spec.s)
Apevinan Injection
Each ml contains:
Hydroxyprogestero
ne Caproate (USP)
250mg
Oestradiol Valerate
(USP)5mg
13.
-do-
Oestrogen/Progesto
gen (Hormone)
(Manufacturer
s Spec.s)
Kamelone-25
Injection
Each ml contains:
Nandrolone
Decanoate (USP)
.25mg
2015
Rs. 20000/Rs. 130/-Pack
of 1ml
10 ampoule
Form 5
Not provided
Dy.No: 1465
Dated: 06-032015
Rs. 20000/Rs. 110/-Pack
of
1ml
x
1
ampoule
Gravibinan
Injection
Schering
Form 5
Not provided
Dy.No: 1446
Dated: 06-032015
11ml ampoule
Deca-durabolin
Injection (OBS
Pharma)
Anabolic Steroid
US-FDA, EMA, Health
confirmed.
US-FDA, EMA, Health
confirmed.
Firm
has
claimed
that
the
South Afirca.
(USP)
14.
-do-
Kamelone-50
Injection
Form 5
Each ml contains:
Nandrolone
Decanoate(
.50mg
USP)
Dy.No: 1467
Dated: 06-032015
11ml ampoule
BNF: DecaDurabolin
(MSD)
Deca-durabolin
Injection (OBS
Pharma)
Anabolic Steroid
15.
-do-
(USP)
Apelone Injection
Form 5
Not provided
Each ml contains:
Nandrolone
Dy.No: 1463
Dated: 06-03-
Durabolin
Injection
(OBS)
US-FDA, EMA, Health
25
Phenpropionate(US
P) .25mg
16.
-do-
Anabolic Steroid
(USP)
Jaberone Injection
Each ml contains:
Testosterone
Enanthate (USP)
250mg
17.
18.
-do-
-do-
Androgen / Sex
Hormone
(USP)
Testerone-100
Injection
Each ml contains:
Testosterone
propionate (B.P)
30mg
Testosterone
phenylpropionate
(B.P)60mg
Testosterone
Isocaproate (B.P)
60mg
Testosterone
Decanoate (B.P)
100mg
(Androgen / Sex
Hormone)
(Manufacturers
Spec.s)
Oxytocin-5
Injection (I/M, I/V)
Each ml contains:
Oxytocin .5IU
Oxytocic
(USP)
2015
Rs. 20000/Rs. 130/-Pack
of 1ml
3 ampoule
Form 5
Dy.No: 1464
Dated: 06-032015
Rs. 20000/Rs. 275/-Pack
of
1ml
3
ampoule
Form 5
Dy.No: 1470
Dated: 06-032015
Rs. 20000/Rs. 210/-Pack
of
1ml
3
ampoule
Form 5
Dy.No: 1486
Dated: 06-032015
Rs. 20000/Rs. 650/-Pack
of
1ml 100
ampoule

confirmed. FDA approved
DURABOLIN
is
discontinued.
BNF:
Testosterone
Enantate (Nonproprietary)
Testovirone
Injection
(Bayer)
BNF: Sustanon
250 (MSD)
Sustanon (OBS)
BNF:Syntocinon
(Alliance)
Syntocinon
Injection
Novartis
26
19.
-do-
Oxytocin-10
Injection (I/M, I/V)
Each ml contains:
Oxytocin .10IU
Oxytocic
(USP)
20.
-do-
Form 5
Each ml contains:
Dy.No: 1471
Dated: 06-032015
Rs. 20000/Rs. 130/-Pack
of
1ml
3
ampoule
(Oestrogenic
Hormone)
(USP)
22.
-doLiquid
Injection
ampoule
(Steroid)
March, 2015
-do-
Dy.No: 1469
Dated: 06-032015
Rs. 20000/Rs. 600/-Pack
of
1ml 100
ampoule
Ostogen Injection
Estradiol
Valerate.5mg
21.
Form 5
Betasone Injection
Form 5
Each ml contains:
Betamethasone (As
Sodium Phosphate)
..4mg
Dy.No: 1459
Dated: 06-032015
Rs. 20000/Rs. 160/-Pack
of
1ml
5
ampoule
Glucocorticoid
(USP)
Kamedex
Injection
4mg
Each ml contains:
Dexamethasone
disodium
Phosphate eq. to
Dexamethasone
Phosphate .4mg
Form 5
Dy.No: 1456
Dated: 06-032015
Rs. 20000/Rs. 250/-Pack
of
1ml
25
ampoule
BNF:Syntocinon
(Alliance)
Syntocinon
Injection
Novatis
Not provided
Ovlogen
Injection Zafa
US-FDA, EMA, Health
confirmed.
BNF : Betnesol
(RPH)
Betnesol
Injection
GSK
BNF:
Dexamethasone
(Non-proprietary)
Dexamex
Injection
(Bosch)
27
Glucocorticoid
(USP Spec.s)
23.
-do-
Kamedex
Injection
1mg
Each ml contains:
Dexamethasone
Sodium Phosphate
eq.
to
Dexamethasone
Phosphate .1mg
24.
-do-
Glucocorticoid
(USP)
Kamecort Injection
I/M, I/G
Each ml contains:
Triamcinolone
Acetonide40mg
(Glucocorticoid)
(BP Spec.s)
25.
-do-
Kamedrol-Depo
Injection
Each ml of aqueous
suspension
contains:
Methylprednisolon
e Acetate.40mg
Glucocorticoid
(BP Spec.s)
26.
-do-
Prelone-15
Injection
Each ml contains:
Prednisolone
Sodium Phosphate
.15mg
Form 5
Not provided
Dy.No: 1485
Dated: 06-032015
Rs. 20000/Rs.
130.57/Pack of
1ml
25
ampoule
Not confirmed
Form 5
BNF: Kenalog
Intraarticular/Intramus
cular
(Squibb)
Dy.No: 1455
Dated: 06-032015
1ml
1
ampoule
Form 5
Dy.No: 1454
Dated: 06-032015
Rs. 20000/Rs. 200/-Pack
of
1ml
1
ampoule
Form 5
Dy.No: 1460
Dated: 06-032015
Rs. 20000/Rs. 150/-Pack
of
US-FDA, EMA, Health
confirmed.
2.Me-too
status
needs
confirmation.
Kenacort A
(GSK)
BNF :
Medrone
Depo-
(Pharmacia)
Depo-medrol
Injection(Pfizer)
Not provided
Not provided
US-FDA, EMA, Health
confirmed. BNF approved
Gestone (Nordic) strength
is 50mg/ml.
28
27.
-do-
Glucocorticoid
(USP)
1ml
ampoule
Prelone-30
Injection
Form 5
Each ml contains:
Prednisolone
Sodium Phosphate
.30mg
Glucocorticoid
(USP)
28.
29.
M/S Winthrox
Laboratories
(Pvt.) Ltd. Plot.
No. K219A,
S.I.T.E. Phase
II,
Super
Highway
Karachi.
DML
No
(000807) dated
25.02.15
Eye
Drops
(General)
Section No. F.
1-38/2011-Lic
dated 2nd March,
2015.
-do-
Dy.No:
Dated: 06-032015
Rs. 20000/Rs. 200/-Pack
of
1 ampoule
Optibrex-D
Eye
Drops
Contains:- Each ml
of
suspension
contains:
Tobramycin (USP)
.. 3 mg &
Dexamethasone
(USP). 1mg.
(Antibacterial with
Corticosteroid)
(USP Spec.s)
Form 5
26-03-2015
(Dy. No. 1895)
Rs. 20,000/Rs.280.00 per
pack of 5 ml.
Prednimus
Eye
Drops
Each
ml
of
suspension
contains:
Prednisolone
acetate (USP)..
10 mg.
Form 5
26-03-2015
(Dy. No.1902)
Rs. 20,000/Rs.80.00
per
pack of 5 ml.
(Corticosteroid)
Not provided
Not provided
US-FDA, EMA, Health
confirmed. BNF approved
Gestone (Nordic) strength
is 50mg/ml.
2.Firm has provided reference
of Prednisolone sodium
phosphate Injection Simpex
pharma (New Delhi India).
FDA: Tobradex
Eye Drops
(Alcon)
Bradex Eye
Drops (Opal
Labs./Azron)
Grant of DML by
way of
formulation
recommended
(26.12.2014).
BNF: Drops
(Allergan)
Pred Forte Eye
Drops
(Allergan/Barrett
Hodgson)
Grant of DML by
way of
formulation
29
recommended
(26.12.2014).
(USP Spec.s)
30.
31.
32.
33.
-do-
-do-
-do-
-do-
Optinac Eye Drops

Each
ml
of
suspension
contains:
Nepafenac..
1mg
(Non-Steroidal
Anti-Inflammatory
(NSAID))
(Manufacturers
Spec.s)
Optigel 0.2 % Eye
Drops Gel
Each
gram
contains:
Polyacrylic
Acid
(Carbomer) (BP)
.2mg
(Eye Lubricant)
(B.P Spec.s)
Form 5
26-03-2015
(Dy. No.1900)
Rs. 20,000/Rs.400.00 per
pack of 5 ml.
Nevanac Eye
Drops (Alcon)
Form 5
18-03-2015
(Dy. No.1897)
Rs. 20,000/Rs.150.00 per
pack of 10 gm.
BNF: Viscotears
liquid gel (Alcon)
Optiket 0.5 % Eye

Drops
Each ml contains:
Ketorolac
Tromethamine
(USP)
.. 5mg
(Non-Steroidal
Anti-Inflammatory
(NSAID))
(Manufacturers
Spec.s)
Nazoline
Eye
Drops
Each ml contains:
Naphazoline HCl
(USP).. 0.25mg
Pheniramine
Form 5
26-03-2015
(Dy. No.1904)
Rs. 20,000/Rs.200.00 per
pack of 5 ml.
Nevanac Eye
Drops (Alcon)
Grant of DML by
way of
formulation
recommended
(26.12.2014).
Local: Visol Gel

Eye Drops (Atco)
Rs.124.00
Grant of DML by
way of
formulation
recommended
(26.12.2014).
BNF : Acular
(Allergan)
Dylac Eye Drops
(Opal
Labs./Azron)
Grant of DML by
way of
formulation
recommended
(26.12.2014).
Form 5
26-03-2015
(Dy. No.1898)
Rs. 20,000/Rs.80.00
per
pack of 15 ml.
FDA:
Naphcon-A Eye
Drops (Alcon)
Nafamine Eye
Drops (Ethical
30
Maleate
(USP)
.. 3mg
(Anti-histamine /
Decongestant/
Sympathomimetic)
(USP Spec.s)
34.
35.
36.
-do-
Labs.)
Grant of DML by
way of
formulation
recommended
(26.12.2014).
Optim Eye Drops

Each ml contains:
Timolol
maleate
equivalent to
Timolol
(USP)
.. 5mg
(Beta Blocker)
(USP Spec.s)
Form 5
26-03-2015
(Dy. No.1901)
Rs. 20,000/Rs.150.00 per
pack of 5 ml.
M/s
Mission
Pharmaceutical
sPvt.) Ltd. Plot
No.
A-94,
S.I.T.E. SUPER
HIGHWAY
KARACHI
Pakistan.
DML
No.
000809, dated
25-02-2015)
(Capsule
Cephalosporin
section:
dated
27-02-2015
MEPROZIL
Capsule
( Cefprozil 500mg)
Form 5
06-04-2015
( 2382)
Rs. 20,000/As Per SRO
1
x
10S
Blister Pack
Demanded
price Rs. 550.0
-do-
CEFOXIL
(Cefadroxil 500
mg )
Capsules
Each
contains:-
capsule
Cefprozil
monohydrate
(USP) equivalent to
500 mg Cefprozil
BNF: Timoptol
(MSD)
Meditim Eye
Drops (Medipak)
Grant of DML by
way of
formulation
recommended
(26.12.2014).
Cefprozil Teva
Teva, United
States
ZILPRO
WILSHIRE
/HORIZON
US-FDA, EMA, Health
confirmed.
New DML
(Oral
2nd
generation
cephalosporin
antibiotic)
(Manufacturers
Spec.s)
Each
contains:-
capsule
Form 5
06-04-2015
( 2387)
1
x
12S
Blister Pack
Demanded
CEFADROXIL
500mg Caps
USFDA
NEUCEF
500mg Capsule
Sami
New DML
31
Cefadroxil
Monohydrate
(USP) equivalent to
500 mg Cefadroxil
price Rs. 190.0
(Oral cephalosporin
antibiotic)
USP Specification
for finished product
37.
-do-
FACLOR
( cefaclor 250 mg)
Capsules
Each
contains:-
capsule
Cefaclor
monohydrate
equivalent to 250
mg Cefaclor
Form 5
06-04-2015
(2393)
1
x
12S
Blister Pack
Demanded
price Rs. 260.0
BNF: Keftid
Form 5
06-04-2015
(2394 )
1
x
12S
Blister Pack
Demanded
price Rs. 490.0
BNF:
Distaclor
(Flynn)
Form 5
06-04-2015
(2381)
KEFLEX
500mg Caps
USFDA
Ceclor (AGP)
New DML
Oral cephalosporin
antibiotic
USP Specification
38.
-do-
FACLOR
( cefaclor 500mg)
Capsules
Each
capsule
contains:cefaclor
monohydrate
equivalent to 500
mg cefaclor
Ceclor (AGP)
New DML
Oral cephalosporin
antibiotic
USP Specification
39.
-do-
LEXIM
(Cephalexin 500
mg)
32
Capsules
Each
capsule
contains:Cephalexin
monohydrate
equivalent to 500
mg Cephalexin

1
x
12S
Blister Pack.
Demanded
price Rs. 200.0
CEPOREX
500mg Caps
Gsk
Form 5
06-04-2015
(2383)
1
x
12S
Blister Pack.
Demanded
price Rs. 100.0
KEFLEX
250mg Caps
USFDA
Form 5
06-04-2015
( 2397)
1
x
12S
Blister Pack.
Demanded
price Rs. 244.7
BNF: Nicef
Form 5
06-04-2015
BNF: Nicef
New DML
Oral cephalosporin
antibiotic
40.
-do-
USP Specification
LEXIM
(Cephalexin 250
mg) Capsules
Each capsule
contains:Cephalexin
monohydrate
equivalent to 250
mg Cephalexin
CEPOREX
250mg Caps
Gsk
New DML
Oral cephalosporin
antibiotic
USP Specification
41.
-do-
MEPRADIN
( Cephradine 500
mg) Capsules
Each capsule
contains:Cephradine (USP)
500 mg
Oral cephalosporin
antibiotic
USP Specification
42.
-do-
MEPRADIN
( Cephradine 250
Velosef
Bristol Myres
New DML
33
mg) Capsules
Each capsule
contains:Cephradine (USP)
250 mg
Oral cephalosporin
antibiotic
USP Specification
43.
-do(Oral Dry
powder
Suspension
section
Cephalosporin
dated
27-022015
CEFOXIL Oral dry

suspension
( Cefadroxil125
mg)
Each 5 ml
Contains:Cefadroxil
monohydrate
equivalent to 125
mg Cefadroxil
( 2398)
1
x
12S
Blister Pack.
Demanded
price
Rs.
124.55
Velosef
Form 5
06-04-2015
(2388)
60 ml Bottle
Pack.
Demanded
price
Rs.
161.63
FDA: Cefadroxil
Form 5
06-04-2015
(2399)
FDA: Cefadroxil
Bristol Myres
New DML
(Ranbaxy)
Duricef By GSK
New DML
Ist-generation Oral
cephalosporin
antibiotic
USP Specification
44.
-do-
CEFOXIL Oral dry

suspension
(Cefadroxil 250
mg)
Each 5 ml
Contains:Cefadroxil
monohydrate
equivalent to 250
mg Cefadroxil

60 ml Bottle
Pack.
Demanded
price
Rs.
261.80
(Ranbaxy)
Duricef
By GSK
New DML
34
Ist-generation Oral
cephalosporin
antibiotic
USP Specification
45.
-do-

FACLOR Oral dry
suspension
( Cefaclor 125 mg)
Each 5 ml
Contains:Cefaclor
monohydrate
equivalent to 125
mg Cefaclor
Form 5
06-04-2015
( 2395)
60 ml Bottle
Pack.
Demanded
price Rs. 170.0
BNF : Distaclor
(Flynn)
Form 5
06-04-2015
(2385)
60 ml Bottle
Pack.
Demanded
price
Rs.
328.53
BNF : Distaclor
(Flynn)
Form 5
06-04-2015
(2398)
Rs. 20,000/-
Not confirmed
Ceclor By
AGP
New DML
Ist-generation Oral
cephalosporin
antibiotic
USP Specification
46.
-do-

FACLOR Oral dry
suspension
( Cefaclor 250 mg)
Each 5 ml
Contains:Cefaclor
monohydrateequiva
lent to 250 mg
Cefaclor
Ist-generation Oral
cephalosporin
antibiotic
USP Specification
47.
-do-

Mepradin Oral dry
suspension
( CEPHRADINE
250 MG)
Ceclor By
AGP
New DML
Velosef
Bristol Myres
US-FDA, EMA, Health
35
Each 5 ml
Contains:CEPHRADINE
250 mg
1st Generation Oral
cephalosporin
antibiotic
As Per SRO
60 ml Bottle
Pack.
Demanded
price Rs. 210.0
New DML

confirmed.
2.All
US-FDA
approved
brands of formulation
have been discontinued.
Form 5
06-04-2015
(2386)
60 ml Bottle
Pack.
Demanded
price Rs. 120.0
Not confirmed
US-FDA, EMA, Health
confirmed.
2.All
US-FDA
approved
brands of formulation
have been discontinued.
Form 5
06-04-2015
(2396)
30 ml Bottle
Pack.
Demanded
price Rs. 215.0
BNF: Suprax
(Sanofi-Aventis)
USP Specification
48.
-do-

Mepradin Oral dry
suspension
( CEPHRADINE
125 MG)
Each 5 ml
Contains:CEPHRADINE
125 mg
1st Generation Oral
cephalosporin
antibiotic
Velosef
Bristol Myres
New DML
USP Specification
49.
-do-

MIXIME Oral dry
suspension
( Cefixime200 mg)
Each 5 ml
Contains:Cefixime
(AsTrihydrate)
(USP) equivalent
to Cefixime 200
mg.
Cefiget
Getz Pharma
New DML
3rd-generation Oral
cephalosporin
antibiotic
USP Specification
36
50.
-do-

MIXIME Oral dry
suspension
( Cefixime 100 mg)
Each 5 ml
Contains:Cefixime
(AsTrihydrate)
(USP) equivalent
to Cefixime 100
mg.
Form 5
06-04-2015
(2380)
30 ml Bottle
Pack.
Demanded
price Rs. 135.0
BNF: Suprax
(Sanofi-Aventis)
Form 5
16-04-2015
(975)
Rs.20,000/As per SRO/
1x4s
FDA: Fosamax
Plus D (Merck)
Form 5
16-04-2015
(972)
2x10s
BNF:Brexidol(C
hiesi
Pharmaceuticals)
Cyclodex 20 mg
Tablet ( Platinum
Pharmaceuticals
(Pvt) Limited)
Cefiget
Getz Pharma
New DML
3rd-generation Oral
cephalosporin
antibiotic
51.
52.
M/S LINTA
Pharmaceutical
s (Pvt) Limited
plot No 03,
Street No S-5,
National
Industrial Zone
Rawat,
Islamabad.
DMLNo 000810
dated 02-042015
Tablet General
No.F. 1-4/2011Lic ,
Dated 03-042015)
-do-
USP Specification
Nate D
70mg/70mcg
Tablets
Each Tablet
contains:
Alendronate (as
Alendronate
Sodium) (B.P)
..70 mg
Cholecalciferol
(B.P) 70 mcg
(2800 IU)
(Bisphosphonate/Vi
tamin D analogue)
(Manufacturers
Spec.s)
Relin Tablets
Each Tablet
Contains:
Piroxicam-betacyclodextrin eq. to
Piroxicam20
mg
(Non- Steroidal
Anti-inflamatory)
(Manufacturers
Spec.s)
Drate Plus D 70
mg/ 70 mcg
Tablet(SJ&G
Fazul Illahi
Karachi)
Grant For
registration of
drugs of new
license dated 0204-2015
Grant For
registration of
drugs of new
37
53.
54.
-do-
-do-
Fude Tablets
Each Film coated
Tablet
Contains:
Sodium Fusidate
(B.P)
250 mg
BP Specification
(Anti Biotic)
Eto Tablets
Each Film coated
tablet coated tablet
contains:
Etoricoxib..60
mg
(NSAID)
(Manufacturers
Spec.s)
Form 5
16-04-2015
(976)
2x10s
Form 5
16-04-2015
(973)
10s
FDA:
Fucidin(LEO
Pharmaceuticals)
Fusiderm
250 mg Tablet
( Martin Dow
Limited)
1.Potentiometer is required for

assay. Firm has submitted
an undertaking that they
will
purchase
before
production of product.
Grant For
registration of
drugs of new
FDA: Arcoxia
(MSD)
Starcox
60 mg Tablet
(Getz Pharma
(Pvt.)
Limited)
Grant For
registration of
drugs of new
55.
56.
-do-
-do-
Hicox Tablets
Each film coated
tablet contain:
Moxifloxacin (as
HCl)..400 mg
(Quinolone)
(Manufacturers
Spec.s)
Biwa Tablets
Each film coated
tablet contain:
Ibandronic acid (as
Sodium
Monohydrate)
..150 mg
(Bisphosphonate)
Form 5
17-04-2015
(967)
5s
Form 5
17-04-2015
(974)
1s
BNF: Avelox
(Bayer)
Morax
400mg Tablet
(Global
Pharmaceuticals
(Pvt) Limited)
Grant For
registration of
drugs of new
FDA: Boniva
(Roche)
Ibandro
150 mg tablet
(PharmEvo (Pvt)
Limited)
38
(Manufacturers
Spec.s)
57.
58.
59.
60.
-do-
-do-
-do-
-do-
Ozlin Tablets
Each film coated
tablet contain:
Linezolid..600
mg
(Odazolidinone,
Anti-Infective)
(Manufacturers
Spec.s)
Noxi Tablets
Each film coated
tablet contain:
Lornoxicam..8
mg
(NSAID)
(Manufacturers
Spec.s)
Form 5
17-04-2015
(970)
10s
Form 5
17-04-2015
(968)
10s
Tril-P Tablets
Each film coated
tablet contains:
Paracetamol (USP)
325mg
Tramadol
HCL (USP)
.37.5mg
(Non-opiod
Analgesic)
(USP
Specifications)
Form 5
17-04-2015
(969)
10s
Alfa-C Tablets
Each uncoated
Form 5
17-04-2015
Grant For
registration of
drugs of new
FDA: Zyvox
(Pharmacia
Limited UK)
Ecasil 600 mg
Tablet
(Sami
Pharmaceuti
cals,
Karachi)
Grant For
registration of
drugs of new
Xefo Rapid
(Takeda Ireland)
approved M-246
Lornox 8 mg
Tablet (Ray
Pharma Karachi)
Grant For
registration of
drugs of new
FDA: Ultracet
tablets
(Janssen)
Tonoflex-P 325
mg/ 37.5 mg
Tablets (Sami
Karachi)
Grant For
registration of
drugs of new
Not provided
US-FDA, EMA, Health
39
61.
-doCapsule General
No.F. 1-4/2011Lic (M-000810
Dated 02-042015)
tablet contains:
Alfacalcidol
0.5 mcg
Elemental Calcium
(as Calcium
Carbonate). 400
mg
(Vitamin-D
Analogue, Calcium
Supplement)
(Manufacturers
Spec.s)
Alfa-2 Capsules 0.5
mcg
Each capsule
contains
Alfacalcidol (B.P)
..0.5 mcg
(Vitamin D
analogue)
(971)
10s
-do-
Alfa-2 Capsules 1
mcg
Each capsule
contains
Alfacalcidol (B.P)
.. 1 mcg
(Vitamin D
analogue)
Form 5
17-04-2015
(981)
3 x 10s
Form 5
17-04-2015
(982)
3 x 10s
(Manufacturers
Spec.s)
63.
-do-
Blin Capsules
Each capsule
contains:
Pregabalin
150mg
(Anti epileptic
anticonvulsant
agent)
(Manufacturers
Spec.s)

confirmed.
Grant For
registration of
drugs of new
(Manufacturers
Spec.s)
62.
Bonecare-C 0.5
mcg/1000 mcg
Tablet (Schazoo
Zaka (Pvt)
Limited Lahore)
Form 5
17-04-2015
(979)
2 x 7s
FDA: One-Alpha
(Leo
Pharmceuticals
Denmark)
Biodol 0.5 mcg
capsules
(Bio-Labs Pvt
Limited
Islamabad)
Grant For
registration of
drugs of new
BNF: Rocaltrol
(Roche)
Alpha-Plus 01
mcg capsules
(Rotex Medica
(Pvt) Limited)
1.Quantity of active is very

less. Registration Board is
referring such formulations
for
product
specific
inspection
for
manufacturing and testing
facility.
1.Quantity of active is very

less. Registration Board is
referring such formulations
for
product
specific
inspection
for
manufacturing and testing
facility.
Grant For
registration of
drugs of new
FDA: LYRICA
Capsules (25, 50,
75, 100, 150,200,
225 and 300mg)
(Pfizer
Pharmaceuticals)
GABICA
Capsules (50, 75,
100,
40
150 and 300mg)

(Getz Pharma
Pakistan)
64.
-do-
Blin Capsules
Each capsule
contains:
Pregabalin
300mg
(Anti epileptic
anticonvulsant
agent)
Form 5
17-04-2015
(980)
2 x 7s
GABICA
Capsules (50, 75,
100,
150 and 300mg)
(Getz Pharma
Pakistan)
(Manufacturers
Spec.s)
65.
-do-
Rush capsule
20mg
Each Capsule
Contains:Esomeprazole( as
Esomeprazole
magnesium
trihydrate enteric
coated pellets)
(USP)
20 mg
(Proton Pump
Inhibitor)
(USP Spec.s)
{Source of pellets:
M/s . Lee Pharma
Ltd., Sy. No. 199,
Plot No. 3 & 4,
D.No. 5-9-265/1 &
2,
Rajeevgandhinagar,
Prasanthinagar I.E,
Kukatpally, Ranga
Grant For
registration of
drugs of new
FDA: LYRICA
Capsules (25, 50,
75, 100, 150,200,
225 and 300mg)
(Pfizer
Pharmaceuticals)
Form 5
17-04-2015
(984)
Rs.1,00,000/As per SRO/
2 x 7s
Grant For
registration of
drugs of new
NEXIUM
Capsule
(AstraZeneca)
1.Legalized GMP certificate of

pellets and stability studies
are required.
E-CAP 40mg
Capsules
((Brookes
Pharmaceuticals
(Pvt) Limited))
Grant For
registration of
drugs of new
41
66.
67.
-do-
-do-
Reddy District,
Telangana State,
India}
Rush capsule 40mg
Each Capsule
contains
Esomeprazole( as
Esomeprazole
magnesium
trihydrate enteric
coated pellets) eq.
to
Esomeprazole40
mg
(Proton Pump
Inhibitor)
(USP Spec.s)
{Source of pellets:
M/s . Lee Pharma
Ltd., Sy. No. 199,
Plot No. 3 & 4,
D.No. 5-9-265/1 &
2,
Rajeevgandhinagar,
Prasanthinagar I.E,
Kukatpally, Ranga
Reddy District,
Telangana State,
India}
Najat Capsule
250mg
Each capsule
Contains
Azithromycin
dihydrate (USP) eq.
to
Azithromycin
250mg
(Macrolide
Antibiotic)
Form 5
17-04-2015
(985)
2 x 7s
-do-
Ospra capsule
20mg
Each Capsule
Contains:
Omeprazole
(enteric coated

are required.
E-CAP 40mg
Capsules
(Brookes
Pharmaceuticals
(Pvt) Limited)
Grant For
registration of
drugs of new
Form 5
17-04-2015
(983)
10s
BNF:
Zithromax
(Pfizer)
Zitamax 250mg
Capsules
Pfizer
Laboratories
Ltd.
Grant For
registration of
drugs of new
(USP
Specifications)
68.
NEXIUM
Capsule
(AstraZeneca)
Form 5
17-04-2015
(977)
2 x 7s
BNF: Losec
(AstraZeneca)
RISEK 20mg
Capsule
Getz Pharma

are required.
42
69.
70.
-do-
-do-
pellets) eq. to
Omeprazole...
20mg
(Proton Pump
Inhibitor)
(USP Spec.s)
{Source of pellets:
M/s . Lee Pharma
Ltd., Sy. No. 199,
Plot No. 3 & 4,
D.No. 5-9-265/1 &
2,
Rajeevgandhinagar,
Prasanthinagar I.E,
Kukatpally, Ranga
Reddy District,
Telangana State,
India}
Ospra capsule
40mg
Each Capsule
Contains:
Omeprazole
(enteric coated
pellets) eq. to
Omeprazole...
40mg
(Proton Pump
Inhibitor)
(USP Spec.s)
{Source of pellets:
M/s . Lee Pharma
Ltd., Sy. No. 199,
Plot No. 3 & 4,
D.No. 5-9-265/1 &
2,
Rajeevgandhinagar,
Prasanthinagar I.E,
Kukatpally, Ranga
Reddy District,
Telangana State,
India}
Votsa capsule 30mg
Each Capsule
Contains:
Lansoprazole
(enteric coated
pellets) eq. to
Lansoprazole
(USP) ... 30mg
(Proton Pump
(Pvt.)
Ltd
Grant For
registration of
drugs of new
Form 5
17-04-2015
(978)
2 x 7s
BNF: Losec
(AstraZeneca)
RISEK 40mg
Capsule
Getz Pharma
(Pvt.)
Ltd

are required.
Grant For
registration of
drugs of new
Form 5
17-04-2015
(986)
2 x 7s
FDA: Prevacid
(Novartis
Pharmaceuticals)
Inhibitol 30mg
Capsule
(Highnoon
Laboratories
Limited)
1.Source , Legalized GMP

certificate of pellets and
stability
studies
are
required.
43
Inhibitor)
71.
-doCapsule
Cephalosporin
No.F. 1-4/2011Lic (DML No000810)
Dated 03-042015
(USP Spec.s)
{Source of pellets:
M/s . Lee Pharma
Ltd., Sy. No. 199,
Plot No. 3 & 4,
D.No. 5-9-265/1 &
2,
Rajeevgandhinagar,
Prasanthinagar I.E,
Kukatpally, Ranga
Reddy District,
Telangana State,
India}
Kix Capsules 250
mg
Each hard gelatin
capsule contains:Cephalexin
monohydrate USP
eq. to Cephalexin
.250mg.
Grant For
registration of
drugs of new
Form 5
17-04-2015
(987)
-do-
Grant For
registration of
drugs of new
(Cephalosporin)
Kix Capsules 500

mg
Each hard gelatin
capsule contains:Cephalexin
monohydrate eq. to
Cephalexin
.500mg.
(Cephalosporin)
(USP Specs)
Ciporex 250 mg
capsules (GSK
Pakistan Private
Limited)
12s
(USP Specs)
72.
BNF: Ceporex
(Co-Pharma)
Form 5
17-04-2015
BNF: Ceporex
(Co-Pharma)
(988)
Ciporex 250 mg
capsules (GSK
Pakistan Private
Limited)
12s
Grant For
registration of
drugs of new
license dated 02-
44
04-2015
73.
-do-
Velo Capsules 250

mg
Each hard gelatin
capsule contains:Cephradine
monohydrate USP
eq. to
Cephradine.25
0mg.
Form 5
17-04-2015
(989)
Grant For
registration of
drugs of new
(USP Specs)
-do-
Velo Capsules 500

mg
Each hard gelatin
capsule contains:Cephradine
monohydrate USP
eq. to
Cephradine.50
0mg.
Form 5
17-04-2015
Osef Capsules 500

mg
Each hard gelatin
capsule contains:Cefadroxil
monohydrate USP
eq. to Cefadroxil
.500mg.
Velosef 500 mg
capsules (GSK
Pakistan Private
Limited)
12s
Grant For
registration of
drugs of new
(USP Specs)
-do-
BNF: Cefradine
(Non-proprietary)
(990)
(Cephalosporin)
75.
Velosef 250 mg
capsules (GSK
Pakistan Private
Limited)
12s
(Cephalosporin)
74.
BNF: Cefradine
(Non-proprietary)
Form 5
17-04-2015
BNF: Cefadroxil
(Non-proprietary)
(994)
Duricef 500 mg
capsules (GSK
Pakistan Private
Limited)
12s
45
(Cephalosporin)
(USP Specs)
76.
-do-
Teklor Capsules
250 mg
Each hard gelatin
capsule contains:Cefaclor
monohydrate eq. to
Cefaclor
.250mg.
Grant For
registration of
drugs of new
Form 5
17-04-2015
(995)
12s
(Cephalosporin)
BNF: (Non
proprietary)
Ceclor 250 mg
capsules (AGP
healthcare
Private Limited)
Grant For
registration of
drugs of new
(USP Specs)
77.
-do-
Teklor Capsules
500 mg
Each hard gelatin
capsule contains:Cefaclor
monohydrate eq. to
Cefaclor
.500mg.
Form 5
17-04-2015
(996)
12s
(Cephalosporin)
BNF: Distaclor
(Flynn)
Ceclor 500 mg
capsules (AGP
healthcare
Private Limited)
Grant For
registration of
drugs of new
(USP Specs)
78.
-do-
Zix Capsules 200

mg
Each hard gelatin
Form 5
17-04-2015
Not provided/Not
confirmed
Cefim 200 mg
US-FDA, EMA, Health
46
capsule contains:-
(992)
Cefixime trihydrate
eq. to Cefixime
.200mg.
Rs.20,000/-
(Cephalosporin)
5s
As per SRO/
(Manufacturers
Spec.s)
79.
-do-
Zix Capsules 400

mg
Each hard gelatin
capsule contains:Cefixime trihydrate
eq. to Cefixime
.400mg.
Form 5
17-04-2015
(993)
capsules (Hilton
Pharma Private
Limited)

confirmed.
Grant For
registration of
drugs of new
FDA: Suprax
(Lupin
Pharmaceuticals
Inc. USA)

10s
Cefim 400 mg
capsules (Hilton
Pharma Private
Limited)
(Cephalosporin)
Grant For
registration of
drugs of new
(Manufacturers
Spec.s)
80.
-do-
Denar Capsules
300 mg
Each hard gelatin
capsule contains:-
Form 5
17-04-2015
(991)
Cefdinir (USP)
.300mg.
Rs.20,000/-
(Cephalosporin)
12s
-do-
Zix Dry Powder for

suspension 100 mg
Salus 300 mg
capsules (Himont
Pharmaceuticals
Private Limited)
As per SRO/
(USP Specs)
81.
FDA: Cefdinir
(Sandoz)
Form 5
Grant For
registration of
drugs of new
FDA: Suprax
(Lupin
47
Oral dry powder

suspension
Cephalosporin
82.
Each 5 ml
contains:-
17-04-2015
(1016)
Rs.20,000/-
No.F. 1-4/2011-
Cefixime trihydrate
eq. to Cefixime
.100mg.
Lic (M-000810
(Cephalosporin)
30 ml
Dated 02-042015)
(USP Specs)
-do-
Zix Dry Powder for

suspension 200 mg
Each 5 ml
contains:Cefixime trihydrate
eq. to Cefixime
.200mg.
(Cephalosporin)
As per SRO/
-do-
Orid Dry Powder

Drops 50 mg
Each 5ml
contains:-
Form 5
17-04-2015
(1017)
30 ml
FDA: Suprax
(Lupin
Pharmaceuticals
Inc. USA)
Cefim 200 mg/
5ml Dry Powder
for Suspension
(Hilton Pharma
Private Limited)
Grant For
registration of
drugs of new
Form 5
17-04-2015
(1019)
Cefpodoxime as
Proxitel .50mg.
Rs.20,000/-
(Cephalosporin)
50 ml
(USP Specs)
Cefim 100 mg/

5ml Dry Powder
for Suspension
(Hilton Pharma
Private Limited)
Grant For
registration of
drugs of new
(USP Specs)
83.
Pharmaceuticals
Inc. USA)
As per SRO/
FDA:
Cefpodoxim
Proxitel
(Ranbaxy)
Qink 50 mg/ 5ml
Dry Powder for
Suspension
(Wilshire
Laboratories
Private Limited)
Grant For
registration of
drugs of new
48

84.
-do-
Orid Dry Powder

for Suspension 100
mg
Form 5
Each 5ml
contains:-
(1018)
Cefpodoxime as
Proxitel .100mg.
As per SRO/
(Cephalosporin)
17-04-2015
Rs.20,000/-
50 ml
(USP Specs)
85.
-do-
Teklor Dry Powder

for Suspension 125
mg
Form 5
Each 5ml
contains:-
(1020)
Cefaclor
monohydrate eq. to
Cefaclor
.125mg.
As per SRO/
17-04-2015
Rs.20,000/-
60 ml
Teklor Dry Powder

for Suspension 250
mg
Form 5
Each 5ml
contains:-
(1021)
Cefaclor
FDA: Cefaclor
(YUNG SHIN
PHARM)
Ceclor Dry
Powder for
Suspension 125
mg (AGP
healthcare
Private Limited)
Grant For
registration of
drugs of new
(USP Specs)
-do-
Qink 100 mg/

5ml Dry Powder
for Suspension
(Wilshire
Laboratories
Private Limited)
Grant For
registration of
drugs of new
(Cephalosporin)
86.
FDA:
Cefpodoxim
Proxitel
(Ranbaxy)
17-04-2015
Rs.20,000/-
FDA: Cefaclor
(YUNG SHIN
PHARM)
Ceclor Dry
Powder for
Suspension 250
49
monohydrate eq. to
Cefaclor
.250mg.
As per SRO/
60 ml
(Cephalosporin)
Grant For
registration of
drugs of new
(USP Specs)
87.
-do-
Teklor Dry Powder

for Drops 50 mg
Each ml contains:Cefaclor
monohydrate eq. to
Cefaclor .50
mg.
(Cephalosporin)
Form 5
17-04-2015
(1022)
15 ml
-do-
Osef Dry Powder

for Suspension 125
mg
Form 5
Each 5ml
contains:-
(1024)
Cefadroxil
monohydrate eq. to
Cefadroxil
.125mg.
As per SRO/
17-04-2015
Rs.20,000/-
60 ml
(USP Specs)
-do-
Osef Dry Powder

for Suspension 250
mg
Ceclor Dry
Powder for Drops
50 mg (AGP
healthcare
Private Limited)
FDA: Cefadroxil
(Ranbaxy)
Duricef Dry
Powder for
Suspension 125
mg (GSK
Pakistan Private
Limited)
Grant For
registration of
drugs of new
(Cephalosporin)
89.
FDA: Cefaclor
(YUNG SHIN
PHARM),
(250mg/5ml)
Grant For
registration of
drugs of new
(USP Specs)
88.
mg (AGP
healthcare
Private Limited)
Form 5
17-04-2015
FDA: Generic
(AUROBINDO)
Duricef Dry
50
Each 5ml
contains:Cefadroxil
monohydrate eq. to
Cefadroxil
.250mg.
(1025)
60 ml
(Cephalosporin)
(USP Specs)
90.
-do-
Kix Dry Powder

for Suspension 250
mg
Form 5
Each 5ml
contains:-
(1023)
Cephalexin
monohydrate eq. to
Cephalexin.25
0mg.
As per SRO/
17-04-2015
Rs.20,000/-
60 ml
(USP Specs)
M/s Winthrox
Laboratories
(Pvt.) Ltd
K-219-A,
S.I.T.E,
Superhighway
phase II,
Karachi
No. F-I- 38/2011
Lic dated 2nd
March 2015.
Tablet (General)
Section
Wincip 250 mg
Tablet:Each Film Coated
Tablet Content:
Ciprofloxacin (as
HCl) USP 250
mg
Quinolones
Antibiotic,
(USP Spec.s)
Grant For
registration of
drugs of new
BNF: Keflex
(Flynn)
Ciporex Dry
Powder for
Suspension 250
mg (GSK
Pakistan Private
Limited)
Grant For
registration of
drugs of new
(Cephalosporin)
91.
Powder for
Suspension 250
mg (GSK
Pakistan Private
Limited)
Form 5
16-04-2015
(Dy no. 423)
Rs. 20,000/As per DRAP
policy
Cipro 250mg
United Kingdom
Bayer
Pharmaceuticals
Inoquin 250 mg
Tablets
Barret Hodgson
Pharmaceutical
s (Pvt) Ltd
Ciproquin 250
mg Tablets
Macter
Internaional (Pvt)
Ltd
Grant of DML by
way of
51
formulation
recommended
(25.02.2015).
92.
-do-
Wincip 500 mg
Tablet Content:
Ciprofloxacin (as
HCl) USP 500
mg
Form 5
16-04-2015
(Dy no. 422)
policy
Quinolones
Antibiotic,
(Preperation)
(USP Spec.s
93.
-do-
WinFlox 250 mg
Tablet Content:
Levofloaxacin (as
hemihydrate)
USP 250 mg
Quinolones
Antibiotic,
(USP Spec.s)
Form 5
02-04-2015
(Dy no. 419)
policy
Cipro
United Kingdom
Bayer
Pharmaceuticals
Inoquin 500 mg
Tablets
Barret Hodgson
Pharmaceutical
s (Pvt) Ltd
Ciproquin 500
mg Tablets
Macter
Internaional (Pvt)
Ltd
Grant of DML by
way of
formulation
recommended
(25.02.2015).
Levaquin
USA
Janssen
pharmaceuticals
Effiflox 250 mg
Tablet
Sami
Pharmaceuticals
(Pvt) Ltd
Qumic 250 mg
Tablet
Bosch
Pharmaceuticals
(Pvt) Ltd
Grant of DML by
way of
formulation
recommended
(25.02.2015).
52
94.
-do-
WinFlox 500 mg
Tablet Content:
Levofloaxacin (as
hemihydrate)
500 mg
Form 5
16-04-2015
(Dy no. 401)
policy
Quinolones
Antibiotic,
(Preperation)
(USP Spec.s
Levaquin
USA
Janssen
pharmaceuticals
Effiflox 250 mg
Tablet
Sami
Pharmaceuticals
(Pvt) Ltd
Qumic 250 mg
Tablet
Bosch
Pharmaceuticals
(Pvt) Ltd
Grant of DML by
way of
formulation
recommended
(25.02.2015).
New License
95.
-do-
Becyclo Tablet 20
mg
Each Tablet
Contains:
Prioxicam Beta
Cyclodextrin
equivalent to
Piroxicam .20
mg
Anti-Inflammatory
analgesic
(Manufacturers
specification)
Form 5
16-04-2015
(Dy no. 411)
policy
GOOD
Brexidol tablet
20mg
Chiesi
Pharmaceuticals
Limited, UK.
Manufacturer
Chiesi
Farmaceutici
S.p.A., Via
Palermo 26/A,
43100 Parma,
Italy.
Rheumpain tablet
20 mg
Mediate
Pharmaceuticals
Pvt Ltd
Grant of DML by
way of
formulation
recommended
(25.02.2015).
53
New License
96.
-do-
Wintek-xl 500 mg
Tablet
Each
Film
Coated
extended
release
tablet
Contains
Clarithromycin
(USP) 500 mg
Macrolide
Antibiotic
Form 5
16-04-2015
(Dy no. 412)
policy
GOOD
BIAXIN XL
Abbot
Laboritories
Canada
Fascar - XL
500mg
(MAQ
PHARMA)
Claritek XL
500 mg
Getz Pharma
USP specification
Grant of DML by
way of
formulation
recommended
(25.02.2015).
97.
-do-
Noxicam 400 mg
Tablet
Each
Film Coated Tablet
Contains
Moxifloxacin (as
HCl . 400 mg
(Quinolones
Antibiotic)
Form 5
16-04-2015
(Dy no. 415)
policy
Avelox
Bayr Germany
Abomox 400 mg
Tablet
Abbot
Laboritories
(Pvt) Ltd
Izilon 400 mg
Tablet
Bosch
Pharmaceuticals
(Pvt) Ltd
USP specification
Grant of DML by
way of
formulation
recommended
(25.02.2015).
98.
-do-
Zurich
40
mg
Tablet
Each
Film Coated Tablet
Contains
Form 5
16-04-2015
(Dy no. 403)
Rs. 20,000/-
Uloric 40mg
/Tablet
Takeda, United
States; Takeda
Canada.
54
Febuxostat ... 40
mg
Xanthine Oxidase
Inhibitor ,
As per DRAP
policy
Manufacture
specification
99.
-do-
Zurig 40 mg
tablet
Getz
Pharmaceuticals
Pvt Ltd
Lornoxi 8mg Tablet

Each Film Coated
Tablet contains:
Lornoxicam 8 mg
Form 5
16-04-2015
(Dy no. 410)
Rs. 20,000/-
(NSAID)
As per DRAP
policy
Manufacuture
specification
Adenuric
Tablets
A.Menarini
Pharma U.K.
S.R.L.
Grant of DML by
way of
formulation
recommended
(25.02.2015).
XEFO tablet
8.0mg
Takeda UK
Limited
(Approved M246)
Available in Ireland only
Xefo (Pharmevo)
Grant of DML by
way of
formulation
recommended
(25.02.2015).
New License
GOOD
100.
-do-
Paratom
Tablet
37.5/325 mg
Each Film Coated
Tablet Content:
Tramadol HCl
37.5mg
Paracetamol
325mg
Opiate Analogue /
Analgesic
Form 5
16-04-2015
(Dy no. 409)
policy
BNF: Tramacet
Gru nenthal
TONOFLEX
Tablet
Sami
Pharmaceuticals
Grant of DML by
way of
formulation
55
recommended
(25.02.2015).
USP specification
101.
-do-
Uray Capsule
20mg
No. F-I- 38/2011 Each Capsule
Contains
Lic (M-239
Omeprazole
dated 25-02Enteric coated
2015)
pellets (8.5%)
Grant
New equivalent to
Omeprazole ...20m
DML
g
Capsule
Section
Proton
pump
Form 5
16-04-2015
(Dy no. 416)
policy
inhibitors
USP
Specification
Source: M/s Vision
Pharmaceutical
Islamabad
Prilosec
US FDA
ASTRAZENCA
Risek 20 mg
Getz
Pharmaceuticals
(Pvt) Ltd
Losec 20 mg
Barret Hodgson
Pakistan (Pvt)
Ltd
Grant of DML by
way of
formulation
recommended
(25.02.2015).
New License
GOOD
102.
-do-
Uray Capsule
40mg
Each Capsule
Contains
Omeprazole
Enteric coated
pellets (8.5%)
equivalent to
Omeprazole ...40m
g
Proton
pump
inhibitors
USP specification
Source: M/s Vision
Form 5
16-04-2015
(Dy no. 399)
policy
Prilosec
US FDA
ASTRAZENCA
Risek 40 mg
Getz
Pharmaceuticals
(Pvt) Ltd
Losec 40 mg
Barret Hodgson
Pakistan (Pvt)
Ltd
Grant of DML by
56
Pharmaceutical
Islamabad
way of
formulation
recommended
(25.02.2015).
New License
GOOD
103.
-do-
Espo Capsule
20mg
Each Capsule
Contains
Esomeprazole
Form 5
16-04-2015
(Dy no. 398)
Rs. 20,000/-
Enteric coated
pellets (22.5%)
equivalent to
Esomeprazole ...20
mg
As per DRAP
policy
Proton
pump
inhibitors
(USP Spec.s)
Source: M/s Vision
Pharmaceutical
Islamabad
104.
-do-
Nexum 20 mg
Getz
Pharmaceuticals
(Pvt) Ltd
Ezium 20 mg
Searle Pakistan
Ltd
Grant of DML by
way of
formulation
recommended
(25.02.2015).
Espo Capsule
40mg
Each Capsule
Contains
Esomeprazole
Form 5
16-04-2015
(Dy no. 413)
Rs. 20,000/-
Enteric coated
pellets (22.5%)
equivalent to
Esomeprazole ...40
mg
As per DRAP
policy
Proton
pump
inhibitors
(USP Spec.s)
Source: M/s Vision
Pharmaceutical
Islamabad
Nexium
USA FDA
AstraZenca
Nexium
USA FDA
AstraZenca
Nexum 20 mg
Getz
Pharmaceuticals
(Pvt) Ltd
Ezium 20 mg
Searle Pakistan
Ltd
Grant of DML by
way of
formulation
recommended
(25.02.2015).
57
105.
-do-
Prejeb Capsule
75mg
Each Capsule
Contains
Pregabalin ...75mg
Antiepileptic,
Form 5
16-04-2015
(Dy no. 396)
Rs. 20,000/-
Lyrica Capsule
25, 50, 75, 100,
150, 200, 225,
and 300mg)
US FDA
As per DRAP
policy
Gabica
(50,75,100, 150,
and 300mg )
Getz
Pharmaceuticals
(Pvt) Ltd
Zeegap (25,
50,75,100, 150,
mg )
Hilton
Pharmaceuticals
(Pvt) Ltd
Manufacture
specification
Grant of DML by
way of
formulation
recommended
(25.02.2015).
New License
GOOD
106.
-do-
Prejeb Capsule
100mg
Each Capsule
Contains
Pregabalin ...100m
g
Antiepileptic,
Manufacture
specification
Form 5
16-04-2015
(Dy no. 417)
Rs. 20,000/-
Lyrica Capsule
25, 50, 75, 100,
150, 200, 225,
and 300mg)
US FDA
As per DRAP
policy
Gabica
(50,75,100, 150,
and 300mg )
Getz
Pharmaceuticals
(Pvt) Ltd
Zeegap (25,
50,75,100, 150,
mg )
Hilton
58
Pharmaceuticals
(Pvt) Ltd
Grant of DML by
way of
formulation
recommended
(25.02.2015).
New License
GOOD
107.
-do-
MAXSURE
Capsule 0.4mg
Each Capsule
Contains :Tamsulosin HCl as
SR pellets eq. to
Tamsulosin
0.4mg
Form 5
16-04-2015
(Dy no. 404)
policy
Flomax
USA Boehringer
Ingelheim
Pharmaceuticals,
Inc
Tamsolin
Getz pharma
Maxflow
CCL
Alpha -1
Antagonist,
antineoplastic
Grant of DML by
way of
formulation
recommended
(25.02.2015).
(Manufacturers
Spec.s)
Source: M/s Vision
Pharmaceutical
Islamabad
New License
GOOD
108.
-do-
Flupine Capsule
25/12mg
Each Capsule
Contains :Fluoxetine (as
Hydrochloride)
.25mg
Form 5
16-04-2015
(Dy no. 404)
policy
Symbyax
USA Lilly
Olanco
(Genome
Pharma)
Grant of DML by
way of
formulation
recommended
59
Olanzapine ...12mg
(25.02.2015).
Antipsychotic and
a selective
serotonin reuptake
inhibitor
New License
GOOD
(USP specification)
109.
-do-
ZIDOR Capsule
250mg
Each Capsule
Contains
Azithromycin (as
dihydrate)
.250mg
Form 5
16-04-2015
(Dy no. 405)
policy
Antibiotic macrolid
Azasite Capsule
UNITED STATE
INSPIRE
PHARMACEUT
ICALS
Zetro 250mg
Getz pharma
Zitamax 250mg
Pfizer
Laboratories
USP specification
Grant of DML by
way of
formulation
recommended
(25.02.2015).
110.
-do-
Wintek 125mg /
5ml
Dry
No. F-I- 38/2011 Suspension
Lic (M-239
Each 5ml Contains
dated 25-02Clarithromycin
2015)
(USP) 125 mg
Grant
New Macrolide
Antibiotic
DML
Dry Suspension
Section
(USP specification)
Source: M/s Vision
Pharmaceutical
Islamabad
Form 5
16-04-2015
(Dy no. 421)
Rs. 20,000/-
KLACIPED
125mg/5ml
D/Susp.
Abbott SWITZERLAND
As per DRAP
policy
Claritek
125mg/5ml
D/Susp
Getz
Pharmaceuticals
Pvt Ltd
Grant of DML by
way of
formulation
recommended
(25.02.2015).
60
111.
-do-
Wintek 250mg /
5ml
Dry
Suspension
Each 5ml Contains
Clarithromycin
(USP) 250 mg
Macrolide
Antibiotic
Form 5
16-04-2015
(Dy no. 395)
Rs. 20,000/-
KLACIPED
125mg/5ml
D/Susp.
Abbott SWITZERLAND
As per DRAP
policy
Claritek
125mg/5ml
D/Susp
Getz
Pharmaceuticals
Pvt Ltd
(USP specification)
Source: M/s Vision
Pharmaceutical
Islamabad
Grant of DML by
way of
formulation
recommended
(25.02.2015).
New License
GOOD
112.
-do-
ZIDOR 200mg /
5ml Suspension
Each 5ml Contains
Azithromycin (as
dihydrate ) USP
.200mg
Form 5
16-04-2015
(Dy no. 406)
policy
Antibiotic macrolid
USP specification
Zithromax
200mg/5ml
D/Susp.
Pfizer Inc, USA
Zygrel
200mg/5ml
D/Susp
Searle
Pharmaceuticals
Pvt Ltd
Grant of DML by
way of
formulation
recommended
(25.02.2015).
113.
-do-
Linxo 100 mg/5 ml

Dry Suspension
Each 5 ml
Contains: Linezolid
100 mg
Form 5
16-04-2015
(Dy no. 393)
Rs. 20,000/-
BNF: Zyvox
(Pharmacia)
As per DRAP
policy
Grant of DML by
way of
Nezocin
(Brookes)
61
Antibacterial
formulation
recommended
(25.02.2015).
Manufacture
specification
114.
115.
-do-
-do-
Kid-H2 40mg/5ml
Dry Suspension
Each
5
ml
Contains:
Famotidine 40
mg.
(H2
receptor
Blocker. Antipeptic
Ulcerate)
USP Specification
Deslo Syrup
0.5mg/ml
No. F-I- 38/2011

Lic (M-239
Each ml Contains:
dated 25-02Desloratadine ..
2015)
.0.5mg
Syrup Section
Antihistamine
Form 5
16-04-2015
(Dy no. 407)
policy
ZEPSIN40mg/5
ml Dry
Suspension
Cirn Pharma Pvt
Ltd
Form 5
16-04-2015
(Dy no. 408)
policy
Manufacture
Specification
116.
-do-
W-Malt Syrup 50
mg/5ml
Each 5ml Contains:
Iron III Hydroxide
Polymaltose
Complex
equivalent to
elemental Iron50
mg
PEPCID
40mg/5ml Dry
Suspension
Salix
Pharmaceuticals
USA
Form 5
16-04-2015
(Dy no. 394)
policy

Assay of active raw
material.
(Ref: BP, USP)
Firm has submitted an
undertaking that they will
purchase before production
of product.
Grant of DML by
way of
formulation
recommended
(25.02.2015).
Clarinex
0.5mg/ml, Syrup,
FDA
Desora 0.5mg/ml
Syrup,
Continental
Pharma
Grant of DML by
way of
formulation
recommended
(25.02.2015).
Iron preparation
(Approved by
DRB in M-245)
FEROSOFT
(HILTON
PHARMA (PVT)
LIMITED)
Grant of DML by
way of
62
Anti - anemic
117.
-do-
Manufacture
Specification
Wincuss Syrup
800mg/15 ml
Each 15ml
Contains: Iron
protein succinylate
Equivalent to Iron
40mg
formulation
recommended
(25.02.2015).
Form 5
16-04-2015
(Dy no. 420)
policy
118.
-do-
Each 5ml Contains:
Form 5
16-04-2015
(Dy no. 418)
Rs. 20,000/-
Pizotifen as
hydrogen
malate ...0.25mg
As per DRAP
policy
Serotonin and
Histamine
Antagonist
-do-
WINZIC
20mg/5ml
BNF:
Sanomigrane
Elixir Syrup
0.25mg /5ml
Novartis UK
Mosegor Syrup
0.25mg /5ml
Novartis Pharma

Assay of active raw
material.
(Ref: BP)
Firm has submitted an
undertaking that they will
purchase before production
of product.
Grant of DML by
way of
formulation
recommended
(25.02.2015).
Manufacture
Specification
119.
Emico
(Nova Hemis)
Grant of DML by
way of
formulation
recommended
(25.02.2015).
Anti-Anaemic
Haemantinic
Manufacture
Specification
Zofen Syrup
0.25mg/5ml
Iron preparation
approved in
meeting 245.
Syrup
Each 5ml Contains:

Zinc
Sulphate
Monohydrate
equivalent
to
Elemental Zinc
20mg
Zinc Supplement
Form 5
16-04-2015
(Dy no. 402)
policy
Not found in
SRAs
1.Formulation is under review.
Zincat oral
solution of Atco
Labs Karachi
Grant of DML by
way of
formulation
recommended
(25.02.2015).
63
Manufacture
Specification
120.
-do-
Ibofen Syrup
100mg/5ml
Each 5ml Contains:
Ibuprofen
.100mg
Analgesic,
antipyretic,
(NSAID)
Form 5
16-04-2015
(Dy no. 400)
policy
(BP Specification)
121.
-do-
Gesecon syrup
Each 10 ml
contains : Sodium
Alginate (B.P)
1000mg
Potassium
Bicarbonate (B.P)
..200 mg
Form 5
16-04-2015
(Dy no. 414)
policy
Anadine
Suspension
100mg/5ml
Pfizer UK
Brufen
Suspension
100mg/5ml
Abbott
Laboratories
Grant of DML by
way of
formulation
recommended
(25.02.2015).
Gaviscon
Advance
Suspention.
Reckitt Benckiser
Health care
Limited. United
Kingdom
Gviscon Advance
Suspention.
Reckitt Benckiser
(Antacid)
1.Atomic
abosorption
spectrometer is required for
the
determination
of
calcium in API.
2.Atomic
emission
spectrometer is required for
the
determination
of
minerals in compound
alginate suspensions.
(Ref: BP)
Grant of DML by
way of
formulation
recommended
(25.02.2015).
Manufacture
Specification
NEW LICENSE (Veterinary)

Evaluator III
Sr.
#
Name and
Address of
Manufactu
rer/Applic
ant
Brand Name (Proprietary

name+ Dosage form +
Strength) Composition
Pharmacological Group
Finished product
Type of Form
initial date,
diary, fee
including
differential fee
International
status in
stringeqnt
regulatory
agencies Me-too
Remarks/
Observations
64
122. Bio-Oxime
Pharmaceut
icals
Faisalabad
Veterinary
Oral Liquid
(General)
Lic Letter
No. F.1-15/
2013 (Lic)
dated 0304-15
specification
demanded
price/pack size
BIOZAN+ Oral Liqud
Form 5
Each ml contain
Levamisole HCL
B.P.15mg
Oxyclozanide B.P .Vet.30
mg
Sodium Selenite
B.P.Vet.3.4 mg
Cobalt Chloride B.P.7.6
mg
10-04-2015
Rs.20,000/(Dy.No.(2516 )
(Anthelmintic / Dewormer)
Price
Decontrolled/
Pack size
30,50,100 ,
150,250,300,450
, 500l and 1000 ,
2500,5000ml
Manufacture
123. -do-
C-FLOR Oral Liquid
Form 5
Each 1000ml Contains:

Florfenicol..230 gm
Colistin Sulphate
50MIU
10-04-2015
Rs.20,000/(Dy.No. (2520)
(Antibiotic/Antibacterial)
Manufacturer
status GMP
status as depicted
in inspection
report (dated)
Sparanil Reg No
023485
By Sanna
Laboratories
Faisalabad
Inspection of the
firm was carried
out o 26-02-15 by
the pane of
inspectors and
recommended the
grant of DML by
the way of
formulation of
sections namely:
1. Veterinary Oral
Liquid General
2. Veterinary oral
powder general
Maxi Flor Plus
( Reg No 075617)
M/s Biogen
Pharmaceuticals
Price
Decontrolled
Pack size
30,50,100 ,
150,250,300,450
, 500l and 1000 ,
2500,5000ml
65
124. -do-
OXFENDANID PLUS
Oral Liquid
Each ml contain
Oxfendazole .22.65mg
Oxyclozanide ..62.5mg
Manufacturer
125. -do-
SULPHACURE Oral Liquid

Each ml contains
Sulphadiazine..35.500mg
Sulphadmidine
28.400mg
Neomycin
Sulphate..1.800mg
Hyoscine Methylbromide
0.040mg
Pectin7.100mg
Kaolin103.300mg
Vitamin B10.150mg
Vitamin B2..0.220mg
Form 5
10-04-2015
Rs.20,000/(Dy.No. (2522)
Price
Decontrolled
Pack size
30,50,100 ,
150,250,300,450
, 500l and 1000 ,
2500,5000ml
Form 5
10-04-2015
Rs.20,000/(Dy.No. (2518)
Oxanid
Reg No
025745
By Hilton Pharma
Karachi
Sulphacare
Reg No.
041219
By A&K
Pharmaceuticals
Faisalabad
Price
Decontrolled/
30,50,100 ,
150,250,300,450
, 500l and 1000 ,
2500,5000ml
(Antbacterial/Antibiotic)
126. -do-
Manufacturer
BIONID PLUS Oral Liquid
Each 100 ml contains
Oxfendazole (vet)
..2.265gm
Oxyclozanide ..6.25
gm
Cobalt chloride B.P
0.167gm
Sodium Selenite B.P
50mg
Form 5
10-04-2015
Rs.20,000/(Dy.No. (2519)
Closafen SC By
Leads Pharma
Leads Pharma
Reg no 058838
Price
Decontrolled/
Pack size
30,50,100 ,
150,250,300,450
, 500l and 1000 ,
2500,5000ml
Manufacturer
127. -do-
BI-OX PLUS Oral Liquid
Form 5
Each 100ml contains.

Oxfendazole .2.265 gm
10-04-2015
Rs.20,000/-
MD-Oxfenda SC
By
West Mount
66
Cobalt Sulphate .3.82 mg

Selenium.0.35 mg
Manufacturer
128. -do-
BIO-GOLD Oral Liquid

Each ml contain:
Enrofloxacin75 mg
Sulphamethoxy Paradiazine
.50mg
Sulphamethazine..50mg
Trimethoprim25mg
129. -do-
Manufacturer
AC-PLUS Oral Liquid
Each 1000ml contain
Enrofloxacin (B.P Vet)
..100gm
Amantadin (B.P)40gm
Colistin Sulphate (BP)
..35gm
Manufacturer
130. -do-
BIODOX PLUS Oral

Liquid
Each 1000ml contain:
Tylosin tartate..100gm
Doxycycline
HCL..200gm
Colisin
Sulphate..500000iu
Bromohexine HCL
50mg
(Dy.No. (2506)
Price
Decontrolled
Pack size
30,50,100 ,
150,250,300,450
, 500l and 1000 ,
2500,5000ml
Form 5
10-04-2015
Rs.20,000/(Dy.No. (2512)
Price
Decontrolled
Pack size
30,50,100 ,
150,250,300,450
, 500l and 1000 ,
2500,5000ml
Form 5
10-04-2015
Rs.20,000/(Dy.No. (2510)
Price
Decontrolled
Pack size
30,50,100 ,
150,250,300,450
, 500l and 1000 ,
2500,5000ml
Form 5
10-04-2015
Rs.20,000/(Dy.No. (2515)
Reg No 063751
Cina TS
By Leads
Pharma
Reg No 031456
Colamin
Attabak
Pharmaceuticals
Reg no 058900
Medidox plus By
Medi Vet
Reg no
078378
Price
Decontrolled
Pack size
30,50,100 ,
150,250,300,450
, 500l and 1000 ,
2500,5000ml
67
131. -do-
Manufacturer
SULPHA PLUS Oral Liquid
Each ml contain
Sulphadiazine.35
mg
Sulphadimadine.36
mg
streptomycin sulphate.7.6
mg
Neomycin sulphate ..1.8
mg
Sodium
Chloride.11.33 mg
calcium
gluconate.2.2 mg
Magnesium sulphate
0.6 mg
Potassium chloride..3.6
mg
Kaolin.103.33 mg
Pectin7.1 mg
Glycine..20.9 mg
Form 5
10-04-2015
Rs.20,000/(Dy.No. (2514)
No-Scour (Reg
No 072673)
By
M/s Nawan
Laboratories
Price
Decontrolled
Pack size
30,50,100 ,
150,250,300,450
, 500l and 1000 ,
2500,5000ml
(Antibacterial/Antibiotic)
132. -do(Veterinary
Oral
Powder
General)
MAnufaturer
CNF-GOLD Oral Powder
Each 1000gm contain:
ChloroTetracycline..40
gm
ChloroTetracycline..40
gm
Neomycin Sulphate
B.P.12 gm
Furaltadone B.p.30 gm
133. -do-
Manufacture
BIO PSB PLUS Oral
Powder
Each kg contains:
Procain Pencillin..12 gm
Zinc Bacitracin B.P.
Vet..52 gm
Streptomycin sulphate B.
P.36 gm eq. to base.
Form 5
10-04-2015
Rs.20,000/(Dy.No. (2517)
CNF 100
Noa Hemis
Pharmaceuticals
Reg No 009594
Price
Decontrolled
Pack Size
5,10, 20,
50,100,250,500,
1000,5000GM
Form 5
10-04-2015
Rs.20,000/(Dy.No. (2521)
PSB 100 Reg No.

013257
by Naw
laboratories
Price
Decontrolled
Pack Size
5,10, 20,
68
(Antibiotic/ Antibacterial)
Manufacturer
134. -do-
ASPERLYTE-C Oral
Powder
Acetylsalicylic Acid (B.P)
67gm
Vitamin C (B.P)
.200gm
Sodium Citrate (B.P)
..7gm
Potassium Chloride (B.P)
..3gm
50,100,250,500,
1000,5kg,
10kg,15kg,20kg,
25kg and 50kg
Form 5
10-04-2015
Rs.20,000/(Dy.No. (2505)
Asper Gold By
D. Marrson
Pharma
Reg No 048174
Price
Decontrolled
Pack Size
5,10, 20,
50,100,250,500,
1000,5000GM
(Analgesic)
135. -do-
Manufacturer
LINCOSPELL Oral Powder
Each 100 gm contain
Spectinomycin8.8 gm
(as spectinomycin HCL
B.P)
Lincomycin.8.8 gm
( as Lincomycin Hcl B.P)
Amoxicillin Trihydrate
B.P..20 gm
Form 5
10-04-2015
Rs.20,000/(Dy.No. (2511)
Price
Decontrolled
Pack Size
5,10, 20,
50,100,250,500,
1000,5000GM
Speclin Plus By
Selmore Agencies
Reg No 017914
136. -do-
Manufacturer
TRIFON Oral Powder
Form 5
Each 1000 gm contains.

Trichlorfon 98 % /
Metrifonate w/w
10-04-2015
Rs.20,000/(Dy.No. (2523)
(Antiparasitic)
Price
Decontrolled
Pack Size
5,10, 20,
50,100,250,500,
1000,5000GM
Form 5
Manufacturer
137. -do-
AMANTYLDOX Oral
Powder
Each 1000ml contain:
10-04-2015
Rs.20,000/-
Ectonil By Leads,
Pharma
063723
Virox TD BY
lead,s PHARMA
Reg no 075777
69
Tylosin B.P (Vet)

..100gm
Colistin sulphate (B.P)
500Miu
Amantidine HCL (B.P)
.40gm
Doxycycline200Gm
Bromohexine.5Gm
(Dy.No. (2508)
Price
Decontrolled
Pack Size
5,10, 20,
50,100,250,500,
1000,5000GM
138. -do-
Manufacturer
DIARRO PLUS Oral
Powder
Each 12 gm contains
Neomycin (USP)..400 mg
Streptomycin sulphate
(USP)400mg
Sulphaguanidine (BP)..4
gm
Kaolin (USP).. 4 gm
Pectin (USP).. 400 mg
Bismuth Subnitrate (USP)
.. 2 gm
Vitamin A Acetate (USP)
80000 IU
Form 5
10-04-2015
Rs.20,000/(Dy.No. (2509)
Diarroban By Star
Laboratories
Reg No 026438
Price
Decontrolled
Pack Size
5,10, 20,
12,60,50,100,25
0,500,1000,5000
GM
139. -do-
Manufacturer
PRE-SB-PLUS Oral Powder
Colistin Sulphate
60MIU
Procaine Pencillin12
gm
Zinc Bacitracin52
gm
Streptomycin sulphate.36
gm
( Equivalent to 28.80gm of
streptomycin Base)
Form 5
10-04-2015
Rs.20,000/(Dy.No. (2504)
Pro-SB-Plus By
Noa Hemis
Pharmaceuticals
Reg no 028508
Price
Decontrolled
Pack Size
5,10, 20,
50,100,250,500,
1000,5kg,
10kg,15kg,20kg,
25kg and 50kg
140. -do-
Manufacturer
AMOXYCOL SUPER Oral
Powder
Form 5
10-04-2015
Vety Moxil C By
Lead,s Pharma
Reg No 019933
70
Each 100 gm contain

Amoxicillin
Trihydrate..15 gm
Colistin sulphate.50
MIU
Manufacturer
Price
Decontrolled
Pack Size
5,10, 20,
50,100,250,500,
1000,5000GM
BIOGEST Oral Powder
Form 5
Each 1000 Gm Contain

Propionic acid calcium (BP)
.250
Propionic acid sodium
(BP.vet)400g
Acetanilide (M.S).150g
Magnesium oxide (BP)
125g
Iron 11 sulphate (BP)
400mg
Zinc sulphate (BP)
100mg
Magnesium suphate (BP)
.200mg
Copper sulphate (BP)
450mg
Cobalt sulphate (BP.vet.C)
.400mg
Sodium Molybdate(M.S)
..100mg
Sodium Chloride(B.P)
20g
10-04-2015
Rs.20,000/(Dy.No. (2507)
Price
Decontrolled
Pack Size
5,10, 20,
50,100,250,500,
1000,5000GM
141. -do-
Rs.20,000/(Dy.No. (2513)
Alvegest By Star
Laboratories
Reg No 008029
(Macro and Micro minerals)

Manufacture
CaseNo.05 : Registration applications of new sections (Human)
71
S/N
Name
and Brand Name
Type of Form
address
of
name
+ Initial
date,
manufacturer / (Proprietary
Dosage Form + Strength) diary
Applicant
Composition
Finished
Specification
142.
M/s Weather Folds

Pharmaceuticals,
Plot No. 69/2,
Phase II, Industrial
Estate Hattar.
International
Remarks
status
in
reference drug
agencies
/
Fee including authorities
differential fee Me-too status
Demanded
product Price / Pack GMP status as
depicted
in
size
latest inspection
report
(with
date) by the
Evaluator
IROTEN Syrup
Zeefe by Phillips
Pharmaceuticals,
Each 15 ml contains:Dy. No: 685 Lagos Nigeria.
Iron
Protein dated
25-03Hemocare by
Succinylate800 mg
2015
Himount
Liquid
Syrup (Iron deficiency)
General: No. F.36/2007-Lic
(M- (Manufactures Spec)
240 dated 06-032015)
Form 5
Rs. 20,000/-
Pharmaceuticals
Karachi.
As
Per Inspection of the
firm was carried
SRO/120 ml.
out on 21-01-15
by the panel of
inspectors and
recommended
thee grant of
additional
sections namely
1) Dry powder
injectable
general
2) Liquid
Injection
general
3) Liquid syrup
general
4) Sachet
general
72
143.
-do-
RANIFOLD Syrup 75 mg
Each 5 ml contains:Ranitidine as HCl.75mg
(Histamine H2 receptor)
Form 5
Silarx
Pharmaceuticals,
Dy. No: 678 Inc Carmel NY.
dated
25-03Renatil Susp by
2015
M/s Neo Medix
Rs. 20,000/-
Pakistan.
USP
144.
-do-
ACICLO Syrup
Each 5 ml contains:Aciclovir..200 mg
(Antiviral)
As Per SRO/60
ml.
Form 5
Acyclovir Oral
Suspension HiDy. No: 683 Tech Pharmacal
dated
25-03- Switzerland.
2015
Cycloz by M/s
Rs. 20,000/-
Highnoon
Laboratories
Pakistan.
BP Spec
145.
-do-
As Per SRO/60
ml.
LIXIFIL Suspension 30mg Form 5
M/s Actavis Mid
Atlantic LLC
Each 5 ml suspension Dy. No: 481 USA.
contains:dated
02-04Fexofast by M/s
Fexofenadine
HCl 2015
Plantium
equivalent
to
Pharmaceuticals
Fexofenadine..30 mg
Rs. 20,000/Ltd, Pakistan.
Antihistamine
146.
-do-
Manufacturer Spec
Keytot Syrup 1mg
Each 5 ml contains:Ketotifen1 mg
As Per SRO/60
ml.
Form 5
APOKETOTIFEN Dy. No: 485 SYR 1MG/5ML

dated
02-04- of Apotex Inc
(Health Canada)
2015
(Antihistamine and mast

cell stabilizer)
Rs. 20,000/(Manufacturer Spec)
Zatofen by M/s
Novartis Pharma
Pakistan.
As Per SRO/60
ml.
73
147.
-do-
PROCTO Syrup 25 mcg

Each 5 ml contains:Procaterol.25 mcg
(B2-adrenergic
agonist)
148.
-do-
receptor
Form 5
Not found in
reference drug
Dy. No: 483 agencies.
dated
02-04Meptin Syrup 25
2015.
mcg/5ml by M/s
Rs. 20,000/-
(Manufacturer Spec)
As Per SRO /
120 ml.
DRACK Syrup 100 mg

Each 5 ml suspension
contains:Dexibuprofen.100 mg
(NSAID)
(Manufacturer Specs)
Form 5
Not found
reference
Dy. No: 682 agencies
dated
25-03Tercica
2015.
suspension of
Rs. 20,000/-
149.
-doSachet General
STRONTIUM Sachet 2g
Each sachet contains:Strontium Ranelate.2gm
(Antiosteoporotic drug)
Otsuka
Pharmaceuticals
Ltd, Pakistan.
Not found in
reference drug
agencies.
(Firm submitted
reference of
Meptin Syrup 25
mcg/5ml by M/s
Otsuka
Pharmaceuticals
Ltd, Hong
Kong.)
Not found
reference
agencies
Sami Pharma
Karachi
As Per SRO /
120 ml.
Form 5
Protelos Sachet
Servier
Dy. No: 494 Laboratories
EMA agency.
dated
12-032015.
Onita Sachet 2g
Rs. 20,000/-
150.
-do-
As Per SRO /
7s.
MONTEFOLD Sachet 4mg Form 5
Montelukast
Sodium 4 mg
Each sachet contains:Dy. No: 493 Sandoz UK
Montelukast
Sodium dated
12-03Montemax 4 mg
Granules equivalent to 2015.
Sachet of
Montelukast .4 mg
Wnsfeild
Rs. 20,000/Pharmaceuticals
Antihistaminic
As Per SRO /
7s, 14s, 20s,
28s, 30s.
74
151.
152.
-do-
Omefold Sachet
-do-
Each sachet contains:Dy. No: 686

Omeprazole20 mg
dated
25-03Sodium
bicarbonate 2015.
1680mg
Rs. 20,000/(Proton pump inhibitor)
As Per SRO /
7s, 14s, 20s,
28s, 30s.
ACEFOLDS Sachet 200mg Form 5
Each sachet contains:
Acetylcysteine..200 mg
(Expectorant)
Form 5
Zegrid of
Santarus Inc.
Risek Insta by
M/s Getz
Pharmaceuticals
Not found in
reference
dated
12-03Mucolator Sachet
2015.
of Abbott
Rs. 20,000/-
Laboratories
(Pakistan)
Limited.
As Per SRO /
30s.
153.
-doDry Powder
Injection General
Approval
reference as above
154.
-do-
ESOLD Injection 40 mg
Not found in
reference
agencies
(Firm submitted
that formulation
is approved by
the ANSM
France
(ACETYLCYST
EINE 200mg
sachet of Biogran
France)
Form 5
Nexium by M/s
Astra Zeneca UK
Each
vial
contains:- Dy. No: 506 Limited.
Esomeprazole
sodium dated
12-03Esso-40 by
Powder
eq.to 2015.
Shaigan
Esomeprazole40 mg
Pharmaceuticals.
Rs. 20,000/(Proton Pump inhibitor)
As Per SRO
/Vial.
THIAZA 500 mg Injection
Form 5
Azithromycin by
M/s Fresenius
Each
vial
contains:- Dy. No: 505 Kabi USA.
Azithromycin500 mg
dated
12-03Azimycin by M/s
2015.
Mediceena
(Anti-infective drugs)
Pharma (PVT)
Rs. 20,000/Ltd.
As Per SRO
/Vial.
75
155.
-do-
156.
-do-
157.
-do-
158.
-do-
LANSOLFOLD
40mg
Injection Form 5
Prevacid by M/s
TAP
Dy. No: 504 Pharmaceuticals
USA.
Each
vial
contains:- dated
12-03Lansoprazole sodium eq to 2015.
QPRO by M/s
Lansoprazole 40 mg
Bosch
Rs. 20,000/Pharmaceuticals
Pakistan.
(Proton Pump inhibitor)
As Per SRO
/Vial.
PANTOFOLD
Injection Form 5
Sandoz Limited
UK.
40mg
12-03-2015
Panazole by M/s
Each vial contains:Mediate
Pantoprazole sodium eq to Rs. 20,000/Pharmaceuticals
Pantoprazole 40 mg
Pakistan.
As Per SRO
/Vial.
OMEP Injection 40mg
Form 5
Rs. 20,000/-
As Per SRO
/Vial.
Form 5
Klaricid IV 500
mg by Abbott
Dy. No: 507 UK.
dated
12-03Klaricid by M/s
2015.
Abbott Pakistan.
Losec by
AstraZeneca UK
Each vial contains:Dy. No: 508 Limited.
Omeprazole sodium eq to dated
12-03Omega by M/s
Omeprazole 40
2015.
Ferozsons
CINFOLD Injection 500mg

Each vial contains:Clarithromycin.500 mg
(Macrolide)
Laboratories
Pakistan.
Rs. 20,000/(Manufacturer Specs)

As Per SRO
/Vial.
76
159.
-doLiquid Injection
Ampoule General
Approval
reference as above
VITA-3 Injection
Form 5
Not found in
reference
Each
1ml
ampoule Dy. No: 499 agencies
contains:dated
12-03Vital D by M/s
Cholecalciferol200,000 I.U 2015.
Macter
eq. to Colecalciferol.5
International
mg
Rs. 20,000/Pakistan.
(Vitamin D3)
160.
161.
-do-
-do-
As Per SRO /
1mlx1s,
(Manufacturer specs)
5x1ml.
BALMINE injection 500 Form 5
mcg
Dy. No: 495 Amcobal by M/s
Each ml contains:dated
12-03- Amson Pharma
Pakistan.
Mecobalamine.500 mcg
2015.
Not found in
reference
agencies
(Coenzyme-type Vit B12)
Rs. 20,000/-
As Per SRO /
1mlx10s.
Form 5
WHO
recommended
Dy. No: 502 formulation
dated
12-03Artem by M/s
2015.
Hilton Pharma
Wenomet Injection 80mg

Each 1ml contains:Artemether80 mg
(Ant malarial)
Rs. 20,000/-
Formulation is
approved in the
previous
meetings as
included in JP.
Deferred in
previous board
meeting for
recommendation
of Malaria
control program
Pakistan.
162.
-do-
As Per SRO /
1ml.
NOVOFER Injection
Form 5
Venofer by M/s
Vifor Pharma UK
Each 5 ml contains:Dy. No: 501 limited.
Iron Sucrose Complex eq. dated
12-03Irovit by M/s
to Iron (element).100 mg 2015.
Hansel
(Antianeamic)
Rs. 20,000/-
As Per SRO /
5mlx5s.
Pharmaceuticals
Pakistan.
77
163.
164.
-do-
DANFOLD Injection 8mg
-do-
Each 4 ml ampoule Dy. No: 727

contains:dated
26-03Ondansetron (as
HCl) 2015.
.8mg
Rs. 20,000/(Serotonin 5-HT3 receptor
antagonist)
As Per SRO /
1x1s
USP Specs
1x4s.
Lignofold Injection 1%
Form 5
Each ml ampoule contains:Lignocaine HCl10mg
(Local Anesthetic)
Form 5
Zofran by GSK
UK
Ondansetron by
M/s Novartis
Pharma Pakistan.
Lidocaine
Injection of
Dy. No: 725 Hospira
dated
26-03- (USFDA)
2015.
Epocain of
Rs. 20,000/-
Epoch Karachi
BP
165.
-do-
TROLDS Injection 30mg
As Per SRO /
2mlx1s
2mlx4s.
Form 5
Each ml contains:Dy. No: 498

Ketorolac Trometamol eq. dated
12-03to Ketorolac.30 mg
2015.
166.
M/s Genome
Pharmaceutical
(Pvt.) Limited,
S.I.T.E.
16/I, Phase IV,
Industrial Estate
Hattar Pakistan
(Sachet General)
Letter No. F.37/95-Lic (Vol-I)
dated 07-04-15
Toradol
(Roche)
Toradol
(Martin Dow)
(NSAID)
Rs. 20,000/-
USP Specs
As Per SRO /
1x1s, 1x4s.
Form 5
Not found in
reference
Dy No. 166
agencies.
dated
10.03.2015
Mucolator
(Abbott
20000/Laboratories)
BRONCHS 200mg Sachet

Acetylcysteine.200mg
(Mucolytic Agent)
As per SRO/
30s
Inspection of the
firm was carried
out on 10-04-15
by the area FID
by nothing was
reported in
Not found in
reference
agencies.
(Firm claimed
that the product is
available in
South Africa and
Switzerland.
Solmucol sachet
(South Africa)
Fluimucil
(Switzerland)
78
violation of
GMP.
167.
-do-
CALRENE 5g Sachet
Form 5

Calcium polystyrene
Sulfonate.5g
Dy No. 166
dated
10.03.2015
(Serum potassium level

lowering agent)
20000/-
As per SRO/Pack of 30s
Not found in
reference
agencies
Kalimate
Of Maple
Pharmaceuticals (
needs
confirmation
Firm submitted
that the product is
available in Japan
(Kalimate
(Nikken
Chemicals Co.,
Ltd., Japan).
However, this
drug was not
found on PMDA
database.
Registration
Board in 247th
discussed expert
opinions in detail
and agreed to
these opinions for
grant of
registration. Firm
will import
Calcium
Polystyrene
Sulfonate from
M/s Kowa
Company Ltd,
Japan and
repacking and
quality control
release will be
done at M/s
Maple
Pharmaceuticals
(Pvt.) Ltd,
Karachi.
Registration
Board advised
the firm to
provide legalized
GMP of Kowa
Company Ltd,
79
Japan and
stability data for
consideration of
Registration
Board.
168.
-do-
COLONIL Fibro Sachet
Form 5

Mebeverine
HCl.135mg
Ispaghula Husk.3.5g
Dy No. 158
dated
09.03.2015
Fybogel
Mebeverine
(Reckitt
Benckiser
Healthcare (UK)
Limited)
20000/(Antispasmodic +
Laxative)
169.
-do-
GENOCOL Sachet
Polyethylene glycol 3350
13.125g
Sodium
chloride...0.3507g
Sodium
bicarbonate..0.1785g
Potassium chloride
0.0466g
As per SRO/
Pack of 10s
Form 5
Dy No. 158
dated
09.03.2015
Colospas Fibro
of Nabiqasim
Industries
Movicol Sachet
(Norgine
Limited, New
Road, Hengoed,
Mid Glamorgan,
CF82 8SJ UK)
20000/As per SRO/Pack of 10s
Movcol
(Genix Pharma)
(Laxative + Electrolyte
balance)
170.
-do-
MEKAST Pediatric 4mg
Sachet
Montelukast
(as sodium).4mg
Form 5
Dy No. 159
dated
09.03.2015
20000/-
(Leukotriene receptor
antagonist)
Singulair
Paediatric Sachet
(Merck & Co.,
Singulair
Paediatric
(OBS Pakistan)
As per SRO/10s
(Genomes specs)
80
171.
-do-
REHYD-R Sachet
Form 5
Dy No. 161
dated
09.03.2015
Rice powder......6g
Sodium
chloride.0.350g
Potassium
chloride...0.300g
Sodium
citrate....0.580g
20000/-
Dioralyte Relief
Blackcurrant
Sachets
(Aventis Pharma
Limited, UK)
Hilyte-R
(Hilton Pharma)
As per SRO/Pack of 10s
(ORS)
172.
-do-
STRON-ATE 2g Sachet
Strontium Ranelate.2g
Form 5
Dy No. 157
dated
09.03.2015
(Treatment of osteoporosis)
Protelos Sachet
(Serveir) BNF
Onita
(PharmEvo)
20000/(Manufacturer specs)
173.
-do-
GenoIU granules Sachet

L-lysine HCl
L-methionine
L-isoleucine
L-leucine
Lphenylalanine
L-threonine
L-tryptophan
L-valine
L-histidine
HCl
291mg
320.3mg
203.9mg
320.3mg
320.3mg
145.7mg
72.9mg
233mg
216.2mg
As per SRO/pack of 7s
Form 5D
Dy No. 164
dated
09.03.2015
50000/As per SRO/Pack of 100s
Not found in
reference
agencies.
a. Firm submitted
that the product
is available in
Japan (GenoIU
granules Sachet
of Ajinomoto
Pharmaceutical
s Tokyo, Japan)
this needs
confirmation.
b. Stability data
needs to be
submitted.
c. Clinical trial data
is not
submitted.
(Amino acids)
81
174.
-do-
BARIO VU Sachet (13%

w/v)
Each sachet:
100gm powder contains
barium
sulphate..81gm
X-ray contrast media
Manufacturer
175.
176.
-do-
Rasco pharma5.5
Km Near Ali Raza
Abad, Holiday
Park Plot No.27
Raiwind Road
Lahore, Pakistan
RACE INFANTS Sachet

10mg
Form-5D
Dy No 3091
dated : 30-042015
50000/As
recommended
by MOH/ pack
of 12s
Form 5D

Racecadotril.10mg
Dy No.
dated
10.04.2015
Antidiarrhoeal
50000/-
As per SRO/pack of 16s

Form-5
RASCODOL-LA Injection
Each 2ml contains:
Paracetamol BP300mg
Lignocaine.10mg
Dy No: 2814
dated 17-04-15
20,000/-
(Analgesic antipyretic)
Liquid Injection
Ampoule General
Manufacturers
As per SRO
2ml 10s
Hidrasec sachets
of Bioprojet UK
(MHRA )
Not found in
reference
agencies
Pracan injection
(Nexus Pharma
Karachi)
Firm submitted
that product is
available in
Canada but has
not been verified
from reference
agencies.
Stability data
needs to be
submitted
Clinical trial data
is not provided.
439.
Stability
data needs to
be submitted.
Firm submitted
that the product is
available in India
(Aeknil
Therapeutic
Pharmaceuticals
India)
Inspection of the
firm was
conducted by the
panel of
inspectors on
dated 29-01-15
and
recommended the
grant of
additional section
i.e. liquid
Injectable
ampoule general
( filling of one
dosage form i.e.
ampoule and vial
at one time)
82
177.
178.
-do-
-do-
SUCRAS Injection
Form-5
Each 5ml ampoule

contains:
Iron(III) hydroxide sucrose
complex eq. to elemental
iron USP. 100mg
Dy No: 2816
dated 17-04-15
(Iron supplement)
As per SRO
5ml 5s
Manufacturers
MEGALOB injection
500mcg
Form-5
180.
181.
-do-
-do-
-do-
Rubiject injection
(AGP) Karachi.
20,000/-
Dy No: 2821
dated 17-04-15
Methycobal
injection
Eisai Co Ltd
(Japan)
(Vit.B12 substance)
20,000/As per SRO

1ml 10s
Mabil injection
(Sami Pharma
Karachi)
Manufacturers
ANAC Injection
Form-5
Voltral Injection
Novartis USA.
Each 1ml ampoule

contains:
Mecobalamine..500mcg
179.
Venofer injection
Syner Med USA
Each 3ml ampoule

contains:
Diclofenac Sodium
BP.75mg
Dy No: 2815
dated 17-04-15
(NSAID)
As per SRO
3ml 5s
20,000/-
Manufacturers
IXALT injection 80mg
Form-5
Each 1ml ampoule

contains:
Artemether..80mg
Dy No: 2818
dated
17.4.2015
(Antimalarial)
20,000/As per SRO

1ml 6s
Form-5
Manufacturer
RASVIL Injection
Each 2ml ampoule
contains:
Pheniramine
Maleate..25mg
Dy No: 2812
dated
17.4.2015
Dicloran
injection
(sami pharma
Karachi)
WHO
recommended
formulation
Indomal injection
(Indus pharma)
Not found in
reference
agencies
Avil of Sanofi
Karachi
Formulation is
deferred in
previous
meetings for
recommendations
of malaria control
program.
Not found in
reference
agencies
(Firm submitted
that the product
os available in
83
20,000/-
Australia (Avil
Sanofi aventis
Australia)
(Antihistamine)
182.
183.
-do-
-do-
Manufacturers
REVINATE Injection 50mg
Each 1ml ampoule
contains:
Dimenhydrinate
USP.50mg
(Antihistamine)
USP
Specifications
TROMOL Injection 30mg
185.
-do-
-do-
Dy No: 2812
dated
17.4.2015
20,000/As per SRO
1ml 25s
Form-5
Dimenhydrinate
injection of
Fresenius Kabi
(USFDA)
Gravinate
injection
(Searle pharma)
Dy No: 2818
dated
17.4.2015
Ketorolac
Tromethamine
Injection of
Hospira
(USFDA)
(Non-Opoid Analgesic)
20,000/-
Toradol injection
(Martin Dow)
USP Specifications
As per SRO
1ml 5s
CALCIROL Injection 5mg
Form-5
Each 1ml ampoule

contains:
Colecalciferol BP5mg
(200,000IU)
Dy No: 2817
dated
17.4.2015
(Vitamin-D Analogue)
20,000/-
BP Specifications
As per SRO
1ml 1s
TOMDOL Injection 100mg
Form-5
Each 2ml ampoule

contains: Tramadol HCl
BP.100mg
Dy No: 2818
dated
17.4.2015
Inspection Report
Dated:
(3.6.2014)
Tramadol
Injection of
Beacon
Pharmaceuticals
UK (MHRA)
20,000/-
Tonoflex
injection
Each 1ml ampoule

contains:
Ketorolac Tromethamine
USP..30mg
184.
As per SRO
2ml 100s
Form-5
(Opoid Analgesic)
Inspection Report
Dated:
(3.6.2014)
Not found in
reference
agencies
Indrop D
injection
(Neutro
Pharma)Lhr
Not found in
reference
agencies
(Firm submitted
that the product is
available in UK
(D3-vicotrat
Heyl ChemPharma UK)
84
Manufacturers
As per SRO
2ml 5s
(Sami Pharma
Karachi)
M/s Vision Pharmaceuticals, Plot no 22-23, industrial triangle Kahuta road Islamabad with DML
No: 517, has applied for the registrations of following additional sections which are approved in
240th meeting of CLB.
1.
2.
3.
4.
5.
6.
Tablet (general)
Capsule (general)
Small volume parenterals (blow fill and seal technology)
Oral dry powder suspension (general)
Sterile dry powder Injectable (general)
Sachet (general)
During securitization it is observed the firm had the manufacturing premises with the same above
mentioned DML at I-10 industrial area Islamabad. In this context PEC has requested, R-IV
section and Licensing division, to provide the details of registrations granted to M/s Vision
Pharmaceuticals Islamabad in past and valid as of today and for the clarification whether the
above mentioned sections are transferred from 1-10 industrial area Islamabad to the Plot no 2223, industrial triangle Kahuta road Islamabad or above mentioned sections are new addition to
their manufacturing facility, respectively.
S/N
Name
and Brand Name
Type of Form
address
of
name
+ Initial
date,
Applicant
Composition
Finished
Specification
186.
International
Remarks
status
in
reference drug
agencies
/
Demanded
depicted
in
size
latest inspection
report
(with
date) by the
Evaluator
M/s
Vision MUCONIL 225 mg sachets
Pharmaceuticals
Plot #: 22-23, Each Sachet Contains:Industrial Triangle Erdosteine225 mg
Kahuta
Road,
Form 5
Not found in
reference
Dy
No.2030 agencies
dated 19-03-15 Dostin of
International
availability in
reference
agencies need to
85
187.
IslamabadMucolytic.
Pakistan
(Sachet Section)
Manufacturer
General: No F.126/2009-Lic dated
03april 2015
-doMONTEL Sachets 4 mg
Each Sachet Contains:Montelukast (as Sodium)
4.00 mg
Leukotriene receptor
antagonist
Rs. 20,000/-
Brookes
submitted.
As Per SRO/
pack of 5s
Form 5
SINGULAIR of
MERCK
Dy
No.2069 (USFDA)
dated 19-03-15
Montemax 4 mg
Sachet of
Rs. 20,000/Wnsfeild
As Per SRO/ Pharmaceuticals
pack of 14s
188.
-do-
Manufacturer
Diarosec 10 mg sachet
Each Sachet Contains:Racecadotril (Granules)
..10 mg
Form 5
HIDRASEC
Evidence of local
10mg
Sachet availability is not
Dy
No.2063 (MHRA)
provided by the
dated 19-03-15
firm.
Me too status is
Rs. 20,000/not submitted.
Antidiarrhoeal
189.
-do-
Manufacturer
Diarosec 30 mg sachet
Each Sachet Contains:Racecadotril (Granules)
..30 mg
As Per SRO/
pack of 10s
Form 5
HIDRASEC
30mg
Sachet
Dy
No.2021 (MHRA)
dated 19-03-15
Me too status is
Rs. 20,000/not submitted.
Evidence of local
availability is not
provided by the
firm.
Antidiarrhoeal
190.
-do-
Manufacturer
SODACITRO sachets
Each Sachet Contains:Sodium
Bicarbonate..1.716 gram
Sodium Citrate..0.613
gram
Citric Acid0.702
gram
Tartaric Acid0.856
gram
As Per SRO/
pack of 10s
Form 5
Not found in
reference
Dy
No.1908 agencies
dated 19-03-15
Citrosoda of
Rs. 20,000/Abbott Labs
International
availability in
reference
agencies need to
be submitted.
As Per SRO/
pack of 100s
86
granular Sugar..113.00
mg
Gastric antacid and urinary
alkalinizing agent)
191.
192.
-do-
-do-
Manufacturer
OSTEONIL sachets 2 g
Form 5
Each Sachet Contains:Strontium Ranelate2g
Dy
No.2374
dated 19-03-15
(Antiosteoporotic drug)
Rs. 20,000/-
Manufacturer
As Per SRO/
pack of 7s
Form 5
Fybogel
Mebeverine
Dy No. 3234
(Reckitt
dated
Benckiser
08.05.2015
Healthcare (UK)
Limited)
20000/Colospas Fibro
of Nabiqasim
As per SRO/
Industries
Pack of 10 &
30s
Form 5
Movicol Sachet
(Norgine
Dy No. 3237
Limited, New
dated
Road, Hengoed,
08.05.2015
Mid Glamorgan,
CF82 8SJ UK)
20000/Movcol
As per SRO/(Genix Pharma)
Pack of 10s
FIBOVIR Sachet
Mebeverine
HCl.135mg
Ispaghula Husk.3.5g
(Antispasmodic +
Laxative)
Manufacturer
193.
-do-
MACROLEX Sachet
Polyethylene glycol 3350
13.125g
Sodium
chloride...0.3507g
Sodium
bicarbonate..0.1785g
Potassium chloride
0.0466g
Protelos Sachet
(Serveir) BNF
Onita
(PharmEvo)
(Laxative + Electrolyte
balance)
194.
Sterile Dry
Powder Injectable
Vials (General)
Manufacturer
DEFROX injection 500mg
Form 5
Each Vial Contains:-
Dy
Deferoxamine
mesylate for
No.2040 Injection
87
Letter. No F.126/2009-Lic Dated

03april 2015
Deferoxamine mesylate
dated 19-03-15
Lyophilized Powder
500mg
Rs. 20,000/(Iron Chelating agent)
195.
-do-
196.
197.
198.
-do-
Small Volume
Prenteral (Blow
Fill & Seal
Teachnology)
General: No F.126/2009-Lic
Dated 03-04-2015
-do-
USP
ECLARICIN
Injection500mg
As Per SRO/
pack of 1s
USA
Hospira
Desferal of
Novartis
Form 5
Clarithromycin
500mg Powder
Dy
No.1911 Arcolab
dated 19-03-15 International
Limited(MHRA)
Each Vial Contains:Clarithromycin

(Lyophilized
powder) Rs. 20,000/B.P500mg
Macrolide- Anti-Infective
As Per SRO/
pack of 1s
BP
OSTONATE
Injection Form 5
90mg
Dy
No.2375
Each Vial Contains:dated 19-03-15
Pamidronate disodium..
90 mg
Rs. 20,000/Diphosphonate/ Drug
effecting bone metabolism
As Per SRO/
pack of 1s
(B.P)
Dexsol IV Infusion 5%
Form 5
Klaricid of Abbot
Aredia Injection
of Novartis
(USFDA)
Pamidra of AJ
Mirza Karachi
B Braun 5%
Dextrose (FDA)
Each ml contains:Dy
No.2060
Dextrose
Anhydrous dated 19-03-15 Macsol of Mac &
B.P.. 50mg
Rains Lahore
Rs. 20,000/Carbohydrate
caloric
solution
As Per SRO/
pack of 100ml
(B.P)
Dexsol IV Infusion 25%
Form 5
25%
Dextrose
Injection
Each ml Contains:Dy
No.2046 Hospira
Dextrose Anhydrous B.P dated 19-03-15
250mg
25%
Dextrose
Rs. 20,000/Injection
of
Carbohydrate
caloric
Otsuka Pakistan
88
solution
As Per SRO/
pack of 20ml
199.
-do-
(B.P)
VISOLINE
0.9%
200.
-do-
Pcarb IV Infusion 8.4%
201.
-do-
202.
-do-
IV
Infusion Form 5
0.9%
Sodium
Chloride
Dy
No.2046 Injection
Each ml Contains:dated 19-03-15 B. Braun Medical
Sodium
Chloride
Inc. Irvine,
USP..9mg
Rs. 20,000/(USFDA)
Electrolyte
(USP)
As Per SRO/ Plasline
of
pack of 25ml
Otsuka
Form 5
Sodium
Bicarbonate
Each ml Contains:Dy
No.2022 Injection
Sodium
Bicarbonate dated 19-03-15 (USFDA)
B.P.. 84mg
Rs. 20,000/Meylon
of
Electrolyte
Otsuka
As Per SRO/
(B.P)
pack of 25ml
K-SOL IV Infusion
Form 5
Potassium
Contains:chloride injection
Dy
No.2019 of Hospira
Each ml contains:
dated 19-03-15
Potassium
Chloride
Potassium
B.P..74.6 mg
Rs. 20,000/chloride injection
of otsuka
Electrolyte
As Per SRO/
pack of 25ml
(B.P)
ACETAMOL Infusion
Form 5
Perfalgan inf of
BMS
Each 100ml Contains:Dy
No.2019
Paracetamol..1000mg
dated 19-03-15 Provas of Sami
Pharmaceuticals
Antipyretic and analgesic
Rs. 20,000/Karachi
(B.P)
203.
-do-
As Per SRO/
pack of 100ml
Water for Injection
Form 5
Sterile Water For
injection
in
Each
LDPE
ampoule Dy
No.2027 plastic container.
contains:
dated 19-03-15 B.Braun
89
Water for injection..5ml
204.
-do-
205.
-do-
206.
(Capsule General)
NDA 019077
Rs. 20,000/Diluent / a vehicle for

WFI of Zafa
suitable medications
As Per SRO/
pack of 5ml
(USP)
Water for Injection
Form 5
Sterile Water For
injection
in
Each
LDPE
ampoule Dy
contains:
NDA 019077
WFI of Zafa
As Per SRO/
pack of 10ml
(USP)
Water for Injection
Form 5
Sterile Water For
injection
in
Each
LDPE
ampoule Dy
contains:
NDA 019077
WFI of Zafa
As Per SRO/
pack of 20ml
(USP)
DICLOFEN SR 100 mg
Form 5
Rhumalgan XL
100mg modifiedEach Capsule Contains:Dy
No.1913 release capsules
Diclofenac Sodium
dated 19-03-15 of Sandoz UK
(SR as pellets 45%)
Plogin of
.100.00 mg
Rs. 20,000/Brookes
NSAID
As Per SRO/
Pack of 20s
Manufacturer
207.
-do-
Source: M/s Vision Pharma

Islamabad.
MUCONIL Capsules 300 Form 5
mg
Dy
No.2035
Each Capsule Contains:dated 19-03-15
Erdosteine..300mg
Rs. 20,000/-
Erdotin 300 mg
capsules of Galen
UK
Dostin of
90
Mucolytic.
208.
209.
-do-
-do-
Brookes Karachi
As Per SRO/
Manufacturer
Pack of 20s
FLUCONZ Capsules 150 Form 5
mg
Dy
No.2050
Fluconazole..150mg
Rs. 20,000/Triazole Antifungal
As Per SRO/
Manufacturer
Pack of 1s
ICOZOL Capsules 100 mg
Form 5
Diflucan
Capsules
Pfizer.
Diflucan
Pfizer
of
of
Itraconazole caps
of Actavis UK
Each Capsule Contains:Dy

No.2051
Itraconazole IR pellets 22% dated 19-03-15 Sporanox
of
eq.
to
Janssen Cilag
Itraconazole..100mg
Rs. 20,000/(Triazole antifungal)
As Per SRO/
Pack of 4s
Manufacturer
210.
-do-

Islamabad.
NOBESE Capsules
Form 5
Each Capsule Contains:Orlistat immediate release
pellets (50%) eq. to
Orlistat. 120 mg
Dy
No.2025
dated 19-03-15 Obistat of Global
Pharma
Rs. 20,000/-
Lipase Inhibitor
As Per SRO/
Pack
of
10sx20
Manufacturer
211.
-do-
Xenical
(FDA
Approved)

Islamabad.
DIAROSEC capsules 100 Form 5
mg
Dy
No.3233
Rececadotril..100 mg
Rs. 20,000/Antidiarrhoeal
Hidrasec
Evidence of local
capsules( MHRA availability is not
)
submitted by the
firm
Me
too
not
submitted
91
212.
-do-
213.
-do-
As Per SRO/
Manufacturer
Pack of 10s
HYDROXIA
Capsules Form 5
Droxia capsules
500mg
(FDA)
Dy
No.1914
Each Capsule Contains:dated 19-03-15 Hydrea Capsules
HydroxyUrea..500mg
of Gsk
Rs. 20,000/DNA reactive cytotoxic
As Per SRO/
USP
Pack of 100s
ZAP Capsules 40mg
Form 5
Geodon Capsules
of Pfizer
Each capsule contains:
Dy
No.2060
Ziprasidone
as dated 27-03-15 Zapris of English
hydrochloride
Pharma
mnohydarte..40mg
Rs. 20,000/Atypical antipsychotic
214.
-do-
Manufacturer
ZAP Capsules 60mg
Ziprasidone
hydrochloride
mnohydarte..60mg
Atypical antipsychotic
215.
216.
-do-
As Per SRO/
Pack of 10s
Form 5
Geodon Capsules
of Pfizer
Dy
No.2070
as dated 27-03-15 Zapris of English
Pharma
Rs. 20,000/As Per SRO/
Pack of 10s
Manufacturer
CONZI Capsules 50mg
Form 5

Tramadol HCL..50mg
Dy
No.2033
dated 27-03-15
Centrally acting synthetic Rs. 20,000/Opoid analgesic

As Per SRO/
Manufacturer
Pack
of
20x10s
(Oral Dry Powder MALARID Suspension
Form 5
CO-Artesiane
Suspension)
Dafra Pharma
Each 5ml Contains:Dy
No.2020 Beliguim
Artemether 15 mg
dated 19-03-15
92
Lumifantrine90 mg
Rs. 20,000/-
Arceva of Sami
Pharma
Antimalarial
Manufacturer
217.
-do-
AZIVIS Suspension
Each 5ml Contains:Azithromycin (as
Dihydrate) ----200 mg
(Macrolide)
218.
-do-
Manufacturer
CLARIOCIN Suspension
Each 5ml Contains:Clarithromycin
( as Granules 27.5%)------125mg
( Macrolide)
As Per SRO/
Pack of 60ml,
120ml
Form 5
BNF: Zithromax
(Pfizer)
Dy
No.2071
dated 19-03-15 ZETRO of Getz
Pharma (Pvt.) Ltd
Rs. 20,000/Karachi.
As Per SRO/
Pack of 15ml
Form 5
BIAXIN
FOR
SUSPENSION
Dy
No.2048 AbbVie USA
dated 19-03-15
Klaricid
of
Rs. 20,000/Abbott
As Per SRO/
Pack of 60ml
(USP)
219.
-do-

Islamabad.
CINPRO suspension
Not found in
reference
Dy
No.2055 agencies.
dated 19-03-15
Novidat of sami
Pharma ( API is
Rs. 20,000/Ciprofloxacin
HCL)
As Per SRO/
Pack of 60ml
Formulation
is
already in review.

Islamabad.
CINPRO suspension
Form 5
Formulation
under review.
Each 5ml Contains:-
Dy
Each 5ml Contains:Ciprofloxacin base taste

masked pellets 25% eq. to
Ciprofloxacin.125mg
Fluoroquinolone
Form 5
Manufacturer
220.
-do-
CIPRO of Bayer
Health care USA.
No.2055
93
is
Ciprofloxacin base taste

masked pellets 25% eq. to
Ciprofloxacin.250mg
dated 19-03-15
Fluoroquinolone
As Per SRO/
Pack of 60ml
Rs. 20,000/-
Novidat of Sami
Pharma ( API is
Ciprofloxacin
HCL)
Manufacturer
221.
-do-

Islamabad.
MUCONIL Suspension
Each 5ml Contains:Erdosteine..175.00 mg
Mucolytic
Manufacturer
222.
-do-
FOSF Suspension
Each 5ml Contains:Fosfomycin
(as calcium)250 mg
Antibiotic
223.
-do-
Manufacturer
TAWANA suspension
Each 5ml Contains:Ossein mineral complex
400 mg
Vitamin D400IU
Calcium phosphorous
supplement/ vit D
224.
(Tablet General)
Manufacturer
BISOCARD 2.5mg Tablets
Form 5
Not found in
reference
Dy
No.2053 agencies.
dated 19-03-15
Dostin of
Rs. 20,000/Brookes
As Per SRO/
Pack of 100ml
Form 5
Not found in
reference
Dy
No.2047 agencies.
dated 19-03-15
Mefos of
Rs. 20,000/Remington
Pharma
As Per SRO/
Pack of 60ml
Form 5
Not found in
reference
Dy
No.2379 agencies.
dated 19-03-15
Osnate-D of AGP
Rs. 20,000/Karachi
As Per SRO/
Pack of 60ml
International
availability
in
reference
agencies need to
be submitted.
Not found in
reference
agencies.
Not found in
reference
agencies.
Firm claimed that
product
is
available in New
Zeeland
(Ossomer
BY Biomer
Newzealand)
Form 5
BISOPROLOL
2.5
Each film coated Tablet Dy
No.2044 Film
coated
Contains:dated 19-03-15 tablets of Accord
Bisoprolol (as fumarate)
Health care UK
94
-----2.5 mg
Rs. 20,000/Concor of Merck
(Cardio
Blocker)
225.
-do-
226.
-do-
selective
Beta As Per SRO/

Pack of 14s
Manufacturer
BISOCARD 5mg Tablets
BISOPROLOL
2.5
Each film coated Tablet Dy
No.2072 Film
coated
Contains:dated 19-03-15 tablets of Accord
Bisoprolol (as fumarate)
Health care UK
-----5 mg
Rs. 20,000/Concor of Merck
(Cardio selective Beta As Per SRO/
Blocker)
Pack of 14s
Manufacturer
MOXIBACT tablets 400
mg
Each film coated tablet
Contains:
Moxifloxacin
(as Hydrochloride)
..400.00 mg
Quinolone
227.
-do-
Manufacturer
PSUPP XR 10 MEQ tablets
Each Tablet Contains
Potassium Citrate.. (10
MEQ)
(Potassium Supplement)
Manufacturer
228.
-do-
ESONAP 20/375 mg
Tablets
Naproxin .375.00 mg
Esomeprazole..20.00 mg
Form 5
Form 5
Avelox tablets
(FDA)
Dy
No.2059
dated 19-03-15 Avelox of Bayer
Rs. 20,000/As Per SRO/
Pack of 5s
Form 5
Potassium citrate
tablets (FDA)
Dy
No.2031
dated 19-03-15 Urocit-K of
mission
Rs. 20,000/Pharma( not
confirmed)
As Per SRO/
Pack of 30 &
100s
Form 5
VIMOVO tablets
(FDA)
Dy
No.2058
dated 19-03-15 Me too not
provided.
Rs. 20,000/-
Evidence of local
availability need
to be submitted.
95
NSAID/ PPI
229.
-do-
As Per SRO/
Pack of 3x6s
Manufacturer
ESONAP 20/500 mg
Tablets
Naproxin .500 mg
Esomeprazole..20 mg
NSAID/ PPI
230.
231.
-do-
-do-
Form 5
VIMOVO tablets
(FDA)
Dy
No.2032
dated 19-03-15 Me too not
submitted
Rs. 20,000/-
Evidence of local
availability need
to be submitted.
As Per SRO/
Pack of 3x6s
Manufacturer
LYZA Tablet 2.5mg
Form 5

contains:
Saxagliptin as
HCL.2.5mg
Dy
No.2036
dated 27-03-15
DPP4 Enzyme Inhibitor
As Per SRO/
Pack of 20s
Manufacturer
LYZA Tablet 5mg
Rs. 20,000/-
Form 5

contains:
Saxagliptin as HCL.5mg
Dy
No.3235
dated08-05-15
Rs. 20,000/-
Onglyza 2.5 mg
film-coated tablets
of AstraZeneca
Gliplyza of Macter
Karachi
Onglyza 5 mg filmcoated tablets of

AstraZeneca
Gliplyza of Macter
Karachi
DPP4 Enzyme Inhibitor

As Per SRO/
Pack of 14s
Manufacturer
Evaluator II
S/N
Name
and Brand Name
address
of
manufacturer / (Proprietary name
+ Dosage Form +
Applicant
Strength)
Composition
Pharmacological
Group
Type of Form
Initial
diary
International
status in stringent
date, regulatory
agencies
Fee including
differential fee
Me-too status
GMP status as
depicted
in
Demanded
inspection
report
Price / Pack
96
232.
M/s Sami
Pharmaceuticals
(Pvt.) Limited,
F-95, S.I.T.E.
KarachiPakistan
(Oral Liquid
General Section)
233.
M/s Fynk
Pharmaceuticals
, 19 Km G.T.
Road, Kalashah
Kaku, Lahore,
Pakistan.
Cream/Ointment
General: No. F
1-63/84-Lic
Finished
product size
Specification
(dated)
Acebro 10mg/ml
Syrup
Each ml contains:Acebrophylline
10mg
(Manufacturers
Spec.s)
(bronchodilator)
Form 5-D
Rs. 50,000/(07-10-2013)
Not confirmed
Ceda-V 2% Vaginal
Cream
Contains:Clindamycin (as
Phosphate U.S.P.)
2.0%w/w
(Lincosamide
Antibacterial)
(U.S.P.
Form 5
R&I 1128, 0307-2014
Rs. 20,000/As Per SRO/40
gm
Rs. 180
60ml
Rs. 270
90ml
Rs. 360
120ml
Form 5-D
for Very good, Panel

recommends all
for the additional
sections as per
approved layout
for plan. (24-06-14)
1.Complete details regarding

international availability
especially in FDA, EMA,
Health Canada, TGA &
MHLW for same generic,
dosage form & strength
with reference (e.g print of
relevant
countrys
regulatory
agency
approval and URL of
website etc) are required.
The Firm has given the
reference
of
Italian
Medicine Agency.
2.Firm
has
already
submitted summary data
of accelerated stability
(One Lab scale batch of 1
liter size for 6months,
Two pilot scle batches
size
10
liters
for
3months) and real time
stability (One Lab scale
batch of 1 liter size for
12months, Two pilot scle
batches size 10 liters for
3months)
BNF: Dalacin
VAGIBACT
VAGINAL
CREAM
(NABIQASIM)
Grant of
additional section
Cream/Ointment
97
234.
235.
236.
(Vol-IV) dated
25-02-2015)
Specifications)
-do-
Fosmin Cream
Contains:Isotretinoin B.P.
0.05% w/w
(Vitamin A
analogue (retinoid);
Treatment of acne)
(Manufacturers
Spec.s)
Form 5
R&I 1381, 0403-2015
gm
Fusirum Cream
Contains:Fusidic Acid B.P.
2.0% w/w
(Antibacterial)
(B.P.
Specifications)
Form 5
R&I 1118 0307-2014,
gm & 15 gm
-do-
-do-
Fycam Gel
Contains:Piroxicam B.P.
0.5% w/w
(Cyclo-oxygenase
inhibitor; analgesic;
anti-inflammatory)
(B.P.
Specifications)
(General)
recommended.
(01-12-2014)
Not provided
ISOTROL
CREAM
(VALOR
PHARMA)
Grant of
additional section
Cream/Ointment
(General and
Steroidal)
recommended.
(01-12-2014)
Form 5
R&I 1113 0307-2014,
gm, 20 gm &
25 gm
1.The drug is sensitive to air,

heat and light and needs
specialized
equipments/
environment.
US-FDA, EMA, Health
Canada, TGA & MHLW
for same generic, dosage
form & strength not
provided/not confirmed.
BNF has approved the
formulation as a Gel
dosage form (Isotrex of
Steifel)
BNF: Fucidin
(LEO)
DERMY
CREAM
(WOODARDS)
Grant of
additional section
Cream/Ointment
(General and
Steroidal)
recommended.
(01-12-2014)
BNF: Feldene
0.5% Gel (Pfizer
Limited)
FELDENE GEL,
(PFIZER LAB)
Grant of
additional section
Cream/Ointment
(General and
Steroidal)
98
recommended.
(01-12-2014)
237.
238.
239.
-do-
-do-
-do-
Fynkoben Cream
Contains:Ibuprofen B.P.
10.0% w/w
(Cyclo-oxygenase
anti-inflammatory)
(B.P.
Specifications)
Form 5
R&I 1116 0307-2014,
gm
Locin Gel
Contains:Lignocaine HCl
Anhydrous B.P. 2%
w/w
(Local Anesthetics)
(B.P.
Specifications)
Form 5
R&I 203
14-01-2015,
gm
Orimazole - V
Vaginal Cream
Contains:Clotrimazole U.S.P.
2% w/w
(Antifungal)
(U.S.P.
specifications)
BNF : Ibugel
Forte (Dermal)
Karbufen
CREAM (Genix
Pharma)
Grant of
additional section
Cream/Ointment
(General and
Steroidal)
recommended.
(01-12-2014)
Australia:
Xylocaine 2%
Jelly
(AstraZeneca Pty
Ltd)
1.The formulation should meet

the
requirements
of
sterility as per B.P.
XYLOCAINE
(BARRET
HUODGSON)
Form 5
R&I 1114 0307-2014,
gm
Grant of
additional section
Cream/Ointment
(General and
Steroidal)
recommended.
(01-12-2014)
BNF: Canesten
Thrush (Bayer)
GYNOSPORIN
VAGINAL
CREAM
(NABIQASIM)
Grant of
additional section
Cream/Ointment
(General and
99
Steroidal)
recommended.
(01-12-2014)
240.
241.
242.
-do-
-do-
-do-
Ouench Cream
Contains:Silver Sulfadiazine
U.S.P. 1.0% w/w
(Antibacterial)
(U.S.P.
specifications)
Form 5
R&I 1123 0307-2014,
gm, 50 gm &
250 gm
Prefen Gel
Contains:Ketoprofen B.P.
2.5% w/w
(Cyclo-oxygenase
anti-inflammatory)
(B.P.
specifications)
Form 5
Voveron Gel
Contains:Diclofenac Sodium
(As Diethylamine)
B.P. 1% w/w
(Cyclo-oxygenase
anti-inflammatory)
(B.P.
specifications)
Form 5
R&I 1111 0307-2014,

gm
R&I 1125 0307-2014,

gm & 50 gm
BNF: Flamazine
(Solvay Pharma
B.V)
DERMAZIN
CREAM
(NOVARTIS)
Grant of
additional section
Cream/Ointment
(General and
Steroidal)
recommended.
(01-12-2014)
BNF: Oruvail
(Sanofi)
FASTUM GEL
(PHARMATEC)
Grant of
additional section
Cream/Ointment
(General and
Steroidal)
recommended.
(01-12-2014)
BNF: Voltarol
Emulgel
(Novartis)
VOLTRAL GEL
(NOVARTIS
PHARMA)
Grant of
additional section
Cream/Ointment
(General and
Steroidal)
recommended.
(01-12-2014)
100
243.
M/s MKB
Pharmaceuticals
(Pvt) Ltd.
66 Hayatabad
Industrial Estate,
Peshawar, KPK.
Prevasma Plus Dry

powder suspension.
Each reconstituted
5 mL suspension
contains:
Montelukast
Oral
Dry sodium equivalent
Powder
to
Montelukast
Suspension
(USP) --- 4 mg
Section
Fexofenadine HCl
(General):
(USP) ------- 30
mg.
No. F.6-3/2014Lic
(M-234 Leukotriene
/
dated
24-03- Histamine
2014)
antagonists.
Form 5
28-01-2015
(Diary No. 80)
Policy /60 mL
Montair - FX
(Cipla, India)
US-FDA, EMA, Health
Canada, TGA & MHLW
Not confirmed
form & strength not
cGMP
Compliance
at
Firm has claimed that the
excellent level.
(25-09-2014)
India.
Firm has claimed Monfex
of GT pharma that is not
confirmed.
(Manufacturers
specs)
244.
-do-
Cinclar 125 mg / 5
mL Dry powder
suspension.
Form 5
28-01-2015
(Diary No. 75)
Each reconstituted
5 mL contains:
Clarithromycin (as
taste
masked
granules 27.5 %)
125 mg
Rs. 20,000/Dy. No.
Klaricid (Abbott)
Claritek 125 mg /
5 mL
(Getz
Pharma)
Policy / 60 mL
cGMP
Compliance
at
excellent level.
(25-09-2014)
Form 5
Klaricid (Abbott)
As per DRAP
(Macrolide)
(USP Specs)
Source: M/s. Surge
Laboratories (Pvt.)
Ltd; Sheikhupura
245.
-do-
Cinclar 250 mg / 5
mL Dry powder
suspension.
28-01-2015
(Diary No. 83)
Each reconstituted
5 mL contains:
Clarithromycin (as
taste
masked
granules 27.5 %)
250 mg

Policy / 60 mL
Claritek 250 mg /
5 mL
( Getz
Pharma)
cGMP
Compliance
at
excellent level.
(25-09-2014)
101
(Macrolide)
(USP Specs)
Source: M/s. Surge
Laboratories (Pvt.)
Ltd; Sheikhupura
246.
-do-
Ciprobid 125 mg /
5 mL Dry powder
suspension.
Form 5
28-01-2015
(Diary No. 77)
Each reconstituted
5 mL contains:
Ciprofloxacin (as
Ciprofloxacin HCl
taste
masked
granules 22.2 %)
125 mg.
Ciproxin (Bayer)
Novidat 125 mg /
5 mL ( Sami
Pharma)
Policy / 60 mL
cGMP
Compliance
at
excellent level.
(25-09-2014)
Form 5
Ciproxin (Bayer)
Broad
Spectrum
Antibiotic
(Fluoroquinolone)
(Manufacturers
specs)
Source: M/s. Surge
Laboratories (Pvt.)
Ltd; Sheikhupura.
247.
-do-
Ciprobid 250 mg /
5 mL Dry powder
suspension.
28-01-2015
(Diary No. 86)
Each reconstituted
5 mL contains:
Ciprofloxacin (as
Ciprofloxacin HCl
taste
masked
granules 22.2 %)
250 mg

Policy / 60 mL
Novidat 250 mg /
5 mL ( Sami
Pharma)
cGMP
Compliance
at
excellent level.
(25-09-2014)
Broad
Spectrum
Antibiotic
(Fluoroquinolone)
(Manufacturers
specs)
Source: M/s. Surge
102
Laboratories (Pvt.)
Ltd; Sheikhupura.
248.
-do-
Mycocin 50 mg / 5
mL Dry powder
suspension.
Form 5
28-01-2015
(Diary No. 85)
Each reconstituted
5mL
suspension
contains:
Fluconazole
(U.S.P) 50 mg

Policy / 35 mL
Diflucan (Pfizer)
Derocon 50 mg /
5 mL ( Raazee
Therapeutics)
cGMP
Compliance
at
excellent level.
(25-09-2014)
Anti-Fungal
(U.S.P Specs)
249.
-do-
Zithrox 200 mg / 5
mL Dry powder
suspension.
Form 5
28-01-2015
(Diary No. 76)
Each reconstituted
5 mL suspension
contains:
Azithromycin (as
dihydrate) (U.S.P)
200 mg

Policy / 15 mL
& 30 mL
Zithromax
(Sandoz)
Azomax 200 mg /
5 mL (Novartis)
cGMP
Compliance
at
excellent level.
(25-09-2014)
Antibiotic
(Macrolide)
(U.S.P Specs)
250.
-do-
Lumesin
Dry
powder suspension.
Each reconstituted
5mL
suspension
contains:
Artemether
(Ph.
Int.) --15 mg
Lumefantrine (Ph.
Int.) -90 mg
Anti-malarial
Form 5
28-01-2015
(Diary No. 87)
Policy / 30 mL
& 60 mL
Co-Artesiane
(Dafra Pharma,
Belgium)
(Approved in M248)
Arceva
Dry
powder
suspension
(Sami Pharma)
cGMP
Compliance
at
103
( Ph. Int. Specs)
251.
-do-
Prevasma
Sachet.
excellent level.
(25-09-2014)
mg
Sachet Section
Each
Sachet
contains:
Montelukast
No. F.6-3/2014Sodium (U.S.P)
Lic (M-234
equivalent to
Montelukast --dated 24-034.0 mg
2014)
Leukotriene
inhibitor
(Anti asthmatic)
(General)
252.
-do-
(
Manufacturers
Specs)
Diracare Sachet.
Each Sachet
contains:
Sodium Chloride
(USP)
------------------ 2.6
gm
Sodium Citrate
(USP)
-------------------2.9 gm
Potassium
Chloride (USP)
----------------1.5
gm
Dextrose
Anhydrous (USP)
--------------13.5
gm
Form 5
28-01-2015
(Diary No. 78)
Singulair
(MSD)
Myteka
(HiltonPharma)
Sachets
cGMP
Compliance
at
excellent level.
(25-09-2014)
Form 5
BNF: WHO
Policy / 14
28-01-2015
(Diary No. 84)
Policy / 20
Sachets
recommended
Orsal
(Well
Sachet
&
Well
Pharma)
cGMP
Compliance
at
excellent level.
(25-09-2014)
Oral
electrolyte
replacer
( U.S.P Specs)
104
253.
-do-
Healium Insta 20
mg Sachet
Each
Sachet
contains:
Omeprazole (USP)
----- 20 mg
Sodium
Bicarbonate (USP)
---------- 1680 mg
Form 5
28-01-2015
(Diary No. 79)
Policy / 07 &
10 Sachets
Anti-ulcerants
(Proton
Pump
Inhibitors)
254.
-do-
(Manufacturers
Spec.s)
Healium Insta 40
mg Sachet
Each
Sachet
contains:
Omeprazole (USP)
----- 40 mg
Sodium
Bicarbonate (USP)
---------- 1680 mg
Form 5
28-01-2015
(Diary No. 81)
Policy / 07 &
10 Sachets
Anti-ulcerants
(Proton
Pump
Inhibitors)
Zegerid
(Santarus, USA)
Omega rapid 20
mg
sachet
(
Ferozsons
Laboratoies )
cGMP
Compliance
at
excellent level.
(25-09-2014)
Zegerid
(Santarus, USA)
Omega rapid 40
mg
sachet
(
Ferozsons
Laboratoies )
cGMP
Compliance
at
excellent level.
(25-09-2014)
(Manufacturers
Spec.s)
255.
-do-
Gastrofit Sachet
Each Sachet
contains:
Sodium
Bicarbonate (BP)
----------- 1.716
gm
Sodium Citrate
(BP) - 0.613gm
Citric Acid (BP)
--- 0.702 gm
Tartaric Acid (BP)
-- 0.858 gm
Form 5
28-01-2015
(Diary No. 82)
Policy / 20 &
100 Sachets
Not confirmed
US-FDA, EMA, Health
Citro
Soda
Canada, TGA & MHLW
Sachet (Abbott)
form & strength not
cGMP
Compliance
at 2.Firm has claimed that the
excellent level.
(25-09-2014)
Australia. The reference
formulation Ural (Aspen)
is not of the same strength.
Urinary and gastric

105
alkaliniser
(Manufacturers
Specs)
256.
M/s Sayyed
Pharmaceuticals
, Plot#67/2
Phase3,Industrial
Estate,Hattar
Pakistan.
Oral Dry Susp
Cephalosporin:
No. F 3-6/2006Lic dated 2502-2015)
257.
258.
-do-
-do-
Sayfim 100mg/5ml
Dry Susp
Each 5ml when
reconstituted
contains:Cefixime (as
Trihydrate U.S.P.)
100mg
(Cephalosporin
Antibiotic)
(U.S.P.
specifications)
Form 5
3/3/2015
R&I Diary No
150
Rs. 20,000/As Per
SRO/30ml
Sayfim 200mg/5ml
Dry Susp
Each 5ml when
reconstituted
contains:Cefixime (as
Trihydrate U.S.P.)
200mg
(Cephalosporin
Antibiotic)
(U.S.P.
specifications)
Form 5
3/3/2015
R&I Diary No
149
Rs. 20,000/As Per
SRO/ 30ml
Sayflar 125mg/5ml
Dry Susp
Contains.. Each
5ml when
reconstituted..
Cefaclor (as
Monohydrate
U.S.P.) 125mg
(Cephalosporin
Antibiotic)
(USP
specifications
Form 5
3/3/2015
R&I Diary No
130
Rs. 20,000/As Per
SRO/ 60ml
U.S.A: SUPRAX
AG-FIX 30ml
Dry
Susp(Saydon)
Grant of
additional section
Capsule/Dry
Susp
(Cephalosporin
Antibiotic)
recommended.
(06-12-2014)
U.S.A: SUPRAX
AG-FIX 30ml
Dry Susp(Sydon)
Grant of
additional section
Capsule/Dry
Susp
(Cephalosporin
Antibiotic)
recommended.
(06-12-2014)
FDA: Cefaclor
(YUNG SHIN
PHARM)
Ceclor Dry
Powder for
Suspension 125
mg (AGP
healthcare
Private Limited)
Grant of
additional section
Capsule/Dry
Susp
106
(Cephalosporin
Antibiotic)
recommended.
(06-12-2014)
259.
260.
-do-
-do-
Sayflar 250mg/5ml
Dry Susp
Contains.. Each
5ml when
reconstituted..
Cefaclor (as
Monohydrate
U.S.P.) 250mg
(Cephalosporin
Antibiotic)
(USP
Specifications
Form 5
3/3/2015
R&I Diary No
129
Rs. 20,000/As Per
SRO/60ml
Sayflar Drops
Contains.. Each ml
when
reconstituted..
Cefaclor (as
Monohydrate
U.S.P.)50mg
(Cephalosporin
Antibiotic)
(USP specifications
Form 5
3/3/2015
R&I Diary No
131
Rs. 20,000/As Per
SRO/15ml
FDA: Cefaclor
(YUNG SHIN
PHARM)
Ceclor Dry
Powder for
Suspension 250
mg (AGP
healthcare Private
Limited)
Grant of
additional section
Capsule/Dry
Susp
(Cephalosporin
Antibiotic)
recommended.
(06-12-2014)
FDA: Cefaclor
(YUNG SHIN
PHARM),
(250mg/5ml)
AG-CLOR
50mg/ml Drops
(SAYDON)
Grant of
additional section
Capsule/Dry
Susp
(Cephalosporin
Antibiotic)
recommended.
(06-12-2014)
107
261.
262.
-do-
-do-
Say-Drox
125mg/5ml
Dry Susp
Contains.. Each
5ml when
reconstituted..
Cefadroxil (as
Monohydrate
U.S.P.) 125mg
(Cephalosporin
Antibiotic)
(U.S.P
specifications)
Form 5
3/3/2015
R&I Diary No
134
Rs. 20,000/As Per
SRO/ 60ml
Say-Drox
Form 5
3/3/2015
R&I Diary No
138
Rs. 20,000/As Per
SRO/60ml
250mg/5ml
Dry Susp
263.
-do-
Each 5ml when

reconstituted..
Cefadroxil (as
Monohydrate
U.S.P.) 250mg
(Cephalosporin
Antibiotic)
(U.S.P.
specifications
Sayfruxime Dry
Susp
Each 5ml when
reconstituted..
Cefuroxime (as
Axetil U.S.P.)
125mg
(Cephalosporin
Antibiotic)
(USP specifications
Form 5
3/3/2015
R&I Diary No
147
Rs. 20,000/As Per
SRO/ 50ml
FDA:
Cefadroxil
(Ranbaxy)
AG-DROX
125mg/5ml
D.S(SAYDON
Grant of
additional section
Capsule/Dry
Susp
(Cephalosporin
Antibiotic)
recommended.
(06-12-2014)
FDA: Cefadroxil
(Ranbaxy)
Duricef
By GSK
Grant of
additional section
Capsule/Dry
Susp
(Cephalosporin
Antibiotic)
recommended.
(06-12-2014)
BNF: Zinnat
(GSK)
ZINACEF125mg
/5ml (GSK)
Grant of
additional section
Capsule/Dry
Susp
(Cephalosporin
Antibiotic)
recommended.
(06-12-2014)
108
264.
265.
-doCapsule
(Cephalosporin):
No. F 3-6/2006Lic dated 2502-2015)
-do-
Say-CEPH 250mg
Capsule
Each Capsule
contains..
Cephradine (as
Monohydrate
U.S.P.) 250mg
(Cephalosporin
Antibiotic)
(U.S.P.
specifications
Form 5
3/3/2015
R&I Diary No
148
Say-CEPH 500mg
Capsule
Contains..
Cephradine (as
Monohydrate
U.S,P) 500mg
(Cephalosporin
Antibiotic)
(U.S.P.
Form 5
3/3/2015
R&I Diary No
147
specifications
266.
-do-
Sayfim 400mg
Capsule
Each Capsule
contains..
Cefixime (as
Trihydrate U.S.P.)
400mg
(Cephalosporin
Antibiotic)
Form 5
3/3/2015
R&I Diary No
151
(U.S.P
specifications
267.
-do-
Sayflar 250mg
Capsule
Contains..
Cefaclor (as
Monohydrate
U.S.P.) 250mg
(Cephalosporin
Antibiotic)
Form 5
3/3/2015
R&I Diary No
137
BNF: Nicef
Velosef Bristol
Myres
Grant of
additional section
Capsule/Dry
Susp
(Cephalosporin
Antibiotic)
recommended.
(06-12-2014)
BNF: Nicef
Velosef Bristol
Myres
Grant of
additional section
Capsule/Dry
Susp
(Cephalosporin
Antibiotic)
recommended.
(06-12-2014)
U.S.A: SUPRAX
Ceficure 400mg
Capsule(Max
Pharma)
Grant of
additional section
Capsule/Dry
Susp
(Cephalosporin
Antibiotic)
recommended.
(06-12-2014)
BNF: Keftid
Ceclor (AGP)
Grant of
additional section
Capsule/Dry
Susp
109
(USP
specifications)
268.
-do-
Sayflar 500mg
Capsule
Contains..
Cefaclor (as
Monohydrate
U.S.P.) 500mg
(Cephalosporin
Antibiotic)
(USP
(Cephalosporin
Antibiotic)
recommended.
(06-12-2014)
Form 5
3/3/2015
R&I Diary No
132
specifications)
269.
270.
-do-
M/s Saydon
Pharmaceutical
Industries (Pvt)
Ltd. 77-A
Hayatabad
Industrial Estate
Peshawar.
Liquid Injection
(Psychotropic)
Section
Say-Drox 500mg
Capsule
Contains..
Cefadroxil (as
Monohydrate
U.S.P.) 500mg
(Cephalosporin
Antibiotic)
(U.S.P
specifications
Form 5
3/3/2015
R&I Diary No
140
Ogesic Inj
Each 1ml ampoule
Contains:Pentazocine (as
Lactate) (U.S.P)
30mg
(Narcotic
analgesic)
(U.S.P)
Form 5
17-01-2011
Rs. 8,000/07-01-2015
Rs. 12,000/(F.16-4/2013Reg-IV dated
27-04-15)
As Per SRO
BNF:
Distaclor
(Flynn)
Ceclor (AGP)
Grant of
additional section
Capsule/Dry
Susp
(Cephalosporin
Antibiotic)
recommended.
(06-12-2014)
BNF: Cefadroxil
(Non-proprietary)
Duricef 500 mg
capsules (GSK
Pakistan Private
Limited)
Grant of
additional section
Capsule/Dry
Susp
(Cephalosporin
Antibiotic)
recommended.
(06-12-2014)
FDA: Talwin
(Hospira
Healthcare Inc.)
Sosegon (Sanofi
Aventis Karachi)

the assay of API. Firm has
submitted an undertaking
that they will purchase
before
marketing
of
product.
Grant of
additional section
Liquid Injection
(Psychotropic)
110
No. F.2-5/94-Lic
(Vol. II) dated
24-01-2011)
271.
272.
273.
-do-
-do-
-do-
recommended.
(24-01-2011)
Routine GMP 1302-15
Brugesic Inj
Each 1ml ampoule
Contains:Buprenorphine (as
HCl) (USP)
0.3mg
(Opiate analgesic)
(B.P Spec.s)
Form 5
10-03-2011
Rs. 8,000/07-01-2015
Depam Inj
10mg/ml
Each 2ml ampoule
contains:Diazepam B.P
20mg
(Benzodiazepine)
(B.P Spec.s)
Form 5
21-01-2015
Depam Inj 5mg/ml

Each 2ml ampoule
contains:Diazepam(BP)
10mg
(Benzodiazepine)
(B.P)
Form 5
17-01-2011
Rs. 8,000/07-01-2015
FDA: Buprenex
(Reckitt
Benckiser)

the assay of API.
Temegesic
(Reckitt
Benckiser)
Grant of
additional section
Liquid Injection
(Psychotropic)
recommended.
(24-01-2011)
FDA: Diazepam
(Hospira)

the assay of API.
Valium (Martin
Dow Karachi)
Grant of
additional section
Liquid Injection
(Psychotropic)
recommended.
(24-01-2011)
Not
confirmed/Not
provided
Valium (Martin
Dow Karachi)
Grant of
additional section
Liquid Injection
(Psychotropic)
recommended.
(24-01-2011)

the assay of API.
US-FDA, EMA, Health
Canada, TGA & MHLW
form & strength not
3.Me-too
status
needs
confirmation.
111
274.
275.
276.
-do-
-do-
M/s
Roryan
Pharmaceutical
Industries PVT
Limited,
Industrial Estate
Hayatabad,
Peshawar.
Psychotropic
(Tablet) Section
No. F.3-3/2001Lic dated 26-012011)
Midalam Inj
5mg/5ml
Each 5ml ampoule
contains:Midazolam (as
HCl) (BP) 5mg
(Benzodiazepine)
(B.P)
Pheno Inj
Each ml ampoule
contains:Phenobarbitone
(BP) 200mg
(Barbiturates)
(B.P)
Lorazep
Tablet
Form 5
24-08-2010
Rs. 8,000/07-01-2015
Form 5
21-01-2015
Rs. 20,000/(Dy. No. 64
As Per SRO
1mg Form 5
23-04-2015
Rs. 20,000/Each
Tablet (Dy. No. 1094)
Contains:(F.16-4/2013Lorazepam (B.P) Reg-IV dated
1mg
10-04-15 &2304-15)
(Benzodiazepine
Tranquilizer)
As Per SRO /
10 x10s
(B.P. Specification)
FDA: Midazolam
( FRESENIUS
KABI USA )

the assay of API.
Dormicum
(Martin
Dow/Roche
Karachi)
Grant of
additional section
Liquid Injection
(Psychotropic)
recommended.
(24-01-2011)
TGA:
Phenobarbitone
(Aspen)
Phenobarbitone
(Amros)
Grant of
additional section
Liquid Injection
(Psychotropic)
recommended.
(24-01-2011)
FDA: ATIVAN
1mg (Lorazepam)

the assay of API.
2.Phenobarbital sodium is used
in injection with 9:1ratio
of propylene glycol and
WFI. Proposed master
formulation
is
not
according to B.P.

the assay of API. Firm has
submitted an undertaking
ATIVAN
1mg
that they will purchase
(Lorazepam) Reg
before
production
of
No. 000083
product.
PFIZER
PHARMA
Grant
of
additional section
psychotropic
(Tablet)
recommended.
(26-01-2011)
C GMP Latest
112
Inspection Report
Held on 11-122014
By FDI Peshawar
277.
-do-
Lorazep
Tablet
2mg Form 5
23-04-2015
Rs. 20,000/Each
Tablet (Dy. No. 1098)
Contains:(F.16-4/2013Lorazepam (B.P) Reg-IV dated
2mg
10-04-15 &2304-15)
(Benzodiazepine
As Per SRO /
Tranquilizer)
10 x 10s
278.
279.
-do-
-do-
DIZEP 5mg Tablet
FDA: ATIVAN
2mg (Lorazepam)

the assay of API.
ATIVAN
2mg
(Lorazepam) Reg
No. 001284
PFIZER
PHARMA PVT
LTD PAKISTAN
Grant
of
additional section
psychotropic
(Tablet)
recommended.
(26-01-2011)
GMP
Latest
Inspection Report
Held on 11-122014
By FDI Peshawar
BNF: 5mg
(Diazepam)
the assay of API.
Form 5
23-04-2015
Each
Tablet (1096)
VALIUM
5mg
Contains:Rs. 20,000/(Dizepam) Reg
Diazepam (B.P)
No. 003066
5mg
As Per SRO / 3
MARTIN DOW
x 10s
PHARMA
(Benzodiazepine
As Per SRO / KARACHI
Tranquilizer)
1000 x Jar
DIZEP
10mg Form 5
Tablet
23-042015(1097)
Each
Tablet Rs. 20,000/Contains:Dizepam (B.P) As Per SRO / 3
BNF: 10 mg
(Diazepam)

the assay of API.
VALIUM 10mg
(Dizepam) Reg
No. 003480
MARTIN DOW
113
10mg
(Benzodiazepine
Tranquilizer)
x 10s
PHARMA
As Per SRO / KARACHI
1000 x Jar
PAKISTAN
280.
-do-
281.
-do-
PHENOBAR 30mg Form 5

BNF:
(Phenobarbital
Tablet
23-04-2015
the assay of API.
Tablets)
(1093)
Each
Tablet Rs. 20,000/Phenotab 30mg
Contains:(Phenobarbitone)
Phenobarbitone
As Per SRO / 3
Reg No. 016020
(B.P)30mg
x 10s
WILSHIRE
As Per SRO /
PHARMA
(Barbiturate)
1000 x Jar
LAHORE
PAKISTAN
RONAX
1mg Form 5
FDA: XANAX
1mg
Tablet
09-04the assay of API.
(Alprazolam)
2015(183)
Each
Tablet Rs. 20,000/XANAX
1mg
Contains:(Alprazolam)
Alprazolam (B.P) As Per SRO / 3
Reg No. 013349
1mg
x 10s
PFIZER
PHARMA
(Benzodiazepine
KARACHI
Tranquilizer)
PAKISTAN
282.
-do-
RONAX
0.5mg Form 5
FDA: XANAX
0.5mg
Tablet
09-04the assay of API.
(Alprazolam)
2015(184)
Each
Tablet Rs. 12,000/XANAX 0.5mg
Contains:(Alprazolam)
Alprazolam (B.P)
Reg No. 012303
0.5mg
19-07-2010
PFIZER
Rs. 8,000/PHARMA
(Benzodiazepine
KARACHI
Tranquilizer)
As Per SRO / 3
PAKISTAN
x 10s
114
283.
-do-
DEPNIL
Tablet
3mg Form 5
09-042015(186)
Tablet Rs. 12,000/-
Lexotan (TGA)

the assay of API.
LAXOTANIL
Each
3mg
Contains:(Bromazepam)
Bromazepam (B.P) 19-07-2010
Reg No. 001043
3mg
Rs. 8,000/MARTIN DOW
PHARMA
(Benzodiazepine
As Per SRO / 3 KARACHI
Tranquilizer)
x 10s
PAKISTAN
Case No.06: Remaining Registration Applications of New / Additional sections.

The Registration Board has been granting 10 products per section to newly approved sections.
Following are the remaining products of the applicants as per above policy.
Evaluator II
S/N
Name
and Brand Name
Type of Form
address
of
date,
manufacturer / (Proprietary name Initial
+
Dosage
Form
+
diary
Applicant
Strength)
Fee including
Composition
differential fee
Pharmacological
Group
Finished
product
Specification
284.
M/s Highnoon
Laboratories
Ltd. 17.5
Kilometer,
Multan Road
Lahore.
(SemiSolid
Section (Cream,
ointment) No. F.
1-30/92-Lic
(Vol-VI) dated
Dermaco Cream
Each gm contains:Pimecrolimus
0.01gm
(Immunomodulatin
g agent)
(Manufacturers
Spec.s)
International
status in stringent
regulatory
agencies
Me-too status
GMP status as
depicted
in
Demanded
inspection
report
Price / Pack
(dated)
size
Form 5-D
Rs. 15000/(02-11-2011
(Dy. No. N/A)
+Rs. 35000/(21-11-14)
Rs. 3200/ Tube
of 30gm
Rs. 1600/Tube
of 15 gm
FDA: Elidel (
VALEANT
BERMUDA)
Form 5-D
09-03-2015
(Good level of
compliance with
GMP
guidelines)
1.Registration Board in its

248th
meeting
has
deferred
the
case
regarding
Area
requirement
for
Immunosuppressants
for further discussion on
scientific grounds.
2.The firm has seven
products
already
registered in the same
115
9th August, 2012
285.
286.
-do-
-do-
Rs. 1200/Tube
of 10 gm
Xe-pin Cream
Each gm contains:Doxepin
Hydrochloride (B.P)
0.05gm
(Antipruritis)
(Manufacturers
Spec.s)
Ranex Gel
Each gm contains:Becaplermin
0.0001gm
(Platelet Derived
Growth Factor)
(Manufacturers
Spec.s)
Form 5-D
Rs. 8000/- (2010-2011+
Rs.7,000/-(1708-12)
(Dy. No. N/A)
+Rs. 35000/(30-07-13)
Rs. 300/Tube
of 15 gm
Rs. 550/Tube
of 30 gm\
Rs. 850/Tube
of 45 gm
Form 5-D
Rs. 8000/- (2510-2011+
Rs.7,000/-(1708-12)
(Dy. No. N/A)
+Rs. 35000/(21-11-14)
Rs. 350/Tube
of 10 gm
Rs. 450/Tube
of 15 gm
Rs. 550/Tube
of 30 gm
section. One product

ebernet
cream
(Eberconazole) is under
process of registration.
3.Laboratory
scale
scientifically
rational
stability data is required.
4.Expert opinion.
FDA: Zonalon
1.Expert opinion.
Form 5-D
09-03-2015
(Good level of
compliance with
GMP
guidelines)
FDA:
REGRANEX (
OMJ
PHARMACEU
TICALS )
Form 5-D
09-03-2015
(Good level of
compliance with
GMP
guidelines)
1.The drug is produced by

recombinant
DNA
technology.
2.Specfications of active
starting material(s) i.e.,
API
(Active
Pharmaceutical
Ingredient)
with
reference
(preferrably
pharmacopoeial if any)
are required.
3.Laboratory
scale
scientifically
rational
4.Expert opinion.
116
287.
288.
289.
-do(Sachet General
Section)
No. F. 1-30/92Lic (Vol-VI)
dated 9th August,
2012
Axesom 20 Sachet
Each sachet
contain:Esomeprazole (as
magnesium
trihydrate gastro
resistant granules)
20mg
(Proton pump
inhibitor)
{Source of
granules: M/s
Vision
Pharmaceuticals
Plot # 224, Street #
01, I-10/3 ,
Industrial Area ,
Islamabad.}
-doAxesom 40 Sachet
Each sachet
contain:Esomeprazole (as
magnesium
trihydrate gastro
resistant granules)
40mg
(Proton pump
inhibitor)
{Source of
granules: M/s
Vision
Pharmaceuticals
Plot # 224, Street #
01, I-10/3 ,
Industrial Area ,
Islamabad.}
M/s EG
Abalin 150mg
Pharmaceuticals, Capsule
Plot # 13-A
Each Capsule
Industrial
contains:Triangle, Kahuta Pregabalin
Road Islamabad. 150mg
(GABA analogue)
(Manufacturers
Spec.s)
Form 5-D
Rs. 50,000/(20-06-13)
Rs. 375.00/14
Sachets
Form 5-D
Rs. 50,000/(20-06-13)
Rs. 425.00/14
Sachets
Form 5
07-08-2012
Rs.8000/Dy. No. 8262
20-06-2014
Rs.12000/Dy. No. 797
FDA: Nexium
(Astrazeneca)
Form 5-D
1.Laboratory
scale
scientifically
rational
2.Expert opinion.
09-03-2015
(Good level of
compliance with
GMP
guidelines)
FDA: Nexium
(Astrazeneca)
Form 5-D
1.Laboratory
scale
scientifically
rational
2.Expert opinion.
09-03-2015
(Good level of
compliance with
GMP
guidelines)
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50,
75,
100 and
117
As per
SRO/14s
150mg)
Hilton
cGMP certificate
for export may be
issued
(10.03.2015)
Evaluator III
S/N
Name
and Brand Name
Type of Form
address
of
name
+ Initial
date,
Dosage
Form
+
Strength)
diary
Applicant
Composition
Finished
Specification
290.
M/s
Wenovo
Pharmaceuticals,
Plot No. 31 & 32,
Punjab
Small
Industrial Estate,
Taxila.
OMENOV Sachet
International
Remarks
status
in
reference drug
agencies
/
Demanded
depicted
in
size
latest inspection
report
(with
date) by the
Evaluator
Form 5
Each sachet contains:Dy. No: 2300

Omeprazole20 mg
dated
02-04Sodium
bicarbonate 2015.
1680mg
Rs. 20,000/(Proton pump inhibitor)
As Per SRO /
7s, 14s, 20s,
28s, 30s.
Zegrid of
Santarus Inc.
Risek Insta by
M/s Getz
Pharmaceuticals
Firm was
inspected on 1203-2015 by the
area FID and
found GMP
compliant.
118
291.
-do-
ACENOV 200 mg Sachet
(Expectorant)
Not found in
reference
dated
02-04Mucolator Sachet
2015.
of Abbott
Rs. 20,000/-
Acetylcysteine..200 mg
Form 5
Laboratories
(Pakistan)
Limited.
Firm submitted
that formulation
is approved by
the ANSM
France
(ACETYLCYST
EINE 200mg
sachet of Biogran
France)
As Per SRO /
30s.
Evaluator V
Sr.
No.
Name
and
address
of
Manufacturer /
Applicant
Brand Name
(Proprietary name
+ Dosage form +
Strength)
Type of Form
Initial date, diary.
Composition
Fee
including
differential fee
Pharmacological
Group
Demanded Price /
Pack size
International
status
in
stringent
regulatory
agencies
Remarks /
Observations
Me-too status
Finished product
specification
292.
M/s
Ipram
International, Plot
#
26,
S-S-3,
National Industrial
Zone,
Rawat,
Islamabad.
Capsule
(Cephalosporin)
section approved
by
Central
Licensing Board in
its 239th meeting
held on 22-012015 (vide letter
No. F. 1-13/98-Lic
[Vol-I]
dated
25/02/2015)
Ipraceph 500mg
Capsule.
Form 5
Each Capsule
Contains:Cephradine U.S.P.
500mg
Rs.20000/Dy. No. 9787 R&I

Dated 19-11-2012
Anti-Biotic,
1stGeneration
Cephalosporin
Price: As fixed by
Govt.
2x6s
GMP status as
depicted
in
inspection
report (dated)
NICEF
500mg
Capsules
Cefradine
MHRA
VELOSEF
500mg Capsules
GSK
Copy of panel
inspection report
dated 01-01-2015
for
grant
of
renewal of DML
and grant of
additional section
i.e.,
Capsule
Section
(Cephalosporin).
Panel
recommended
grant of renewal
1) An undertaking (on
letter head) that in
case of resemblance /
similarity with already
registered brands the
applicant would be
liable to change the
brand name.
2) An undertaking /
commitment (on letter
head) regarding the
submission
of
following,
before
marketing the product,
as per decision of the
Registration
Board,
may be submitted for
consideration by the
Board:
i.
Stability studies
119
and
additional ii.Pharmaceutical
section.
development
studies
iii.Validation
of
analytical testing
methods
iv.Process validation
3) Undertaking that
label
claim
and
prescribing
information shall be
same as approved by
reference
drug
agencies e.g., FDA,
TGA, MHLW, EMA
and Health Canada.
4)
Evidence
of
approval of same
formulation
by
reference
drug
agencies e.g., FDA,
TGA, MHLW, EMA
and Health Canada
required.
5) Indications, dosage
information etc., to be
submitted as approved
by reference drug
agencies e.g., FDA,
TGA, MHLW, EMA
and Health Canada.
6) Source of active
and in-actives along
with their role and
justification
for
quantity
used.
Moreover,
API
specifications
are
incorrect.
7) Testing method and
acceptance criteria for
the finished product
are not according to
USP.
8) Details of reference
standard required.
9) Attested copy of
DML along
with
evidence of approval
of technical staff by
licensing required.
120
293.
M/s
Ipram
International, Plot
#
26,
S-S-3,
National Industrial
Zone,
Rawat,
Islamabad.
Mecef 500mg
Capsule.
Form 5
Each Capsule
Contains:Cefadroxil
BP
500mg
Rs.20,000/Dy. No. 9788 R&I

Dated 19-11-2012
Anti-Biotic, 1st
Generation
Cephalosporin
Price: As fixed by
Govt.
2x6s
CEFADROXIL
(as monohrdrate)
500mg
US FDA
DURICEF
500mg
GSK
applicant would be
brand name.
2) An undertaking /
head) regarding the
submission
of
following,
before
Registration
Board,
Board:
Copy of panel
inspection report
dated 01-01-2015
for
grant
of
renewal of DML
and grant of
additional section
i.e.,
Capsule
Section
(Cephalosporin).
Panel
recommended
grant of renewal
i.
Stability studies
and
additional ii.Pharmaceutical
section.
development
studies
iii.Validation
of
analytical testing
methods
3) Undertaking that
label
claim
and
prescribing
same as approved by
reference
drug
agencies e.g., FDA,
TGA, MHLW, EMA
and Health Canada.
4)
Evidence
of
approval of same
formulation
by
reference
drug
agencies e.g., FDA,
TGA, MHLW, EMA
and Health Canada
required.
information etc., to be
121
by reference drug
agencies e.g., FDA,
TGA, MHLW, EMA
and Health Canada.
6) Source of active
with their role and
justification
for
quantity
used.
Moreover,
API
specifications
are
incorrect.
7) Testing method and
acceptance criteria for
the finished product
are not according to
USP.
standard required.
9) Attested copy of
DML along
with
licensing required.
294.
M/s
Ipram
International, Plot
#
26,
S-S-3,
National Industrial
Zone,
Rawat,
Islamabad.
Cilicef 200mg
Capsule.
Form 5
Each Capsule
Contains:Cefixime as
trihydrate
200mg
Rs.20000/Dy. No. 9786 R&I

Dated 19-11-2012
Anti-Biotic,
Cephalosporin
Price: As fixed by
Govt.
Firm
has
mentioned
SUPRAX 200mg
of M/s Lupin
USA. However,
the
FDA
approved
strength
of
SUPRAX
is
400mg capsule.
CEFIM
200mg Capsules
M/s Hilton
applicant would be
brand name.
2) An undertaking /
head) regarding the
submission
of
following,
before
Registration
Board,
Board:
i.
Stability studies
ii.Pharmaceutical
development
studies
122
iii.Validation
of
analytical testing
methods
3) Undertaking that
label
claim
and
prescribing
same as approved by
reference
drug
agencies e.g., FDA,
TGA, MHLW, EMA
and Health Canada.
4)
Evidence
of
approval of same
strength by reference
drug agencies e.g.,
FDA, TGA, MHLW,
EMA and Health
Canada required.
information etc., for
200mg formulation to
be
submitted
as
approved by reference
drug agencies e.g.,
FDA, TGA, MHLW,
EMA and Health
Canada.
6) Source of active
with their role and
justification
for
quantity used.
7) Finished product
specifications
of
400mg capsules have
been
submitted.
Moreover, the method
of analysis (assay by
HPLC) is incomplete.
standard required.
9) Attested copy of
DML along
with
licensing required.
295.
M/s
Ipram Ipraclor 500mg
International, Plot Capsule.
Form 5
Not mentioned
123
#
26,
S-S-3,
National Industrial
Zone,
Rawat,
Islamabad.
Each Capsule
Contains:
Cefaclor
U.S.P.500mg
Anti-Biotic, 2nd
Generation
Cephalosporin
Rs.20000/21-01-2015
Dy. No. 405 R&I
Price: As fixed by
Govt.
2x6s
CEFACLOR
500mg Capsule
M/s Yung Sin
Pharm
US FDA
CECLOR
M/s AGP
applicant would be
brand name.
2) An undertaking /
head) regarding the
submission
of
following,
before
Registration
Board,
Board:
i.
Stability studies
ii.Pharmaceutical
development
studies
iii.Validation
of
analytical testing
methods
3) Undertaking that
label
claim
and
prescribing
same as approved by
reference
drug
agencies e.g., FDA,
TGA, MHLW, EMA
and Health Canada.
4)
Evidence
of
approval of same
strength by reference
drug agencies e.g.,
FDA, TGA, MHLW,
EMA and Health
Canada required.
information etc., for
200mg formulation to
be
submitted
as
approved by reference
drug agencies e.g.,
FDA, TGA, MHLW,
124
EMA and Health

Canada.
6)
Under
manufacturing method
Cefadroxil
is
mentioned.
7) Source of active
with their role and
justification
for
quantity used.
8) Finished product
specifications
of
Cephradine have been
submitted.
standard required.
10) Attested copy of
DML along
with
licensing required.
296.
M/s
Ipram
International, Plot
#
26,
S-S-3,
National Industrial
Zone,
Rawat,
Islamabad.
Cilicef 400mg
Capsule.
Form 5
Each Capsule
Contains:
Cefixime as
trihydrate.400mg
Rs.20000/Dy. No. 9785 R&I

Dated 19-11-2012
Antibiotic
(Cephalosporin)
Price: As fixed by
Govt.
SUPRAX 400mg
Capsule
US FDA
CEBOSCH
400mg capsule
M/s Bosch
applicant would be
brand name.
2) An undertaking /
head) regarding the
submission
of
following,
before
Registration
Board,
Board:
i.
Stability studies
ii.Pharmaceutical
development
studies
iii.Validation
of
analytical testing
125
methods
3) Undertaking that
label
claim
and
prescribing
same as approved by
reference
drug
agencies e.g., FDA,
TGA, MHLW, EMA
and Health Canada.
6) Source of active
with their role and
justification
for
quantity used.
7)
Reference
for
proposed method of
analysis
required.
Moreover, the method
of analysis (assay by
HPLC) is incomplete.
standard required.
9) Attested copy of
DML along
with
licensing required.
297.
M/s
Aventek
Pharmaceuticals
(Pvt) Ltd., 44-C,
Sunder Industrial
Estate, Lahore.
Tablet (General)
section approved
by
Central
Licensing Board in
its 239th meeting
held on 22-012015 (vide letter
No. F. 1-70/2005Lic
dated
25/02/2015)
POXETINE 60mg
Tablet
Each
tabletcontains:
Dapoxetine (as
Hcl) .60mg
Form 5
Not mentioned
Rs. 8,000/Dated 26-06-2012
PRILIGY
60mg tablet
MHRA
(for
premature
ejaculation)
Rs. 12,000/Dated 09-03-2015

Dy. No. 1494 R&I
Antidepressant
Manufacturers
specifications
Price: Rs. 830/10s
Me too status
requires
confirmation
Copy of panel
inspection report
conducted on 2108-2014. Panel
recommended
renewal
of
license.
1) Antidepressant has
been mentioned as
pharmacological
group,
whereas,
premature ejaculation
has been mentioned
under
proposed
indications.
Clarification required.
2) Undertaking that
label
claim
and
prescribing
same as approved by
reference
drug
agencies e.g., FDA,
TGA, MHLW, EMA
and Health Canada.
3)
Evidence
of
approval of same
formulation
by
126
298.
M/s
Aventek
Pharmaceuticals
(Pvt) Ltd., 44-C,
Sunder Industrial
Estate, Lahore.
AVEMOX400mg
Tablet
Each
tabletcontains:
Moxifloxacin (as
Hcl) .400mg
Form 5
Rs. 8,000/Dated 26-06-2012
Rs. 12,000/Dated 09-03-2015
Dy. No. 1503 R&I
Quinolones
Manufacturers
specifications
Price: Rs. 475/5s
AVELOX
400mg f/c tablet
US FDA
AVELOX
400mg f/c tablet
M/s Bayer
reference
drug
agencies e.g., FDA,
TGA, MHLW, EMA
and Health Canada.
4) Evidence of me too
status required.
5) Source of active
with their role and
justification
for
quantity used.
standard required.
7)
Evidence
of
approval of technical
staff by licensing
required.
8) Verification of Rs.
12,000/and
Rs.
8,000/- fee challan
required.
1) Undertaking that
label
claim
and
prescribing
same as approved by
reference
drug
agencies e.g., FDA,
TGA, MHLW, EMA
and Health Canada.
2) Quantity of API
(401mg) per tablet is
not in accordance with
label claim.
3) Source of active
with their role and
justification
for
quantity used.
4) Method of analysis
is incomplete / vague.
Moreover, acceptance
criteria for assay has
not been mentioned.
standard required.
6)
Evidence
of
staff by licensing
required.
127
299.
M/s
Aventek
Pharmaceuticals
(Pvt) Ltd., 44-C,
Sunder Industrial
Estate, Lahore.
AVEFLOX250mg
Tablet
Each
tabletcontains:
Levofloxacin (as
Hemihydrate)
... 250mg
Quinolones
Form 5
Rs. 8,000/Dated 26-06-2012
Rs. 12,000/Dated 09-03-2015
Dy. No. 1501 R&I
LEVAQUIN
250mg f/c tablet
US FDA
TAVANIC
250mg tablet
M/s Sanofi
Price: Rs. 250/10s
USP specifications
300.
M/s
Aventek
Pharmaceuticals
(Pvt) Ltd., 44-C,
Sunder Industrial
Estate, Lahore.
AVEFLOX 500mg
Tablet
Each
tabletcontains:
Levofloxacin (as
Hemihydrate)
... 500mg
Quinolones
USP specifications
Form 5
Rs. 8,000/Dated 26-06-2012
Rs. 12,000/Dated 09-03-2015
Dy. No. 1495 R&I
Price: Rs. 415/10s
LEVAQUIN
500mg f/c tablet
US FDA
TAVANIC
500mg tablet
M/s Sanofi
1) Undertaking that
label
claim
and
prescribing
same as approved by
reference
drug
agencies e.g., FDA,
TGA, MHLW, EMA
and Health Canada.
2)
Evidence
of
approval of same
formulation
by
reference
drug
agencies e.g., FDA,
TGA, MHLW, EMA
and Health Canada.
3) Quantity of API
label claim.
4) Source of active
with their role and
justification
for
quantity used.
5) Finished product
specifications
of
500mg
tablet
submitted.
standard required.
7)
Evidence
of
staff by licensing
required.
1) Undertaking that
label
claim
and
prescribing
same as approved by
reference
drug
agencies e.g., FDA,
TGA, MHLW, EMA
and Health Canada.
2)
Evidence
of
approval of same
formulation
by
reference
drug
agencies e.g., FDA,
TGA, MHLW, EMA
128
and Health Canada.

3) Quantity of API
label claim.
4) Source of active
with their role and
justification
for
quantity used.
5) Finished product
specifications
of
250mg
tablet
submitted.
standard required.
7)
Evidence
of
staff by licensing
required.
301.
M/s
Aventek
Pharmaceuticals
(Pvt) Ltd., 44-C,
Sunder Industrial
Estate, Lahore.
AVEROXIN
250mg Tablet
Each
tabletcontains:
Ciprofloxacin (as
Hcl) ... 250mg
Form 5
Rs. 8,000/Dated 26-06-2012
Rs. 12,000/Dated 09-03-2015
Dy. No. 1499 R&I
Quinolones
BP specifications
Price: Rs. 180/10s
CIPRO
250mg f/c tablet
US FDA
CIPROXIN
250mg tablet
M/s Bayer
1) Undertaking that
label
claim
and
prescribing
same as approved by
reference
drug
agencies e.g., FDA,
TGA, MHLW, EMA
and Health Canada.
2)
Evidence
of
approval of same
formulation
by
reference
drug
agencies e.g., FDA,
TGA, MHLW, EMA
and Health Canada.
3) Quantity of API
label claim.
4) Source of active
with their role and
justification
for
quantity used.
standard required.
6)
Evidence
of
staff by licensing
129
required.
302.
M/s
Aventek
Pharmaceuticals
(Pvt) Ltd., 44-C,
Sunder Industrial
Estate, Lahore.
AVEROXIN
500mg Tablet
Each
tabletcontains:
Ciprofloxacin (as
Hcl) ... 500mg
Form 5
Rs. 8,000/Dated 26-06-2012
Rs. 12,000/Dated 16-03-2015
Dy. No. 1708 R&I
CIPRO
500mg f/c tablet
US FDA
CIPROXIN
500mg tablet
M/s Bayer
Quinolones
BP specifications
303.
M/s
Aventek
Pharmaceuticals
(Pvt) Ltd., 44-C,
Sunder Industrial
Estate, Lahore.
GLIPTIN 50mg
Tablet
Each
tabletcontains:
Vildagliptin
50mg
Price: Rs. 180/10s
Form 5
Rs. 8,000/Dated 26-06-2012
Rs. 12,000/Dated 16-03-2015
Dy. No. 1706 R&I
Anti diabetic
Manufacturers
specifications
Price: Rs. 2112/28s
GALVUS
50mg tablet
TGA
GALVUS
50mg tablet
M/s Novartis
1) Undertaking that
label
claim
and
prescribing
same as approved by
reference
drug
agencies e.g., FDA,
TGA, MHLW, EMA
and Health Canada.
2)
Evidence
of
approval of same
formulation
by
reference
drug
agencies e.g., FDA,
TGA, MHLW, EMA
and Health Canada.
3) Quantity of API
label claim.
4) Source of active
with their role and
justification
for
quantity used.
standard required.
6)
Evidence
of
staff by licensing
required.
1) Undertaking that
label
claim
and
prescribing
same as approved by
reference
drug
agencies e.g., FDA,
TGA, MHLW, EMA
and Health Canada.
3) Under identification
test
for
finished
product,
Gliclazide
has been mentioned.
4) Source of active
with their role and
justification
for
quantity used.
130
304.
M/s
Aventek
Pharmaceuticals
(Pvt) Ltd., 44-C,
Sunder Industrial
Estate, Lahore.
AVETOSE-F
Tablets
Each
tabletcontains:
Iron Polymaltose
complex..100mg
Folic
acid.0.35mg
Haematinic
Form 5
Rs. 8,000/Dated 26-06-2012
FEROSOFT FA
100/0.35mg
M/s Hilton
Rs. 12,000/Dated 16-03-2015

Dy. No. 1705 R&I
Price: Rs. 200/2x10s
Manufacturers
specifications
305.
M/s
Aventek
AVEGREL Tablets
Form 5
DuoCover
standard required.
6)
Evidence
of
staff by licensing
required.
8,000/- fee challan
required.
1) Undertaking that
label
claim
and
prescribing
same as approved by
reference
drug
agencies e.g., FDA,
TGA, MHLW, EMA
and Health Canada.
Firms has submitted
details
of
study
conducted at the Post
Graduate Institute of
Medical
Education
and
Research,
Chandigarh,
India
under
proposed
dosage.
2) Identification test
not mentioned under
finished
product
specifications.
Moreover
assay
method for ferrous
sulphate instead of
Iron Polymaltose has
been submitted.
3) Source of active
with their role and
justification
for
quantity used.
standard required.
5)
Evidence
of
staff by licensing
required.
8,000/- fee challan
required.
1) Undertaking that
131
Pharmaceuticals
(Pvt) Ltd., 44-C,
Sunder Industrial
Estate, Lahore.
Each
tabletcontains:
Clopidogrel.
75mg
Aspirin75mg
Antiplaletst,
analgesic
antipyretic
Rs. 8,000/Dated 26-06-2012

Rs. 12,000/Dated 09-03-2015
Dy. No. 1504 R&I
Price: Rs.110/2x10s
Manufacturers
specifications
306.
M/s
Aventek
Pharmaceuticals
AVELUME
Form 5
75/75mg
EMA
label
claim
and
prescribing
same as approved by
reference
drug
agencies e.g., FDA,
TGA, MHLW, EMA
and Health Canada.
Moreover, indications
to
be
revised
accordingly.
2) Master formulation
and
manufacturing
method for plain tablet
have been submitted.
However,
internationally
the
product is available as
a
bilayer
tablet.
Rectification required.
Moreover, evidence of
availability
of
manufacturing facility
for
bilayer
tablet
required.
3) Label claim to be
revised in accordance
to
internationally
approved
formulations.
4)
Batch
size,
quantities to be used
per batch, source of
active and in-actives
along with their role
and justification for
quantity used required.
5) Finished product
specifications to be
revised
as
per
internationally
available formulation.
standard required.
7)
Evidence
of
staff by licensing
required.
1) Undertaking that
label
claim
and
132
(Pvt) Ltd., 44-C,

Sunder Industrial
Estate, Lahore.
Each tablet
contains:
Artemether...80mg
Lumefantrine
480mg
Synthetic
antimalarial
derived from
artemisinin/Synthet
ic recemic fluorine
mixture.
Rs. 8,000/Dated 26-06-2012
ARCEVA
M/s Sami
Rs. 12,000/Dated 16-03-2015

Dy. No. 1704 R&I
Price: 264/- per
pack.
8s
Manufacturers
specifications
307.
M/s
Aventek
Pharmaceuticals
(Pvt) Ltd., 44-C,
Sunder Industrial
Estate, Lahore.
AVEOME 20mg
Capsule
Each
capsulecontains:
Omeprazole.
20mg (BP)
Proton pump
inhibitor
B.P specifications
Source of pellets:
M/s Smilax
Laboratories
Limited.,
Plot No. 12/A,
Phase-III, I.D.A.,
Jeedimetla,
Hyderabad 500
Form 5
Rs. 8,000/Dated 26-06-2012
Rs. 12,000/Dated 09-03-2015
Dy. No. 1502 R&I
Price: Rs.200/- per
pack
RISEK
M/s Getz
prescribing
same as approved by
reference
drug
agencies e.g., FDA,
TGA, MHLW, EMA
and Health Canada.
Firms has submitted
details
of
study
conducted at the Post
Graduate Institute of
Medical
Education
and
Research,
Chandigarh,
India
under
proposed
dosage.
2) Source of active
with their role and
justification
for
quantity used.
standard required.
4)
Evidence
of
staff by licensing
required.
8,000/- fee challan
required.
1) Undertaking that
label
claim
and
prescribing
same as approved by
reference
drug
agencies e.g., FDA,
TGA, MHLW, EMA
and Health Canada.
3) Since the pellets of
Omeprazole
are
intended
to
be
imported,
therefore,
following are required:
a) Balance fee Rs.
80,000/b) Accelerated and
real time stability data
c) Valid legalized
GMP certificate of
source
133
055,
State
308.
M/s
Aventek
Pharmaceuticals
(Pvt) Ltd., 44-C,
Sunder Industrial
Estate, Lahore.
Telangana
2)
Evidence
of
staff by licensing
required.
AVEOME 40mg
Form 5
Each Capsule
contains:
Omeprazole
...40mg (BP)
Rs. 8,000/Dated 26-06-2012
Proton pump
inhibitor
B.P specifications
RISEK
M/s Getz
Rs. 12,000/Dated 16-03-2015

Dy. No. 1707 R&I
Price: not
mentioned (page
missing)
Source of pellets:
M/s
Smilax
Laboratories
Limited.,
Plot No. 12/A,
Phase-III, I.D.A.,
Jeedimetla,
Hyderabad 500
055,
Telangana
State
309.
M/s
Aventek
Pharmaceuticals
(Pvt) Ltd., 44-C,
Sunder Industrial
Estate, Lahore.
DIATEK Capsule
Form 5
Each Capsule
contains:
Diacerein.
50mg
Rs. 8,000/Dated 26-06-2012
Anti Osteoarthritis
Rs. 12,000/Dated 09-03-2015

Dy. No. 1505 R&I
Manufacturers
specifications
Price: Rs.810/Per pack
DIORA
50mg Capsules
M/s Getz
1) Undertaking that
label
claim
and
prescribing
same as approved by
reference
drug
agencies e.g., FDA,
TGA, MHLW, EMA
and Health Canada.
Omeprazole
are
intended
to
be
imported,
therefore,
a) Balance fee Rs.
c) Valid legalized
GMP certificate of
source
3)
Evidence
of
staff by licensing
required.
1) Undertaking that
label
claim
and
prescribing
same as approved by
reference
drug
agencies e.g., FDA,
TGA, MHLW, EMA
and Health Canada.
2)
Under
recommended clinical
use interactions with
other drugs has been
mentioned. Indications
and
dosage
information to be
by reference drug
agencies e.g., FDA,
134
310.
M/s
Aventek
Pharmaceuticals
(Pvt) Ltd., 44-C,
Sunder Industrial
Estate, Lahore.
TRANSOBIQ
Form 5
Each Capsule
contains:
Tranexamic acid
.500mg
Rs. 8,000/Dated 26-06-2012
Hemostatic
311.
M/s
Aventek
Pharmaceuticals
(Pvt) Ltd., 44-C,
Sunder Industrial
Estate, Lahore.
Rs. 12,000/Dated 16-03-2015

Dy. No. 1711 R&I
Manufacturers
specifications
Price: 325/- 2x10s
AOXTINE
Form 5
Each Capsule
contains:
FluxetineHcleq to
Fluoxetine 20mg
Rs. 8,000/Dated 26-06-2012
5-HT reuptake
inhibitor
B.P specifications
MAXNA
500mg Capsules
M/s AGP
Rs. 12,000/Dated 16-03-2015

Dy. No. 1710 R&I
Price: 75/- per
pack.
FLUOXETINE
HYDROCHLOR
IDE
20mg Capsules
US FDA
DEPEX
M/s Merck
TGA, MHLW, EMA

and Health Canada.
3)
Evidence
of
approval of same
formulation
by
reference
drug
agencies required.
4)
Evidence
of
staff by licensing
required.
1) Undertaking that
label
claim
and
prescribing
same as approved by
reference
drug
agencies e.g., FDA,
TGA, MHLW, EMA
and Health Canada.
2)
Evidence
of
approval of same
formulation
by
reference
drug
agencies required e.g.,
FDA, TGA, MHLW,
EMA and Health
Canada.
3)
Evidence
of
staff by licensing
required.
8,000/- fee challan
required.
1) Undertaking that
label
claim
and
prescribing
same as approved by
reference
drug
agencies e.g., FDA,
TGA, MHLW, EMA
and Health Canada.
2)
Evidence
of
approval of same
formulation
by
reference
drug
agencies required e.g.,
FDA, TGA, MHLW,
EMA and Health
135
312.
M/s
Aventek
Pharmaceuticals
(Pvt) Ltd., 44-C,
Sunder Industrial
Estate, Lahore.
AZTRO 250mg
Capsule.
Each Capsule
contains:
Azithromycin
Dihydrate eq. to
Azithromycin
..250mg
Macrolides
Form 5
Rs. 8,000/Dated 26-06-2012
Rs. 12,000/Dated 09-03-2015
Dy. No. 1498 R&I
ZITHROMAX
250mg capsule
TGA
AZOMAX
250mg Capsules
M/s Novartis
Price: 320/- per

pack.
10s
Manufacturers
specifications
313.
M/s
Aventek
Pharmaceuticals
(Pvt) Ltd., 44-C,
Sunder Industrial
Estate, Lahore.
ALENSO 30mg
Capsule.
Each Capsule
contains:
Lansoprazole
30mg
Proton pump
inhibitor
Manufacturers
specifications
Source of pellets:
M/s
Smilax
Laboratories
Limited.,
Plot No. 12/A,
Phase-III, I.D.A.,
Jeedimetla,
Hyderabad 500
055,
Telangana
State
Form 5
Rs. 8,000/Dated 26-06-2012
Rs. 12,000/Dated 09-03-2015
Dy. No. 1496 R&I
Price: 206/- per
pack.
14s
PREVACID
30mg capsule
US FDA
LANZOL
30mg Capsules
M/s Pharmatec
Canada.
3)
Evidence
of
staff by licensing
required.
8,000/- fee challan
required.
1) Undertaking that
label
claim
and
prescribing
same as approved by
reference
drug
agencies e.g., FDA,
TGA, MHLW, EMA
and Health Canada.
2)
Evidence
of
staff by licensing
required.
8,000/and
Rs.
12,000/- fee challan
required.
1) Undertaking that
label
claim
and
prescribing
same as approved by
reference
drug
agencies e.g., FDA,
TGA, MHLW, EMA
and Health Canada.
Lansoprazole
are
intended
to
be
imported,
therefore,
a) Balance fee Rs.
c) Valid legalized
GMP certificate of
source
3)
Evidence
of
staff by licensing
required.
136
314.
M/s
Aventek
Pharmaceuticals
(Pvt) Ltd., 44-C,
Sunder Industrial
Estate, Lahore.
AESMOL
Form 5
Each Capsule
contains:
Esomeprazole
Magnesium eq. to
Esomeprazole
.. 40mg
Rs. 8,000/Dated 26-06-2012
Proton pump
inhibitor
Price: 323/- per

pack.
Rs. 12,000/Dated 09-03-2015

Dy. No. 1497 R&I
NEXIUM
40mg capsules
US FDA
NEXUM
M/s Getz
Source of pellets:
M/s
Smilax
Laboratories
Limited.,
Plot No. 12/A,
Phase-III, I.D.A.,
Jeedimetla,
Hyderabad 500
055,
Telangana
State
315.
M/s
Aventek
Pharmaceuticals
(Pvt) Ltd., 44-C,
Sunder Industrial
Estate, Lahore.
AESMOL
Form 5
Each Capsule
contains:
Esomeprazole
Magnesium eq. to
Esomeprazole
.. 20mg
Rs. 8,000/Dated 26-06-2012
Proton pump
inhibitor
Price: 198/14s
Manufacturers
specifications
Source of pellets:
M/s
Smilax
Laboratories
Limited.,
Plot No. 12/A,
Rs. 12,000/Dated 09-03-2015

Dy. No. 1500 R&I
NEXIUM
20mg capsules
US FDA
NEXUM
M/s Getz
1) Undertaking that
label
claim
and
prescribing
same as approved by
reference
drug
agencies e.g., FDA,
TGA, MHLW, EMA
and Health Canada.
Esomeprazole
are
intended
to
be
imported,
therefore,
a) Balance fee Rs.
c) Valid legalized
GMP certificate of
source
3) Only assay method
given under finished
product specifications.
Details of all tests
along with acceptance
criteria required.
4)
Evidence
of
staff by licensing
required.
1) Undertaking that
label
claim
and
prescribing
same as approved by
reference
drug
agencies e.g., FDA,
TGA, MHLW, EMA
and Health Canada.
Omeprazole
are
intended
to
be
imported,
therefore,
a) Balance fee Rs.
c) Valid legalized
GMP certificate of
137
Phase-III, I.D.A.,
Jeedimetla,
Hyderabad 500
055,
Telangana
State
316.
M/s
Aventek
Pharmaceuticals
(Pvt) Ltd., 44-C,
Sunder Industrial
Estate, Lahore.
Avegab 100mg
Capsules
Each Capsule
contains:
Pregabalin .
100mg
Form 5
Rs. 8,000/Dated 26-06-2012
Rs. 12,000/Dated 16-03-2015
Dy. No. 1709 R&I
LYRICA
100mg Capsule
US FDA
GABICA
100mg Capsules
M/s Getz
Antiepileptic
Manufacturers
specifications
317.
M/s
Venus
Pharma, 23 Km,
Multan
Road,
Lahore.
DIANEX Capsule
Form 5
Each Capsule
contains:
Diacerein.
50mg
Rs. 20,000/Dated 05-03-2015

Dy. No. 1396 R&I
Anti Arthritic
318.
M/s
Venus
Pharma, 23 Km,
Multan
Road,
Lahore.
Price: 259/- per

pack 14s
Manufacturers
specifications
Pregab 50mg
Capsules
Each Capsule
contains:
Pregabalin
50mg
DIORA
50mg Capsules
M/s Getz
source
3) Only assay method
given under finished
product specifications.
Details of all tests
along with acceptance
criteria required.
4)
Evidence
of
staff by licensing
required.
1) Undertaking that
label
claim
and
prescribing
same as approved by
reference
drug
agencies e.g., FDA,
TGA, MHLW, EMA
and Health Canada.
2)
Evidence
of
staff by licensing
required.
8,000/- fee challan
required.
Evidence of approval
of same formulation
by reference drug
agencies required.
Price: Rs.850/Per 30s
Form 5
Rs. 20,000/Dated 05-03-2015
Dy. No. 1389 R&I
Price: 700/2x7s
LYRICA
50mg Capsule
US FDA
GABICA
50mg Capsules
M/s Getz
Antiepileptic
Manufacturers
specifications
138
319.
M/s
Venus
Pharma, 23 Km,
Multan
Road,
Lahore.
Pregab 75mg
Capsules
Each Capsule
contains:
Pregabalin
75mg
Form 5
Rs. 20,000/Dated 05-03-2015
Dy. No. 1392 R&I
Price: 1,000/2x7s
LYRICA
75mg Capsule
US FDA
GABICA
75mg Capsules
M/s Getz
Antiepileptic
320.
M/s
Venus
Pharma, 23 Km,
Multan
Road,
Lahore.
Manufacturers
specifications
Hefzol - 40
Form 5
Each Capsule
contains:
Esomeprazole
Magnesium
trihydrate eq. to
Esomeprazole
. 40mg
Rs. 20,000/Dated 05-03-2015

Dy. No. 1391 R&I
Proton pump
inhibitor
Price: 300/2x7s
Rs. 80,000/Dated 30-04-2015

Dy. No. Nil
NEXIUM
40mg capsules
US FDA
Legalized
GMP
certificate and real
time stability data
under Zone IV-A
conditions required.
NEXUM
M/s Getz
Manufacturers
specifications
321.
M/s
Venus
Pharma, 23 Km,
Multan
Road,
Lahore.
Source: M/s Ocean

Pharmaoat
Pvt.
Ltd., Plot No. 44,
Co-operative
Industrial Estate,
Gandhi
Nagar,
Balanagar,
Hyderabad,
500037, India
Hefzol - 20
Form 5
Each Capsule
contains:
Esomeprazole
Magnesium
trihydrate eq. to
Esomeprazole
. 20mg
Rs. 20,000/Dated 05-03-2015

Dy. No. 1390 R&I
Proton pump
inhibitor
Price: 250/2x7s
Rs. 80,000/Dated 30-04-2015

Dy. No. Nil
NEXIUM
20mg capsules
US FDA
Legalized
GMP
certificate and real
time stability data
under Zone IV-A
conditions required.
NEXUM
M/s Getz
Manufacturers
139
specifications
322.
M/s
Venus
Pharma, 23 Km,
Multan
Road,
Lahore.
Source: M/s Ocean

Pharmaoat
Pvt.
Ltd., Plot No. 44,
Co-operative
Industrial Estate,
Gandhi
Nagar,
Balanagar,
Hyderabad,
500037, India
Veprazole - 20
Form 5
Each Capsule
contains:
Omeprazole
. 20mg
Proton pump
inhibitor
Rs. 20,000/Dated 05-03-2015

Dy. No. 1393 R&I
PRILOSEC
US FDA
RISEK
M/s Getz
Price: 250/2x7s
Manufacturers
specifications
323.
M/s
Venus
Pharma, 23 Km,
Multan
Road,
Lahore.
Source: M/s Vision

Pharmaceuticals
Colax
Each Capsule
contains:
Thiocolchicoside
. 4mg
Skeletal Muscle
Relaxant
Form 5
Rs. 20,000/Dated 05-03-2015
Dy. No. 1395 R&I
Price: 650/20s
Manufacturers
specifications
324.
M/s
Venus
Pharma, 23 Km,
Multan
Road,
Lahore.
Hefrid OD - 150
Form 5
Each Capsule
contains:
Itopride
Hydrochloride
.. 150mg
Rs. 20,000/Dated 05-03-2015

Dy. No. 1398 R&I
Authorized
by
national
procedures
in
several
EU
Member States
(Czech Republic,
France, Greece,
Hungary, Italy,
Malta, Portugal
and Spain)
Thiocol
M/s Ray Pharma
Not found
Nogerd SR
M/s Helix
of same formulation
by reference drug
agencies required.
Price: 350/10s
Gastroprokinetic
Manufacturers
specifications
140
325.
M/s
Venus
Pharma, 23 Km,
Multan
Road,
Lahore.
Hefrid - 50
Form 5
Not found
Each Capsule
contains:
Itopride
Hydrochloride
.. 50mg
Rs. 20,000/Dated 05-03-2015

Dy. No. 1397 R&I
Not found
of same formulation
by reference drug
agencies required.
Price: 250/10s
Gastroprokinetic
326.
M/s
Venus
Pharma, 23 Km,
Multan
Road,
Lahore.
Manufacturers
specifications
Tramacet
Each Capsule
contains:
Tramadol
Hydrochloride
.. 37.5mg
Paracetamol
.. 325mg
Form 5
Not found
Rs. 20,000/Dated 05-03-2015

Dy. No. 1394 R&I
Not found
of same formulation
(capsule dosage form)
by reference drug
agencies required.
Price: 250/10s
Analgesic
Manufacturers
specifications
Case No.07: Deferred cases- replies submitted by firms
Evaluator III
Case: No. a
Following products of M/s Nortech Pharmaceuticals, Islamabad are discussed in the 243 rd meeting of
Registration Board and deferred for confirmation of approval of manufacturing facility of ampoule/ vials
(SVP) General, from licensing section. The firm has now submitted approval letter issued from licensing
division vide letter No: F.6-6/2014-Lic (M-237) dated 14-10-14 and requested for registration. The firm
141
further undertakes that they will install the TOC and Liquid Particle counter within the time frame granted
by the Registration Board in its 248th meeting.
S/N
Name
and Brand Name
Type of Form
address
of
name
+ Initial
date,
Applicant
Composition
Finished
Specification
327.
Demanded
depicted
in
size
latest inspection
report
(with
date) by the
Evaluator
M/s
Nortech Aqua-Nor Injection
Pharmaceuticals
(Pvt)
Limited, Each 5ml ampoule
contains:Islamabad.
Water for
Ampoule/
Vial Injection..5ml
SVP
(General)
(Solvent)
vide letter No. F.66/2014-Lic
(M- (USP)
237) dated 14-1014
328.
-do-
International
Remarks
status
in
reference drug
agencies
/
authorities
Fee including
Form 5
Dy No 8966
dated 21-012014
Water for
Injection (BNF)
Aqua-p of Ipram
Pharmaceuticals
Islamabad
Rs.20,000
As per SRO/
5mlx5s
5mlx10s
Amp.
Ketonor Injection 30mg
Form 5
Toradol of Roche
Each 1ml ampoule

contains:Ketorolac
Tromethamine.30mg
Dy No 8991
dated 21-012014
Tromit of
Standpharm
Rs.20,000
(NSAID)
USP
As per SRO/
1mlx5s
1mlx10s
Amp.
142
329.
-do-
Tropinor Injection 5mg
Form 5
Each 5ml ampoule

contains:Tropisetron as
HCl.5mg
Dy No 8967
dated 21-012014
Rs.20,000
(5HT3-antagonist)
330.
-do-
Manufacturer
As per SRO/
5mlx1s Amp.
Ayron Injection 100mg
Form 5
Each 5ml ampoule

contains:Iron (as Iron Sucrose)
100mg
Dy No 8990
dated 21-012014
Navoban
injection of
Novartis
Pharmaceuticals
Australia
Navoban
injection of
Novartis
Pharmaceuticals
Karachi Pakistan
Venofer (iron
sucrose injection,
USP) of
LUITPOLD
(American
Regent Inc)
Rs.20,000
(Anti-Anaemics)
331.
-do-
USP
As per SRO/
5mlx5s Amp.
Zonor Injection 50mg
Form 5
Each 2ml ampoule

contains:Ranitidine (as HCl)
..50mg
Dy No 8989
dated 21-012014
Rs.20,000
Besleri-S of Sami
Pharmaceuticals
Karachi
RANITIDINE
injection of
[Bedford
Laboratories]
Zantac of GSK
Karachi
(Antipeptic Ulcerants)
USP
332.
-do-
As per SRO/
2mlx5s
2mlx10s
Amp.
Vitanor-D Injection
Form 5
Not provided
Each 1ml ampoule

contains:Colecalciferol5mg
Dy No 8988
dated 21-012014
Calciferol of
Global
Pharmaceuticals
Islamabad
(Vitamin-D Analogue)
Rs.20,000
BP
As per SRO/
1mlx1s
1mlx5s Amp.
143
333.
-do-
Vominor Injection 10mg
Form 5
Each 2ml ampoule

contains:Metoclopramide (as HCl)
10mg
Dy No 8986
dated 21-012014
Reglan of Ani
Pharms
Clopan of Siza
Pharmaceuticals
Lahore
Rs.20,000
(Antidopaminergic)
334.
-do-
USP
Piroxinor Injection 20mg
Each 1ml ampoule
contains:Piroxicam20mg
As per SRO/
2mlx10s Amp.
Form 5
Dy No 8985
dated 21-012014
(anti-Rheumatics)
Rs.20,000/-
Feldene Injection
of Pfizer UK
Mobicam of
Global
Pharmaceuticals
Islamabad
Manufacturer
335.
-do-
Normic Injection 250mg
As per SRO/
1mlx5s Amp.
Form 5
Each 5ml ampule contains:Tranexamic

Acid..250mg
Dy No 8987
dated 21-012014
(Anti-hemorrhagic/Antihemophiliacs)
Rs.20,000/-
BP
336.
-do-
Meconor Injection 500mcg

Each 1ml ampoule
contains:Mecobalamin.500m
cg
(Coenzyme-type vitamin
B12)
Manufacturer
As per SRO/
5mlx5s
5mlx10s
Amp.
Form 5
Dy No 8987
dated 21-012014
Rs.20,000/-
Not found in
reference
agencies
The firm
submitted
reference of
Azeptil of
Brino of Sami Medochemie Ltd
Pharmaceuticals
Cyprus.
Karachi
Methycobal
Injection 500ug
of Eiasi Co. Ltd
Tokyo Japan
Neuromin of EG
Pharma
Islamabad.
As per SRO/
1mlx10s Amp.
Case: No. b
Following product of M/s MTI Lahore was deferred in the 246 th meeting of Registration Board and
deferred for below mentioned shortcomings. The firm has now rectified the shortcomings and requested
for registration.
144
S/N
Name and
address of
manufactu
rer
/
Applicant
Brand Name
(Proprietary
name + Dosage
Form
+
Strength)
Composition
Pharmacologic
al Group
Finished
product
Specification
Type
of
Form
Initial
date, diary
Fee
including
differentia
l fee
Demanded
Price
/
Pack size
337.
1
M/s MTI
Medical
(Pvt)
Limited,
586-587
Sunder
Industrial
Estate,
Raiwind
Road
Lahore.
APHOLAC
Suspension
Form-5
Internation Decision
al status in
reference
drug
agencies /
authorities
Me-too
status
GMP status
as depicted
in
latest
inspection
report
(with date)
by
the
Evaluator
Remarks
Duphalac of 1.Confirmatio 1. The area FID has

Solvay
n of dosage
submitted
vide
Dy
No: (USFDA)
form
and
letter
No.
Each
5ml 1052 dated
verification of
5215/2015-DRAP
contains:
26-09-2014 Duphalac of HPLC
dated
09-04-15
Abbot
Lactulose..3.3
equipped with
that the firm has
Pharma,
5gm
20,000/RI detector
installed the HPLC
Karachi
2.Fee
for
with RI detector
Import,
Laxative
As
per
and
found
3.Legalized
SRO/ Pack
operational.
GMP
2.
Firm
has submitted
BP
of 120ml
certificate of
80,000/&240ml
source,
differential fee.
Source:
M/s bottle
4.Stability
3.
The
firm
has
Fresenius Kabi
studies
submitted
that
they
Austria
will import the
lactulose from M/s
Fresenius
Kabi
Austria and in this
respect they have
submitted the copy
of GMP certificate
and stability data.
Submitted for consideration of Registration Board please.
Case No: c
145
Following product of M/s Ali Gohar & Co (Pvt) Limited, Karachi was deferred in the 247 th meeting of
Registration Board as due to submission of incomplete stability data. The firm has now submitted the
complete data and requested for registration.
338. Applicant
M/s Ali Gohar
& Co (Pvt)
Limited, State
Life Building
No. 1B
I.I Chundrigar
Road P.O. Box
5167 Karachi.
Manufacturer
Alcon
Laboratories,
Inc
6201
South
Freeway, Fort
Worth, Texas
76134, USA
PATADAY 0.2%
Form-5A
Each ml of
sterile
ophthalmic
solution
contains:
Olopatadine
HCL
2.22mg
equivalent
to
Olopatadine
..2mg
Dy. No. 29
dated
02-032010
Anti-allergic
Manufacturer
15,000/- dated
02-03-2010
35,000/- dated
26-03-13
Rs. 904/Pack of 4ml
Bottle
containing
2.5ml
of
solution
1. Deferred for
rectification of
shortcomings/
observations in
preceding
column.
2. Final notice for
rectification of
shortcomings/
observations.
Acclarted stability
data is provided
for
one
commercial lot of
pataday at 40
2C / 155%
relitvie humidity
through 6 months
which is not in
accordance with
the conditions of
(Firm was asked zone IV-A as per
to submit the ICH
/
WHO
stability
data guidelines.
In
conducted under addition long term
the Zone IV-A stability data is
conditions as per provided for one
ICH / WHO
commercial lot of
Guidelines. Only pataday at 30
long term study 2C / 755%
data is provided relitvie humidity
which
is how ever the
incomplete,
chromato grams
without
submitted for the
chromatograms
assay of active and
and protocols etc. degradation
Accelerated
products are of
stability data is different batches
also required)
as mentioned in
the stability data
sheet.

Case No: d
Following product of M/s PharmEvo Limited, Karachi as deferred in the 245 th meeting of Registration
Board due to following deficiencies. The firm has now rectified them and requested for registration.
146
S/N
Name
and
address
of
manufac
turer /
Applican
t
Brand Name
(Proprietary
name + Dosage
Form
+
Strength)
Composition
Pharmacologic
al Group
Finished
product
Specification
Type
of
Form
Initial
date, diary
Fee
including
differentia
l fee
Demanded
Price
/
Pack size
al status in
reference
drug
agencies /
authorities
Me-too
status
GMP status
as depicted
in
latest
inspection
report
(with date)
by
the
Evaluator
339. M/s
PharmEv
o (Pvt.)
Limited,
Plot No
A-29,
North
West
Industrial
Zone,
Port
Qasim,
Karachi.
Desven XR 100
mg
Tablet
Each
extended release
tablet contains
Desvenlafax ine
as
Succinate
.100 mg
Form 5 2308-2010
Dy.
No.
161
Rs.
8000
+
12000
10s= Rs
1980 14s=
Rs 2772
Me
too
Lafaxine by
Genix
International
Desvenlafax
ine
XR
tablet 100
mg (FDA)
Antidepressant
Finished
Product
Specifications
ns
are
Manufacture r
Deferred for
rectification
of following
observations .
1.
Undertaking
for
comparative
dissolution
profile
is
required.
International
availability
has
been
given
for
Desvenlafax
ine while firm
applied
for
Desvenlafax
ine
as
Succinate.
Remarks
Firm
has
submitted
the
undertaking
for
submission
of
comparative
dissolution profile
before marketing
of drug product.
Moreover
the
applied
formulation
is
FDA
approved
(Pristiq tablets of
Wyeth )
Submitted for consideration of registration board.

Case No: e
147
Following product of M/s Medisure Laboratories, (pvt) Limited Karachi as deferred in the 248 th meeting
of Registration Board due to following deficiencies. The firm has now rectified them and requested for
registration.
S/N
Name
and
address
of
manufac
turer /
Applican
t
Brand Name
(Proprietary
name + Dosage
Form
+
Strength)
Composition
Pharmacologic
al Group
Finished
product
Specification
340. M/s
Medisure
Laborator
ies, (Pvt)
Limited
Karachi.
Exzium Infusion
Type
of
Form
Initial
date, diary
Fee
including
differentia
l fee
Demanded
Price
/
Pack size
Form-5
Rs.8000/Each
vial Dy.
No.
contains:
R&I
Nil
Esomeprazole
Rs.12000/sodium 42.5mg Dy.
No.
equivalent
to R&I Nil 1s
Esomeprazole
Vail As per
.. 40mg
SRO
Sulphinyl
Benzimidazole
al status in
reference
drug
agencies /
authorities
Me-too
status
GMP status
as depicted
in
latest
inspection
report
(with date)
by
the
Evaluator
Remarks
NEXUM
40mg
Infusion
M/s Getz
The
firm
has
rectified
the
deficiencies
mentioned in the
preceding column.
Copy
of
inspection
report dated
22-23,
October,
2013
and
17-03-2014
(focused on
purchase,
storage and
utilization of
raw
materials)
submitted.
Deferred.
Final notice
of 30 days
for
rectification
of
below
mentioned
shortcomings
/
observations:
1) Finished
product
specifications
of
sterile
isoosmotic
solution
of
Esomeprazol
e and Sodium
Citrate
in
Water
for
Injection has
been
provided.
Rectification
148
required.
341. -do-
Pantop Infusion
Form
5
Rs.8000/Each
vial Dy.
No.
contains:
R&I
Nil
Pantoprazole as Rs.12000/Sodium
Dy.
No.
sesquihydrate
R&I Nil As
USP.
per
40mg
importing
countries.
H/K
Atpase
proton
pump
inhibitor.
342. -do-
Xopra Infusion
Form 5
Each
vial
contains:
Omeprazole as
Sodium BP
40mg (Suitably
buffered)
Rs.20000/Dated 0802-2013
Dy.
No.
R&I Nil 1s
Vail As per
SRO
H/K
Atpase
proton
pump
inhibitor
ZENTRO
Deferred.
40mg
Inj Final notice
M/s Bosch
of 30 days
for
Copy
of rectification
inspection
of
below
report dated mentioned
22-23,
shortcomings
October,
/observations
2013
and : 1) Finished
17-03-2014 product
(focused on specifications
purchase,
of
sterile
storage and isoosmotic
utilization of solution
of
raw
Pantoprazole
materials)
and Sodium
submitted.
Citrate
in
Water
for
Injection has
been
provided.
Rectification
required.
RISEK
Deferred.
40mg
Final notice
Infusion M/s of 30 days
Getz Copy for
of
rectification
inspection
of
below
report dated mentioned
22-23,
shortcomings
October,
/
2013
and observations:
17-03-2014 1) Finished
(focused on product
purchase,
specifications
storage and of
sterile
utilization of isoosmotic
raw
solution
of
materials)
Pantoprazole
submitted.
and Sodium
The
firm
has
rectified
the
deficiencies
mentioned in the
preceding column
The
firm
has
rectified
the
deficiencies
mentioned in the
preceding column
149
Citrate
in
Water
for
Injection has
been
provided.
Rectification
required.
343. -do-
Namadol
Injection
Form
5
Rs.8,000/Dated 09Each
ml 07-2012
contains:
Dy.
No.
Tramadol HCI R&I
Nil
. 50mg
Rs.12,000/Dated 12Analgesics and 03-2014
AntiDy.
No.
inflammatory
R&I Nil As
Agents
per
SRO
pack
of
2ml x 5
Ampoule
Tramadol
Hydrochlori
de 50mg/ml
MHRA
TRAMAL
50mg/ml
Searle
Copy
of
inspection
report dated
22-23,
October,
2013
and
17-03-2014
(focused on
purchase,
storage and
utilization of
raw
materials)
submitted.
Deferred.
Final notice
of 30 days
for
rectification
of
below
mentioned
shortcomings
/
observations:
1)
Justification
for the use of
Dextrose
Anhydrous
required.
2) Only assay
method and
identification
test
have
been
submitted for
the finished
product. Firm
to
provide
detailed
finished
product
The
firm
has
rectified
the
deficiencies
mentioned in the
preceding column
150
specifications
including test
for bacterial
endotoxin,
sterility etc.,
along
with
acceptance
criteria
for
each test. 3)
Clarification
regarding
dosage form
required, as
under
composition
2ml ampoule
has
been
proposed
(50mg / ml)
while under
labeling and
prescribing
information
1ml ampoule
has
been
mentioned.
Note:
Six
months time
for purchase,
installation
and
operational
qualification
of TOC and
liquid
particle
counter.
Meanwhile,
test
for
oxidizable
substances
may
be
performed
for organic
151
content.
Case No f:
Evaluator II
S/N
Name
and Brand Name
Type of Form
Decision
address
of
Previous
(Proprietary
name
Initial
date,
manufacturer
Meeting
+
Dosage
Form
+
diary
/ Applicant
Strength)
Fee including
Composition
differential fee
Pharmacological
Group
Finished product
Specification
344. M/s NovaMed

Pharmaceutica
ls (Pvt.) Ltd
28-km
Ferozepur
Road, Lahore
O-Quine Infusion
Each 100ml
infusion contains:Ofloxacin (USP)
200mg
(Flouroquinolones
Antibiotics)
(Manufacturers
Spec.s)
of Remarks on the formulation (i

including
International stat
stringent drug regulatory agen
authorities
GMP status as depicted in

inspection report (with date) b
Evaluator
Demanded
Price / Pack
size
Form 5
22-10-2014
Rs.20,000/(Dy. No. 1270)
Rs.
768.77/100ml
Infusion
Me-too status
1. Deferred for
rectifcation
of
shortcomings/
observations as in
preceding
column.
2. Final notice
for removal of
shortcomings.
BNF: Tarivid (Sanofi-Aventis)

Tarivid (Sanofi-Aventis)
The
Firm
shortcomings.
has
Case No. g. Registration of Drugs of Public Health Urgency on Priority Basis.

Committee for disposal of registration applications of public health urgency has decided to
process the registration application of 7.1% Chlorhexidine Digluconate Gel (4% active Chlorhexidine)
on priority basis. Following applications have been forwarded by registration sections to Pharmaceutical
Evaluation Cell for evaluation on priority basis.
Sr No.
Name
and
address
of
Manufacturer
/ Applicant
Brand Name
Type of
(Proprietary
Form
name
+
Dosage form +
Initial date,
Strength)
diary.
International
status in stringent
regulatory
agencies
Me-too status
Composition
Pharmacologic
al Group
Fee
including
differential
fee
GMP status as
depicted
in
inspection report
152
rectified
(dated)
Finished
product
specification
Demanded
Price / Pack
size
345.
M/s Dyson
Research
Laboratories
(pvt) limited,
28-Km,
Ferozepur
Road,
Lahore.
Hexidin Gel
Form 5-D
Not available in 1.The

firm
has
submitted
reference SRAs,
Chlorhexidine Acetate as a
Contains:16-12-2014
However
reference standard.
Chlorhexidine Rs. 50,000/- available
in 2.Laboratory scale scientifically
Gluconate B.P (Dy. No . WHO Model List
rational stability data is required.
7.1% eq. to 673)
of
Essential
3.Inspection report of manufacturers
Chlorhexidine
Medicines for
(dated 21-05-2014), mentions
.4%
As per SRO
Children
and
(Antiseptic)
Nepal, Nigeria.
that the firm was in the process
Contract
(B.P Spec.s)
of external revalidation of HVAC
Manufacturin
Form 5-D
system as per SOPs. They have
g by:
plan to shift this section within
M/s Dyson: GMP
six months.
M/s. Friends
compliance report
Pharma
Good
(Pvt.)
(26.09.2014)
Limited, 31Km,
M/s.
Friends
Ferozepur
Pharma:
Road,
Operations at the
Lahore.
factory premises
were compliant to
GMP
and
guidelines (21-052014), mentioning
Cream/ Ointment
section
but
observation that
the Firm was in
the process of
external
revalidation
of
HVAC system as
per SOPs. They
has plan to shift
this section within
six months.
346.
M/s
McOlson
Chlordine Gel
Form 5-D
Not available in 1.Initially form 5 was submitted.

reference SRAs,
153
Research
Laboratories
(pvt) limited,
Plot No 02,
M2Pharmazone,
26th
Km,
Lahore
Shariqpur
Road,
Sheikhupura.
Contract
Manufacturin
g by:
M/s. Biogen
Pharma,
8
Km,
ChakBeli
Road, Rawat,
Rawalpindi.
Case No. h.
Contains:Chlorhexidine
(as
Chlorhexidine
Digluconate
Solution Ph.
Eu 7.1% w/v)
.4% w/v
(Antiseptic)
(B.P Spec.s)
15-04-2015
Rs. 50,000/(Dy. No .
2569)
As per SRO
However
Later firm changed it to form 5available
in
D. However, Complete Form 5WHO Model List
D is required. Only covering
of
Essential
letter of Form 5-D has been
Medicines for
given.
Children
and
2.Copies
of Last GMP inspection
Nepal, Nigeria.
reports of both applicant and
Form 5-D
manufacturer
are
required.
cGMP
certificate
of
Not provided
manufacturer dated 06-05-13
valid upto 05-05-14 by area FID
has been provided.
3.Complete Specifications (Physical
& Chemical Characteristics) of
the container closure system
(Primary Packaging, Secodary
Packaging
&
Associated
components e.g., caliberated
spoon etc.) fulfilling the
compendial requirement are
required.
4.Undertaking of submitting before
marketing of the product,
Description of Suitability of
container
closure
system
comprising of parameters(i)
Protection
of
Drug(ii)
Compatibility of Drug(iii) Safety
of Drug &(iv) Performance of
Drug (Stability studies will
establish the the final suitability
of container closure system) is
required.
5.Laboratory scale scientifically
rational stability data is required.
Registration of Aprovasc Range (Irbesartan + Amlodipine) .
Drug Registration Board deferred following products of M/s Sanofi Aventis, karachi and advised
the firm to provide status about availability of products in SRAs and provide safety and efficacy data of
the drugs along with complete clinical trial data of these formulations.
154
S. No
Name of drug(s) & Composition
347. Aprovasc 300/10mg Tablet

Each tablet contains:
Irbesartan.300 mg
Amlodipine besylate.14 mg eq. to amlodipine10 mg
(Alntihypertensive, angiotensin II receptor antagonist)
Irbesartan.150 mg
Irbesartan.150 mg
Irbesartan.300 mg
It is submitted that the drug in above mentioned strength and combination is not approved
any of the reference regulatory authorities.
The firm has submitted that the fixed dose combination of Irbesartan + Amlodipine (in
the strength of Irbesartan 100mg /Amlodipine 5mg and Irbesartan 100mg /Amlodipine 10 mg)
is registered with PMD Japan by the name of AIMIX by Daipinppon Suitomo Pharma.
They have submitted that as the dosing in Japan is considerably lower than the USA or
Europe therefore the fixed dose combinations are of lower strength.
They have informed that that three Bioequivalence studies have been conducted for
Aprovasc and the results of these had been submitted to DRAP for review and these studies show
that the combination of Irbesartan + Amlodipine versus free individual molecule is safe and well
tolerated. Apart from these 2 randomized, open-label, multicenter, phase III trials were
conducted and published in peer reviewed index Journal, Clinical theraperutics (2012) and no
untoward side effects were observed with this combination other than those already reported for
the individual drugs.
The firm has requested for registration of the drug.
Submitted for consideration of Registration Board please.
Case No.08: Cases deferred for TOC Analyzer and Liquid Particle Counter
155
Following applications were deferred for TOC analyzer and liquid particle counter in previous
meetings. Registration board in its 248 th meeting has granted six months time for meeting above
requirement.
Applications deferred in 244th Meeting of Registration Board:
S.No
Name of
firm(s)
Name of drug(s) &

Composition
351. M/s Wenovo

Pharmaceuticals,
Plot No 31, 32,
Punjab Industrial
Estate, Taxila,
Rawalpindi.
Wink Injection
Each ml contains Iron
Isomaltoside equivalent to
elemental iron.100mg/ml
Iron deficiency anemia
Manufacturer
352.
Novoket Injection
Eachml contains Ketorolac
Tromethamole equivalent
to Ketorolac..
30mg/ml
NSAID
USP
353.
Novobal Injection
Each ml contains
Mecobalamin.500mcg
/ ml
Vitamin B-12
Manufacturer
354.
Novofer Injection
Each ml contains Iron
Sucrose equivalent to
Elemental Iron.20mg
Antianemic
Manufacturer
Formulations
already registered/
Int. availibility
Applied product is
not found in
stringent regulatory
agenceis.
Wisofer of
Wellmark
Pharmaceuticals
Hattar
Evidence of
availability of TOC
analyzer has not
been provided
Toradol of Roche
Torapan of
Caraway
Pharmaceuticals
Islamabad.
Evidence of
availability of TOC
analyzer has not
been provided
Applied product is
not found in
stringent regulatory
agencies.
Neuromet of Merck
Karachi
Evidence of
availability of TOC
analyzer has not
been provided
Venofer of
Fresenius Medical
care
Bisleri of Sami
Pharma Karchi
Evidence of
availability of TOC
analyzer has not
Decision
Deferred
for
final
reminder for provision
of
evidence
of
availability of TOC
analyzer.
Deferred
for
final
of
evidence
of
availability of TOC
analyzer.
Deferred for final

of evidence of
availability of TOC
analyzer.
Deferred for final

of evidence of
availability of TOC
analyzer.
156
355.
Wenowater Injection 5ml

Each ampoule contains
Water for Injection.5ml
USP
356.
Danvo Injection 8mg/4ml

Each 4ml contains
Ondansetron as
Hydrochloride..8mg
5HT3 receptor antagonist
USP
been provided
Wellwater of
Welwrd
Pharmaceuticals
Hattar
Evidence of
availability of TOC
analyzer has not
been provided
Zofran of GSK
(BNF-61)
Zofran GSK,
Karachi
Evidence of
availability of TOC
analyzer has not
been provided
Deferred for final

of evidence of
availability of TOC
analyzer.
Deferred for final

of evidence of
availability of TOC
analyzer.
Applications deferred in 245th Meeting of Registration Board

S/N.
Name
and Brand Name
address
of
manufacturer / (Proprietary name
+ Dosage Form +
Applicant
Strength)
Composition
Pharmacological
Group
Type
Form
of Remarks on the formulation Decision

(if
any)
including
International
status
in
Initial
stringent drug regulatory
date, diary agencies / authorities
Fee
including
differentia
l fee
Finished product Demanded

Specification
Price
/
Pack size
357. M/s Wenovo

Pharmaceutica
ls, Plot No 31,
32,
Punjab
Industrial
Estate, Taxila,
Rawalpindi.
Ketonov Injection
30mg/ml
Each
ampoule
contains:Ketorolac
Tromathamine
30mg/ml
NSAID
USP
Form 5
Dy
No.
626 dated
04/03/201
4
20,000/As
per
SRO
/Pack
of1ml x
Me-too status
GMP status as depicted in
latest inspection report (with
date) by the Evaluator
International
status
is Deferred for T
provided of 1ml vial of APP analyser
&l
Pharmaceuticals approved by particle counter.
USFDA
Ketorolac
of
Wnsfield
Pharmaceuticals Hattar.
Evidence of availability of
TOC is requires as USP
157
5s
specifications are claimed by

the firm

S.No
Name of
firm(s)
358. M/s
Elite
Pharma (Pvt)
Limited, 9.5
Km
Sheikhupura
Road Lahore
Name of drug(s) &

Composition
Flucolite Infusion 50ml
Formulations already registered
Decision
Diflucan of Pfizer.
Each ml contains:Fluconazole2mg
Diflucan of Pfizer Labs Karachi
Deferred for confirmation

of installation and
performance qualification
of TOC analyser & Liquid
Particle Counter by Area
FID.
Evidence of availability of TOC is

required as BP specifications are
claimed.
Antifungal
Manufacturer
359. -do-
Percemol
1gm/100ml
Infusion
Each 100ml conatins:Paracetamol1gm

Analgesic
360. M/s Schazoo
Pharmaceutic
als
Laboraories
Pvt. Ltd.
Kaolawala
Stop, 20, KM
Jaranwala
Road, District
Shehikhupura.
361. M/s Macter
International
Manufacturer
1.Ceretek
2.Injection
3.Each 1ml contains:
Haloperidol as lactate
5mg
4.Anti Psychotic
Mclevo Infusion 250mg
Panel inspection of the firm was

conducted on 28-01-13 and the
panel recommended the liquid
injectable infusion (100ml)
Perfalgan of BMS, UK
Provas of SAMI Pharmaceuticals
Karachi
Evidence of availability of TOC is
required as BP specifications are
claimed.

of installation and
performance qualification
FID.
FDA: Generic (Sagent Pharms)

Me too status confirmed

of installation and
operational qualification
Particle Counter by area
FID.
International:

of installation and
Levaquine
158
(Pvt.)
Limited. F216, S.I.T.E.,
Karachi.
Each 50 ml contains
250mg/50 ml (FDA)
Levofloxacin 250 mg
Local: Xeflox Inf

by M/s Helix
Broad Spectrum
Antibacterial Agent
250mg/50ml
operational qualifications
FID.
Finished Product
Specifications are
Manufacturer
362. M/s Macter
International
(Pvt.)
Limited.
F-216,
S.I.T.E.,
Karachi.
Micam Injection 8 mg
Each vial contains
Lornoxicam.8 mg
Me too Xefast tablet 8 mg by

PharmEvo
International Xefo powder for
injection 8 mg (EMA)
Analgesic & Anti

inflammatory

of installation and
operational qualification
FID.
Finished Product
Specifications are
363. M/s Wenovo

Pharmaceutic
als, Taxila
TRAMANOV Injection
Each
2ml
contains:
Tramadol
100mg
Tramdol Injection
Pharma UK
of
Beacon
ampoule
Lamadol of Brooks Karachi
HCL

of installation and
of TOC analyser & liquid
FID
Synthetic opiate analogue

364. -do-
Manufacturer
WENOFEN Injection
Each 2ml of amber glass
ampoule contains:
Diclofenac
Sodium..75mg
Lidocaine HCl..20mg
Analgesic,
anesthetic
365. M/s
Noble
Pharma,
Mirpur Azad
Kashmir
Availability in
confirmation
Dinopen of
Islamabad.
SRAs
Global
needs
Pharma,

of installation and
of TOC analyser & liquid
FID.
Local
Manufacturer
Nobivec Injection 2%
Each ml contains:
Ivermectin..20mg
Elvomec D/S of Elko Karachi

of installation and
of liquid Particle Counter
159
by Area FID.
Liquid
Injection
Section
(Veterinary)
Approved
vide letter No.
F.5-2/207 Lic
dated: 18-0213
366. -do-
Antiparasitic
BP
Nobivec Injection 1%
Actimec Injection of Selmore

Pharmaceuticals Lahore.
Each ml contains:
Ivermectin..10mg

of installation and
of liquid Particle Counter
by Area FID.
Antiparasitic
BP
367. M/s Decent
Pharma, Plot
No.30, Street
No.SS-3,
National
Industrial
Zone Rawat.
Gentasol Injection
Liquid Injection
Each ml Contains:
Gentamycin (as
Sulphate)
B.P100mg
Form 5
Rs.20,000/03-10-2014
Dy. No. 18
Decontrolled
/100ml
(Anti biotic)
Liquid
Injection
General
(Vet.)
granted vide
letter No. F.
6-2/2013-Lic
(M-233)
dated
3rd
February,
2013.
368. M/s Decent
Pharma, Plot
No.30, Street
No.SS-3,
National
Industrial
GENTOCIN INJ
100mg
Canada
GENTAJECT
10%
Gentamicin
As
Sulphate
100ml
International
Champharma,
Lahore.
Inspection report
dated 11-06-2014.
Company found
complying GMP.
Diatril Injection
Liquid Injection
Each ml Contains:
Enrofloxacin.100
mg
Form 5
Rs.20000/03-10-2014
Dy. No. 19
BAYTRIL 100
USA
ENROSAL
100ml
Zakfas, Multan
TOC analyzer and

particle counter
not available as
per
equipment
list.
However,
firm
has
submitted test for
oxidisable
substances as an
alternative
and
informed
that
TOC will be
purchased at a
later stage and
DRAP will be
informed.
1.
Deferred
for
availability
of
TOC
analyzer
and liquid
particle
counter
TOC analyzer and

particle counter
not available as
per
equipment
list.
However,
firm
has
1.
Deferred
for
availability
of
TOC
analyzer
160
Zone Rawat.
(Quinolone
Antibactrial)
369. M/s Decent

Pharma, Plot
No.30, Street
No.SS-3,
National
Industrial
Zone Rawat.
Spel Injection
Liquid Injection
Each ml Contains:
Spectinomycin (as
sulphate)
..100mg
Lincomycin (as
HCL)
.
50mg
Decontrolled
/100ml
Form 5
Rs.20000/03-10-2014
Dy. No. 20
Decontrolled
/100ml
(Antibiotic)
370. M/s Decent

Pharma, Plot
No.30, Street
No.SS-3,
National
Industrial
Zone Rawat.
Trodec L.A Injection

Liquid Injection
Each ml Contains:
Nitroxinil.340mg
(Antiparasitic)
Form 5
Rs.20000/03-10-2014
Dy. No. 21
Decontrolled
/100ml
Inspection report
dated 11-06-2014.
Company found
complying GMP.
L.S Injection
100/50mg (eq. to
base)
Holland
LINCOJECT S
INJ
100mg / 50mg
(eq. to base)
Intl.
Chempharma, Lhr
Inspection report
dated 11-06-2014.
Company found
complying GMP.
TRODAX 34%
Merial, UK
FASCIONIX 34%
Inj
340mg/ml
Better Traders
Inspection report
dated 11-06-2014.
Company found
complying GMP.
371. M/s Decent

Pharma, Plot
No.30, Street
No.SS-3,
National
Industrial
Zone Rawat.
Combi-4 Injection
Liquid Injection
Each ml Contains:
Tylosin tartrate
B.P.......................150
mg
Gentamycin sulphate
B.P..6
Form 5
Rs.20,000/03-10-2014
Dy. No. 17
Decontrolled
/100ml
TYLOCOMBISONE
15/6/0.0265/0.075
g / 100ml
Agrovet
Peru,
Albani,
Ecuador etc.
TYLO-
submitted test for

oxidisable
substances as an
alternative
and
informed
that
TOC will be
purchased at a
later stage and
DRAP will be
informed.
TOC analyzer and
particle counter
not available as
per
equipment
list.
However,
firm
has
submitted test for
oxidisable
substances as an
alternative
and
informed
that
TOC will be
purchased at a
later stage and
DRAP will be
informed.
TOC analyzer and
particle counter
not available as
per
equipment
list.
However,
firm
has
submitted test for
oxidisable
substances as an
alternative
and
informed
that
TOC will be
purchased at a
later stage and
DRAP will be
informed.
TOC analyzer and
particle counter
not available as
per
equipment
list.
However,
firm
has
submitted test for
oxidisable
substances as an
and liquid
particle
counter
1.
Deferred
for
availability
of
TOC
analyzer
and liquid
particle
counter
1.
Deferred
for
availability
of
TOC
analyzer
and liquid
particle
counter
1.
Deferred
for
availability
of
TOC
analyzer
and liquid
particle
counter
161
0mg
Chlorpheniramine
7.5mg
Dexamethasone
2.65mg
COMBISONE
15/6/0.0265/0.75g
/ 100ml
Mustafa Brothers
Inspection report
dated 11-06-2014.
Company found
complying GMP.
(Antibiotic/Anti
inflammatory)
372. M/s Decent

Pharma, Plot
No.30, Street
No.SS-3,
National
Industrial
Zone Rawat.
Titan Injection
Liquid Injection
Each ml Contains:
Tylosin (as tartrate)
B.P..........100mg
Gentamycin (as
sulphate)
B.P..50mg
Form 5
Rs.20000/03-10-2014
Dy. No. 16
Decontrolled
/100ml
Inspection report
dated 11-06-2014.
Company found
complying GMP.
(Antibiotec)
373. M/s Decent

Pharma, Plot
No.30, Street
No.SS-3,
National
Industrial
Zone Rawat.
Bomec LA Injection
Liquid Injection
Each ml Contains:
Ivermectin10mg
Vitamin
A.25000IU
Vitamin
D3.3750IU
Vitamin E25mg
PRIMACROGENT
INJ
100/50mg (eq. to
base)
Prix
Pharmaceutical
Form 5
Rs.20000/03-10-2014
Dy. No. 15
BOVIMEC LA
Agrovet, Peru
BOVIMEC INJ
Leads Pharma
Decontrolled
/50ml
Inspection report
dated 11-06-2014.
Company found
complying GMP.
Form 5
CLOSIVET
5 / 125mg
Ireland
alternative
and
informed
that
TOC will be
purchased at a
later stage and
DRAP will be
informed.
TOC analyzer and

particle counter
not available as
per
equipment
list.
However,
firm
has
submitted test for
oxidisable
substances as an
alternative
and
informed
that
TOC will be
purchased at a
later stage and
DRAP will be
informed.
1.
Deferred
for
availability
of
TOC
analyzer
and liquid
particle
counter
1.
Deferred
for
availability
of liquid
particle
counter
(Antiparasitic)
374. M/s Decent
Pharma, Plot
No.30, Street
No.SS-3,
National
Industrial
Zone Rawat.
Ectin-C Injection
Liquid Injection
Each ml Contains:
Ivermectin10mg
Closental..125m
g
Rs.20000/03-10-2014
Dy. No. 14
Decontrolled
/100ml
CLOXANTEL
PLUS INJ
Leads Pharma
1.
Deferred
for
availability
of liquid
particle
counter
162
(Antiparasitic)
375. M/s Decent

Pharma, Plot
No.30, Street
No.SS-3,
National
Industrial
Zone Rawat.
Tide Injection
Liquid Injection
Each ml Contains:
Tylosin
tartrate..50mg
Colistin Sulphate
10mg
Streptomycin..100m
g
Inspection report
dated 11-06-2014.
Company found
complying GMP.
Form 5
Rs.20000/03-10-2014
Dy. No. 13
Decontrolled
/100ml
COLISTREP-T
INJ
Attabak
Inspection report
dated 11-06-2014.
Company found
complying GMP.
(Antibiotic)
376. M/s Decent

Pharma, Plot
No.30, Street
No.SS-3,
National
Industrial
Zone Rawat.
OxytopInjection
Liquid Injection
Each ml Contains:
Oxytetracycline
Hydrochloride
B.P...50mg
Form 5
Rs.20000/03-10-2014
Dy. No. 12
Decontrolled
/50ml
ONYX 50 INJ
Breeze Pharma
Inspection report
dated 11-06-2014.
Company found
complying GMP.
(Antibiotic)
377. M/s
MACTER,
Krachi
MCLINE Injection
Form-5
Each 5ml ampoule

contains:
Sodium
Chloride45mg
Dy. No. 10
dated : 0211-10
Solvent
Manufacturer
8000/dated : 0211-10
12000/dated:31.7.2
013
As per PRC/
Soride of Bosch
Pharmaceuticals
Karachi
TOC analyzer and

particle counter
not available as
per
equipment
list.
However,
firm
has
submitted test for
oxidisable
substances as an
alternative
and
informed
that
TOC will be
purchased at a
later stage and
DRAP will be
informed.
TOC analyzer and
particle counter
not available as
per
equipment
list.
However,
firm
has
submitted test for
oxidisable
substances as an
alternative
and
informed
that
TOC will be
purchased at a
later stage and
DRAP will be
informed.
The FID reported
the availability of
TOC
analyzer
however
the
availability
of
liquid
particle
counter requires
confirmation.
1.
Deferred
for
availability
of
TOC
analyzer
and liquid
particle
counter
1.
Deferred
for
availability
of
TOC
analyzer
and liquid
particle
counter
1.
Deferred
for Liquid
Particle
Counter.
163
378. -do-
MACDRONIC
Infusion
Each 100ml solution
contains:
Zoledronic acid as
monohydrate..5mg
Osteoclastic Inhibitor
Manufacturer
379. -do-
MACDRONIC
Injection
Each 5ml contains:
Zoledronic acid as
monohydrate..4mg
Osteoclastic Inhibitor
Manufacturer
380. M/s Saydon,

Peshawar
Saydazole Infusion
500mg/ 100ml
Each 100 ml vial
contains:
Metronidazole..50
0mg
Amoebicide
USP
5ml ampoule
Form-5
Dy.No:
85
dated: 11-1110
Aclasta
Novartis UK
of
Reclast
of
Novartis Karachi
8000/- dated:
08-11-10
12,000/dated 31-0713
24,000/Pack
100ml
Form-5
The FID reported

the availability of
TOC
analyzer
however
the
availability
of
liquid
particle
counter requires
confirmation.
1.
Deferred
for Liquid
Particle
Counter.
The FID reported

the availability of
TOC
analyzer
however
the
availability
of
liquid
particle
counter requires
confirmation.
1.
Deferred
for Liquid
Particle
Counter.
Evidence
of
availability
of
TOC analyzer and
liquid
particle
counter is not
provided by the
firm.
1.
Deferred
for TOC
analyzer
and liquid
particle
counter.
2.
Final
notice for
rectificatio
n
of
shortcomin
gs/
observatio
ns.
of
Dy.No:
84
dated: 11-1110
8000/- dated:
08-11-10
12,000/dated 31-0713
16150/- Pack
of 5ml
Form-5
29-09-2010
Dy. No. 72
Zoledronic acid 4
mg/5
ml
concentrate
for
solution
for
infusion
of
Intrapharm Labs
UK.
Reclast
of
Novartis Karachi
Metronidazole
Infusion of Claris
Life
sciences
USFDA (plastic
PVC container)
20,000/As per SRO

Pack of 1s,
glass vial of
100ml USP
Type-I
Flagyl of Sanofi
Karachi
164
381. M/s Leads,

Islamabad
METHAMINE
Injection
Form-5
Megapyrone of
Star Labs Lahore
1.
Deferred
for TOC
and liquid
particle
counter.
Dy. No. 120

Each ml contains:
Mythampyrone..2
00mg
dated : 1511-10
2.
Final
notice for
rectificatio
n
of
shortcomin
gs/
observatio
ns.
Aminopyrine.50m
g
8000/dated : 11Caffiene & Sodium 11-10

benzoate.20mg
Chlorpheiramine
meleate.2mg
Analgesic/
Antipyretic/
Antiallergic
Decontrolled
/- Pack of 10,
20, 50 &
100ml
Manufacturer
382. M/s
Indus
Pharma (Pvt)
Ltd.,
Plot
No.
26,
27,,64,65,66,
67, Sector27, Korangi
Industrial
Area
Karachi74900
Exnal Injection
10mg/ml
Injection
Each ml Contains:
Nalbuphine
Hydrochloride
10mg
(Opioid Analgesic)
Form 5
Rs.8000/17-06-2006
Dy. No. not
mentioned
Rs.12,000/07-06-2013
Dy. No. Not
mentioned
Rs.40,000/(fast track)
Rs. 70/- per
Ampoule
Rs.700/- per
10s (1ml
Ampoule)
NUBAIN
10mg/ml
Ampoule
Health Canada
NALBIN
10mg/ml
Global
cGMP certificate
dated
11th
December, 2013.
Sterile
Liquid
[Injections
(Ampoules) and
Infusions (Vials)].
Panel inspection
for
grant
of
additional
sections dated 24th
1.
Firm
has
proposed test for
oxidizable
substance
and
microscopic
particle count test
instead test for
total
organic
carbon and light
obscuration
particle
count
tests respectively.
1.
Deferred
for TOC
analyzer
and liquid
particle
counter.
2.
Final
notice for
rectificatio
n
of
shortcomin
gs/
observatio
ns.
165
383. M/s
Indus
Pharma (Pvt)
Ltd.,
Plot
No.
26,
27,,64,65,66,
67, Sector27, Korangi
Industrial
Area
Karachi74900
Exnal Injection
20mg/ml
Injection
Each ml Contains:
Nalbuphine
Hydrochloride
. 20mg
(Opioid Analgesic)
Form 5
Rs.8000/17-06-2006
Dy. No. not
mentioned
Rs.12,000/07-06-2013
Dy. No. Not
mentioned
Rs.40,000/(fast track)
Rs. 85/- per
Ampoule
Rs.850/- per
10s (1ml
Ampoule)
February, 2014.
Panel
recommended
grant of sections.
NUBAIN
20mg/ml
Ampoule
Health Canada
NALBIN
20mg/ml
Global
cGMP certificate
dated
11th
December, 2013.
Sterile
Liquid
[Injections
(Ampoules) and
Infusions (Vials)].
1.
Firm
has
proposed test for
oxidizable
substance
and
microscopic
particle count test
instead test for
total
organic
carbon and light
obscuration
particle
count
tests respectively.
1.
Deferred
for TOC
analyzer
and liquid
particle
counter.
2.
Final
notice for
rectificatio
n
of
shortcomin
gs/
observatio
ns.
Panel inspection
for
grant
of
additional
sections dated 24th
February, 2014.
Panel
recommended
grant of sections.
Case No.09: Cases defered for steroidal facility

Following applications were deffered by registration board till finalization of policy on
manufacturing areas of steroidal preparations. Registration board in its 248 th meeting finalized
following policy:
a. Products containing steroidal topical preparations like eye/ear drops, sterile eye ointment,
external preparations i.e. cream/ointment/gel, lotions, spray/aerosols, suppositories, vaginal
preparation, intra oral preparations, nasal drops etc shall be permitted for manufacturing in
general facility/area provided that manufacturers shall have segregated dispensing booths,
cleaning validation and controls studies for processes and adequate system to minimize the
potential risk of cross contamination.
b. Manufacturers already having registration of above products and are manufacturing these in
general facility areas shall provide segregated dispensing booths and will conduct cleaning
validation and controls studies for processes and will also provide adequate system to minimize
166
the potential risk of cross contamination in 06 months time and will inform Registration Board
and respective DRAPs office in due course of time about complying aforementioned directions.
c.Registration Board advised Pharmaceutical Evaluation & Registration Division to compile
cases deferred due to confirmation of segregated steroidal section of dosage forms mentioned
above for consideration of the Board in forthcoming meetings. All such manufacturers will now
submit an undertaking that they shall provide segregated dispensing booths and will conduct
cleaning validation and controls studies for processes and will also provide adequate system to
minimize the potential risk of cross contamination in 06 months time or before start of
commercial manufacturing of these drugs whichever is earlier. Manufacturer will inform Area
FID, DRAP after complying the aforementioned conditions.
d. Registration Board deliberated that as segregated manufacturing facility is required for the
manufacturing of steroidal injections, syrup and oral solid dosage forms (tablet, capsules,
granules etc), thus the Board decided to discuss instant point in forthcoming meeting.
Applications for steroidal preparation deferred in 243rd Meeting of Registration Board
S.No
Name of
firm(s)
384. M/s Sante
(Pvt) Ltd,
A-97,
S.I.T.E.
Super
Highway
Karachi.
Name of drug(s) &

Composition
Rhinase
Nasal Spray
Each ml contains:
Naphazoline
Nitrate.1.25 mg
Ephedrine
Hydrochloride.5.00 mg,
9 alpha-Fluoroprednisolone21 acetate..
0.025 mg
(Allergy Nasal Spray)
(Manufacturers Spec.s)
Formulations
already registered
1.Not provided
2.Rhinosone
(Schazoo Pharma)
3. Acceptable level
of GMP (09-05-13)
Decision
Deferred for clarification
of manufacturing facility
(steroid and Controlled
Drug) from Licensing
Section.
Applications for steroidal preparation deferred in 245th Meeting of Registration Board
385. M/S
Ray
Pharma Pvt.
Ltd.S-58,
Site, Karachi
1. Oral Dry
Powder
Genticyn BD
Cream
Topical
Each gm contains:
Gentamicin as
Form 5
New Section
03-04-2014
Dy. No.373 R&I
Rs.20,000
VALISONE G
0.1 / 0.1% Cream
Health Canada
BETAGENIC
0.1% / 0.1%
1)
Confirmation
of
manufacturing
facility
for
steroidal
Deferred for
confirmation
of
manufacturin
g facility for
steroidal
167
Suspension
(General)
2. Cream /
Ointment /
Gel
(General)
3.
Ophthalmic
Drops Sterile
(General)
Sulphate (0.1%)
.. 1.0mg
Betamethasone as
dipropionate
(0.1%) .
1.0mg
Topical
corticosteroid and
aminoglycoside
15 gm/ As Per
PRC
Atco
386. M/S
Ray Genticyn BD
Pharma Pvt. Cream
Ltd.S-58,
Topical
Site, Karachi
Each gm contains:
Gentamicin as
Sulphate (0.1%)
.. 1.0mg
Betamethasone as
dipropionate
(0.1%) .
1.0mg
Topical
corticosteroid and
aminoglycoside
Form 5
New Section
03-04-2014
Dy. No.373 R&I
Rs.20,000
15 gm/ As Per
PRC
VALISONE G
0.1 / 0.1% Cream
Health Canada
387. M/S
Ray Raydex-T
Pharma Pvt. Ophthalmic Drops
Ltd.S-58,
Sterile Ophthalmic
Site, Karachi
Suspension
Each ml contains:
Tobramycin U.S.P
3mg
Dexamethasone
USP
1mg
Anti
Bacterial/Steroid
combination
Form 5
New Section
03-04-2014
Dy. No. 384
Rs. 20,000/5ml/ Rs. 350/-
TOBRADEX
Ophthalmic
Suspension
0.1% / 0.3%
US FDA
BETAGENIC
0.1% / 0.1%
Atco
BRACIN D
0.1 / 0.3%
Atco
preparations
required.
However, firm
has informed
that steroidal
product will be
manufactured
in
dedicated
manufacturing
equipment
(Hobart A 2
France).
1)
Confirmation
of
manufacturing
facility
for
steroidal
preparations
required.
However, firm
has informed
that steroidal
product will be
manufactured
in
dedicated
manufacturing
equipment
(Hobart A 2
France).
1)
Confirmation
of
manufacturing
facility
requirements
for
steroidal
preparations
required.
However, firm
has informed
that steroidal
product
manufacturing
will
be
in
dedicated
equipment
under dedicated
laminar flow.
preparations.
Deferred for
confirmation
of
manufacturin
g facility for
steroidal
preparations.
Deferred for
confirmation
of
manufacturin
g
facility
requirements
for steroidal
preparations.
168
Applications for steroidal preparation deferred in 246th Meeting of Registration Board

S.No
Name of
firm(s)
388.
M/s Care
Pharmaceut
icals,
8Km,
Thokor
Raiwind
Road,
Lahore
389. M/s Atco
Laboratorie
s
(Pvt)
Limited
Karachi.
390.
Name of drug(s) &

Composition
1.Sinocare
2.Cream
3.Each gm contains:
Fluocinolone
acetonide..2.5mg
4.Corticosteroid
Formulations already
registered/ Int.
availibility
FDA: Generic
(Taro)
Decision
Deferred for confirmation of
steroidal section.
ADVOCORT
Ointment 0.1%
Fatty Advantan
Fatty Deferred for confirmation of
Ointment
of
CSL manufacturing facility for steroids.
Limited
(TGA
Each gram contains:
Approved)
Methylprednisolone
aceponate.1mg
Advantan of Bayer
Pakistan Karachi.
Synthetic corticosteroid
Manufacturer
ADVOCORT
0.1%
Ointment
Each gram contains:

Methylprednisolone
aceponate.1mg
Advantan Ointment of
CSL Limited (TGA
Approved)

manufacturing facility for steroids.
Advantan of Bayer
Pakistan Karachi
Synthetic corticosteroid
Manufacturer
Case No 10: Cases deferred for review of formulations

Following applications were deferred in the past for review of formulation or for confrmation in
reference regulatory authorities. PEC has reviwed these formulations and submitted for
consideration of registration board.
1. PIRACETAM 1GM /5ML SYRUP

International availability
Nootropil 33% Oral Solution
in glass bottle containing
Me too status
NOOTROPIL
1g/5ml
Remarks
The MHRA approved product is available as
33% oral solution whereas, firms have applied
169
125ml or 300ml solution
M/s UCB, Karachi
MHRA
CERIL
1g/ml
M/s Vision, Islamabad
Indication: Myoclonus of
cortical
origin
in
combination with other antimyoclonic therapies
20% formulations. Moreover, the said

formulation is only indicated for Myoclonus of
cortical origin in combination with other antimyoclonic therapies.
Dose: The daily dosage should begin at 7.2 g
increasing by 4.8 g every three to four days up
to a maximum of 24 g, in two or three subdoses.
(Ref: MHRA)
N.B: (Review committee has not recommended
the product for regsitatrion in 246th meeting of
registration board. However, Registration
Board discussed comments of stakeholders in
246th meeting and decided that Review
Committee will review these comments for
framing its final recommendation).
S.No
Name of
firm(s)
391. Wimits Pharmaceuticals Plot #
129 Sundar Industrial Estate,
Raiwind Road Lhr Pakistan.
(M-243)
392.
M/s.Searle Pakistan Limited,

Lahore.
(M-238)
393.
M/s. Mediways International,

Lahore
(M-239)
Name of drug(s) &

Composition
1. Actopil
2. Syrup
3. Each 5ml Contains:
Piracetam ... 1gm
4. Nootropics
Neuronal metabolic modulator
5. Wimits Specs
Leucetam Oral Liquid
Each 5ml contains:Piracetam1gm
(Central nervous system stimulant)
Neurotone Syrup
Each 5ml contains:-
Decision
Referred to review committee for
review of formulation
Referred
to
Committee
the
Review
Deferred for review committee as

the formulation is under review.
Piracetam 1.0gm
2. PIRACETAM 800MG TABLETS

Nootropil 800mg f/c tablets
Me too status
NOOTROPIL
Remarks
The MHRA approved product is only indicated for
170
800mg
M/s UCB
MHRA
Indication: Myoclonus of
cortical origin in combination
with other anti-myoclonic
therapies
NEVROPIL
800mg tablet
M/s Global
S.No
Name of
firm(s)
394. M/s.Searle Pakistan Limited,
Lahore.
(M-238)
395.
Myoclonus of cortical origin in combination with

other anti-myoclonic therapies.
(Ref: MHRA)
M/s.Wilshire Laboratories,
Lahore.
N.B: (Review committee has not recommended the

product for regsitatrion in 246th meeting of
registration board. However, Registration Board
discussed comments of stakeholders in 246th
meeting and decided that Review Committee will
review these comments for framing its final
recommendation).
Name of drug(s) &

Composition
Leucetam-800 Tablets
Each tablet contains:Piracetam..800mg
(Central nervous system stimulant)
Decision
Q-Fix Tablets 800mg

Each tablet contains:Piracetam (I.N.N)..800mg
(Nootropics)
Referred to the Review Committee
3. PIRACETAM 400MG TABLETS

Not found in 400mg
strength. Only 800 mg and
1200 mg strengths are
available.
Me too status
CEREMIN
400mg tablet
M/s Schazoo Laboratories
Remarks
The daily dosage should begin at 7.2 g increasing
by 4.8 g every three to four days up to a maximum
of 24 g, in two or three sub-doses. Treatment with
other anti-myoclonic medicinal products should be
maintained at the same dosage. Depending on the
clinical benefit obtained, the dosage of other such
medicinal products should be reduced, if possible.
(Ref. MHRA)
recommendation).
S.No
Name of
Name of drug(s) &
Decision
171
396.
firm(s)
M/s.Wilshire Laboratories, Lahore.
(M-238)
Composition
Q-Fix Tablets 400mg
Each tablet contains:Piracetam (I.N.N)
.400mg
(Nootropics)
Referred
to
Committee
the
Review
4. CEFPODOXIME PROXETIL CEFPODOXIME 100MG CAPSULES

Not found as capsule in
reference drug agencies.
Me too status
IPOD
100mg capsule
M/s Genome
Remarks
FDA approved brand Vantin is available as
100mg film coated tablet.
QINK
100mg capsule
M/s Wilshire Laboratories
S.No
Name of
firm(s)
397. M/s Wisdom Pharmaceuticals
Industry,
78-A, Industrial Estate
Hayatabad, Peshawar.
(M-243)
398.
M/s Agror Pharma,

Rawat.
Capsules (Ceph.)
(10 files)
(M-243)
Name of drug(s) &

Composition
Lordex Capsules
Each capsule contains:Cefpodoxime Proxetil
Cefpodoxime (U.S.P)100mg
(Cephalosporin)
(Manufacturers)
Rinox 100mg Capsules
Each capsule contains:Cefpodoxime
(as
Proxitell)
..100mg
(2nd Generation Cephalosporins)
Decision
international
availability
stringent regulatory agencies.

international availability in
stringent DRAs.
5. CEFPODOXIME 200MG CAPSULES

Not found as capsule in
reference drug agencies
S.No
Name of
Me too status
Not found
Remarks
FDA approved brand Vantin is available as
200mg film coated tablet.
Name of drug(s) &
Decision
172
of
in
firm(s)
399. M/s Agror Pharma,
Rawat.
Capsules (Ceph.)
(10 files)
(M-243)
Composition
Rinox 200mg Capsules
Each capsule contains:Cefpodoxime (as Proxitell)
...200mg

international availability in stringent
DRAs and confirmation of me-too
status.
6. PHOLCODINE 5MG + CHLORPHHENIRAMINE MALEATE 2MG /5ML SYRUP

BRONCALENE ADULTES
Me too status
DECOREX
M/s Obsons
M/s HEPATOUM, FRANCE
Remarks
chlorphnamine (malate de) ; pholcodine
Dose: 0,01300g/100 ml (0.65mg/5ml); 0,08g/100ml
(4mg/5ml)
chlorphnamine (malate
de) ; pholcodine
(Ref: ANSM France)
0,01300g/100 ml
(0.65mg/5ml); 0,08g/100ml
(4mg/5ml)
Oral Syrup
400. M/s Wisdom Pharmaceuticals

Industry,
78-A, Industrial Estate
Hayatabad, Peshawar.
(M-243)
Frodine
Syrup
Each 5ml contains:Pholcodine (B.P)5mg
Chlorphheniramine Maleate
(B.P)...2mg
(Antitpyretic, Histamine H1receptor antagonist)
(Manufacturers)
Deferred for confirmation of controlled

drug section and international
availability.
7. MONTELUKAST SODIUM BP EQ. TO MONTELUKAST 10MG CHEWABLE TABLETS

Not found in reference drug
agencies as 10mg chewable
tablet.
However, 10 mg film coated
tablets are available.
Me too status
Not confirmed
Remarks
Only 10 mg film coated tablets are approved by
refence agencies. Chewable tablets in 4mg and 5mg
strength are recommended for pediatric patients of
2-5 years and 6-14 years of age respectively.
(Ref: FDA, MHRA)
173
401.
M/s Herbion Pakistan

(Pvt.) Ltd., Kahuta
Road, Industrial
Triangle, Humak,
Rawalpindi-Islamabad.
(M-243)
Montecast 10mg Chewable Tablets

Each chewable tablet contains:Montelukast Sodium BP eq. to
Montelukast.10mg
(Antiasthmatic Agent (Leukotriene
Receptor antagonist)
Deferred for correction in master

formulation and confirmation of
402.
M/s. Metro
Pharmaceuticals Plot
#14, Street No.SS-2,
National Industrial
Zone, Rawat, Islamabad
(M-243)
1.Mekast 10mg chewable Tablets

2.Tablet
3. Each chewable Tablet contains:
Montelukast as (Sodium) . 10mg
4.
Bronchodilators
/
Anti-Asthma
Selective
/
Leukotriene
Receptor
Antagonist
Deferred
for
formulation by
Committee.
403.
M/s Rock
Pharmaceuticals
Laboratories (Pvt) Ltd.
134-B & 135-B,
Nowshera Industrial
Estate, Risalpur
(M-242)
Manufacturer
1. Montekast 10mg
2. Tablet
3. Each chewable tablet contains,
Montelukast Sodium equivalent to
Montelukast M.S . 10 mg
review
of
the Review
Review of formulation by review

committee. Already registered
formulations would also be
reviewed.
4. Leukotriene Receptor Antagonist
8. MONTELUKAST SODIUM 5MG/5ML DRY SUSPENSION

Not available in reference
drug agencies
Me too status
Not confirmed
Remarks
Montelukast is approved as 4-mg oral granules in sachet
dosage form.
The innovators instructions for administrations are as
follows:
The packet should not be opened until ready to use. After
opening the packet, the full dose (with or without mixing
with baby formula, breast milk, or food) must be
administered within 15 minutes. If mixed with baby
formula, breast milk, or food, SINGULAIR oral granules
must not be stored for future use. Discard any unused
portion. SINGULAIR oral granules are not intended to be
dissolved in any liquid other than baby formula or breast
milk for administration. However, liquids may be taken
subsequent to administration.
(Ref: US FDA)
174
404. M/s Herbion Pakistan (Pvt.)

Ltd., Kahuta Road, Industrial
Triangle, Humak, RawalpindiIslamabad.
(M-243)
405.
M/s. Metro Pharmaceuticals Plot

#14, Street No.SS-2, National
Industrial Zone, Rawat,
Islamabad
(M-243)
406.
M/s Rock Pharmaceuticals

Laboratories (Pvt) Ltd. 134-B &
135-B, Nowshera Industrial
Estate, Risalpur
Montecast 10mg Chewable Tablets

Each chewable tablet contains:Montelukast Sodium BP eq. to
Montelukast.10mg
(Antiasthmatic Agent (Leukotriene
Receptor antagonist)
Deferred for correction in master

formulation and confirmation of
1.Mekast 10mg chewable Tablets

2.Tablet
3. Each chewable Tablet contains:
Montelukast as (Sodium) . 10mg
4. Bronchodilators / Anti-Asthma
Selective / Leukotriene Receptor
Antagonist
Deferred
for
formulation by
Committee.
Manufacturer
1. Montekast 10mg
(M-242)
2. Tablet
3. Each chewable tablet contains,
Montelukast Sodium equivalent
to Montelukast M.S . 10
mg
review
of
the Review
Review of formulation by review

committee. Already registered
reviewed.
4. Leukotriene Receptor
Antagonist
9. MONTELUKAST SODIUM 4MG/5ML DRY SUSPENSION

drug agencies
Me too status
Not confirmed
Remarks
Montelukast is approved as 4-mg oral granules in
sachet dosage form.
The innovators instructions for administrations are
as follows:
The packet should not be opened until ready to
use. After opening the packet, the full dose (with or
without mixing with baby formula, breast milk, or
food) must be administered within 15 minutes. If
mixed with baby formula, breast milk, or food,
SINGULAIR oral granules must not be stored for
future use. Discard any unused portion.
SINGULAIR oral granules are not intended to be
175
dissolved in any liquid other than baby formula or

breast milk for administration. However, liquids
may be taken subsequent to administration.
(Ref: US FDA)
407. M/s. Jaskan Pharmaceuticals (Pvt)

Ltd, Plot No. 50, Sundar Industrial
Estate, Lahore.
(M-243)
Mytekan 4mg
Dry Suspension
Each 5ml contains:Montelukast Sodium eq. to
Montelukast..4mg
(Leukotriene Receptor
Antagonist)
Deferred for review of formulation by

review committee.
10. ISOTRETINOIN 20MG CAPSULES

Approved by reference drug
agencies as gelatin capsule
containing isotretinoin USP,
stearoyl macrogolglycerides,
soybean
oil,
sorbitan
monooleate
and
propyl
gallate.
Me too status
Roaccutane of M/s Roche,
Karachi (Soft Gel Capsules).
ACNO of M/s Pramount,
Islamabad.
ACNOGEN of M/s Rotex
Medica, Islamabad
Remarks
Isotretinoin degrades when exposed to light or
atmospheric oxygen. Batches of drug substance are
stored under argon and protected from light.
Therefore, a powder filled hard gelatin capsule or
tablet dosage form may not be stable.
Hard Gelatin Capsule: Absorica (isotretinoin), a
retinoid, is available in 10 mg, 20 mg, 30 mg and 40
mg hard gelatin capsules for oral administration.
Each capsule contains isotretinoin, stearoyl
macrogolglycerides,
soybean
oil,
sorbitan
monooleate and propyl gallate. Gelatin capsules
contain the following dye systems: 10 mg
iron oxide (yellow) and titanium dioxide; 20 mg
iron oxide (red) and titanium dioxide; 30 mg iron
oxide (yellow, red and black) and titanium dioxide;
and 40 mg iron oxide (yellow, red and black) and
titanium dioxide.
Soft Gelatin Capsule: Isotretinoin, a retinoid, is
available as Sotret in 10 mg, 20 mg, 30 mg, and 40
mg soft gelatin capsules for oral administration.
Each capsule contains butylated hydroxyanisole,
edetate disodium, hydrogenated soybean oil,
hydrogenated vegetable oil, iron oxide black,
soybean oil and white wax. Gelatin capsules
contain glycerin and parabens (methyl and propyl),
with the following dye systems: 10 mg - iron oxide
176
(red) and titanium dioxide; 20 mg - FD&C Red No.

3, FD&C Blue No. 1, and titanium dioxide; 30 mg FD&C Yellow No. 6, and titanium dioxide; 40 mg FD&C Yellow No. 6, D&C Yellow No. 10, and
titanium dioxide.
408. M/s Wenovo Pharmaceuticals

Taxila.
(M-246)
409.
M/s Agror Pharma,

Rawat.
Capsules (Ceph.)
(M-243)
410.
M/s.Reliance Pharma,Plot#8,
Street#S-8 National Industries
Zone,Rawat-Islamabad.
(M-242)
Isotriwen 20mg Capsules

Each capsule contains:Isotretinoin20mg
(Cystic Acne)
Referred for review of formulation

by review committee.
Isotretinor 20mg Capsules

Each capsule contains:Isotretinoin..20mg
(Vit A Derivative / Anti Acne
Preparation)
BP
1.Isorel
Referred to Review committee for

review of formulation.
2. Capsule
3.
Each
Capsule
contains:
Isotretinoin..20
mg
4.Vitamin A Derivative
411.
M/s Welmark Pharmaceuticals,

Hattar.
(M-242)
1. Trionin
2. Capsules
3. Each capsule contains:Isotretinoin..20mg
4. (anti Acne)
412.
M/s. Global Pharmaceuticals

(Pvt) Ltd Plot # 204-205,
Industrial Triangle, Kahuta
Road, Islamabad
1.Isonig
(M-242)
Isotretinoin 20mg
2.Capsule
3. Each Capsule contains:
2.Capsule
Deferred for review of formulation

since the reference formulation as
approved
by
the
Stringent
Regulatory Agencies is in Soft
gelatin capsule or hard gelatin
containing
oleaginous
bases.
Already available formulations
would also be reviewed.
since the formulation is in soft
gelatin capsules or hard gelatin
capsules with oleageneous bases as
approved by stringent regulatory
agencies like FDA. Already
available formulations would also
be reviewed.
as the formulation approved by the
stringent regulatory authorities is in
soft gel capsules or hard gelatin
containing
oleaginous
bases.
Already available formulations
would also be reviewed.
177
4. Anti-Acne
413.
M/s Synchro Pharmaceuticals,

77- Industrial Estate, Kot
Lakhpat, Lahore.
1. Isorex
(M-242)
3.Each capsule contains Isotretinoin

BP 20mg
2. Capsule
4. Vitamin A derivative
414.
M/s.
Weather
Fold1.
Daxar20mg Tablets
Each tablet contains:Pharmaceuticals, Plot No. 69/2,2.
Isotretinoin..20mg
Phase-II,
Industrial
Estate,
Hattar
3. Cystic acne
(M-242)
415.
M/s.
Winbrain
Research 1. Aleprozil 20mg Tablets
Laboratories, Plot No. 69/1,
Block B, Phase I-II, Industrial 2.Each tablet contains:Estate, Hattar.
Isotretinoin..20mg
(M-242)
3. Cystic Acne
Deferred for completion of Form 5

& also the formulation is under
review since reference formulation
as approve by stringent regulatory
agencies is in soft gelatin capsule or
hard gelatin capsule containing
oligenouse bases. Already available
reviewed.
Deferred
for
review
of
formulation / dosage form as the
product is approved by stringent
regulatory authorities as soft gelatin
capsules or hard gelatin capsules
with oleaginous bases. Already
be reviewed.
Deferred
for
review
of
formulation / dosage form as the
product is approved by stringent
regulatory authorities as soft gelatin
capsules or hard gelatin capsules
with oleaginous bases. Already
be reviewed.
11. ISOTRETINOIN 10MG CAPSULES

Approved by reference drug
agencies as gelatin capsule
containing isotretinoin USP,
stearoyl macrogolglycerides,
soybean
oil,
sorbitan
monooleate
and
propyl
gallate.
Me too status
Roaccutane of M/s Roche,
Karachi (Soft Gel Capsules).
ACNO of M/s Paramount,
Islamabad.
ACNOGEN of M/s Rotex
Medica, Islamabad
Remarks
Isotretinoin degrades when exposed to light or
atmospheric oxygen. Batches of drug substance are
stored under argon and protected from light.
Therefore, a powder filled hard gelatin capsule or
tablet dosage form may not be stable.
Hard Gelatin Capsule: Absorica (isotretinoin), a
retinoid, is available in 10 mg, 20 mg, 30 mg and 40
mg hard gelatin capsules for oral administration.
Each capsule contains isotretinoin, stearoyl
macrogolglycerides,
soybean
oil,
sorbitan
monooleate and propyl gallate. Gelatin capsules
178
contain the following dye systems: 10 mg

iron oxide (yellow) and titanium dioxide; 20 mg
iron oxide (red) and titanium dioxide; 30 mg iron
oxide (yellow, red and black) and titanium dioxide;
and 40 mg iron oxide (yellow, red and black) and
titanium dioxide.
Soft Gelatin Capsule: Isotretinoin, a retinoid, is
available as Sotret in 10 mg, 20 mg, 30 mg, and 40
mg soft gelatin capsules for oral administration.
Each capsule contains butylated hydroxyanisole,
edetate disodium, hydrogenated soybean oil,
hydrogenated vegetable oil, iron oxide black,
soybean oil and white wax. Gelatin capsules
contain glycerin and parabens (methyl and propyl),
with the following dye systems: 10 mg - iron oxide
(red) and titanium dioxide; 20 mg - FD&C Red No.
3, FD&C Blue No. 1, and titanium dioxide; 30 mg FD&C Yellow No. 6, and titanium dioxide; 40 mg FD&C Yellow No. 6, D&C Yellow No. 10, and
titanium dioxide.

Rawat.
Capsules (Ceph.)
(10 files)
(M-243)
417.
M/s. Global Pharmaceuticals

(Pvt) Ltd Plot # 204-205,
Industrial Triangle, Kahuta
Road, Islamabad
(M-242)
Isotretinor 10mg Capsules

Each capsule contains:Isotretinoin..10mg
(Vitamin A Derivative / Anti
Acne Preparation)
BP
1.Isonig
2.Capsule
3. Each Capsule contains:
Isotretinoin 10mg
Referred to Review committee for review

of formulation.
Deferred for review of formulation as the

formulation approved by the stringent
regulatory authorities is in soft gel
capsules or hard gelatin containing
oleaginous bases. Already available
formulations would also be reviewed.
4. Anti-Acne
12. AZITHROMYCIN 500MG CAPSULES

Not approved in reference
drug agencies. Only 250 mg
capsules
are
approved.
Me too status
AZOGEN of M/s Rogen,
Islamabad.
AZOTINE of M/s Nimral
Remarks
When azithromycin capsules were administered
with food, the rate of absorption (Cmax) of
azithromycin was reduced by 52% and the extent of
179
However, 500 mg tablets are

available.
Pharma, Islamabad
Zithromax 250 mg capsules should be given as a

single daily dose. In common with many other
antibiotics Zithromax Capsules should be taken at
least 1 hour before or 2 hours after food.
(Ref: MHRA)
Zithromax of M/s Pfizer,

UK.

Taxila.
(M-243)
419. M/s. Wellness Pharmaceuticals (Pvt)

Ltd, Plot No. 33 Sunder Industrial
Estate, Lahore.
(M-243)
absorption (AUC) by 43%.
Azrovo 500mg Capsules

Each capsule contains:Azithromycin500mg
(Macrolide antibiotics)
USP
Myzit 500mg


review of formulation
Capsule
Each Capsule contains:Azithromycin500mg
Antibiotic
Manufacturers Specifications
420. M/s. Navegal Laboratories, 41/1-A2,

Phase-1 , Industrial Estate, Hattar.
(M-243)
421. M/s Umema Pharma

Plot No. M-28, Hub Industrial Estate,
Balochistan
(M-244)
1. Azifast 500mg Capsules

2. Each capsule contains:Azithromycin
Dihydrate
524mg
equivalent
to
Azithromycin (U.S.P)...500mg
3.A
Nitrogen-Containing
Marrolide
Azoum Capsules 500 mg
Each capsule contains
Azithromycin dihydrate USP
eq to Azithromycin .. 500
mg
(Macrolide Antibiotic)
Finished product specifications
are USP.

review of all registered products.

international
availability
Stringent Regulatory Agencies.
180
of
in
13. DEXIBUPROFEN 100MG/5ML SUSPENSION

drug agencies.
422. M/s
Wenovo
Pharmaceuticals
Taxila.
Me too status
Dexib of Tabros
Karachi
Pharma
Remarks
Not approved in reference drug agencies.
Wedexi Suspension
Each 5ml contains:Dexibuprofen .100mg
(non-steroidal anti-inflammatory drug
with analgesic action)
Deferred for confirmation international

availability in stringent DRAs.
14. LEVOFLOXACIN 125MG/5ML DRY POWDER SUSPENSION

agencies. Drug is available
only in USFDA in the form
of Oral Solution, 25 mg/mL.
Levaquin of M/s Janssen
Pharms USA.
423. M/s
Pharmaceuticals
Taxila.
(M-243)
Me too status
LEVANIC of M/s Global
EVERFLOX of M/s Everest
LEVOR of M/s Medera
Wenovo
424.
M/s Agror Pharma,

Rawat.
(M-243)
425.
M/s Hiranis Pharmaceutical

Pvt. Ltd. Plot.No. E-145149,
North
western
Industrial Zone, Port Qasim,
Karachi.
(M-246)
Remarks
Drug is available only in USFDA in the form of
Oral Solution, 25 mg/mL, which is a multi-use selfpreserving aqueous solution of levofloxacin with
pH ranging from 5.0 to 6.0. The appearance of
Levofloxacin Oral Solution may range from clear
yellow to clear greenish-yellow. This does not
adversely affect product potency.
Wenlevo 125mg Suspension

Each 5ml contains:Levofloxacin
hemihydrate..125mg
(Anti-Infective, Quinolone)
as
Deferred for clarification of formulation

as applied formulation is approved in
solution form in stringents DRAs
Levonor 125mg Dry Suspension

Each 5ml contains:Deferred for clarification of formulation
Levofloxacin (as Hemihydrate) from Firm as applied formulation is
125mg
approved as solution in stringent DRAs.
(Quinolone antibiotic)
Manufactrure
Levopearl
Dry Suspension
Each 5ml contains:Levofloxacin USP 125 mg
Quinolone
Deferred for confirmation of formulation.
181
426.
M/s. Medisearch Pharmacal

(Pvt) ltd, 5-Km, Raiwind
Manga Road, Lahore.
(M-243)
427.
M/s. Jaskan
Pharmaceuticals (Pvt) Ltd,
Plot No. 50, Sundar
Industrial Estate, Lahore.
(M-243)
428.
M/s Sami Pharmaceuticals

(Pvt) Ltd., F-95, Off. Hub
River
Road,
S.I.T.E.,
Karachi.
(M-246)
are Manufacturer.
Levosrch 125mg
Supension
Each 5ml contains:Levofloxacin Hemihydrates eq to
Levofloxacin 125mg
(Quinolone/antibiotics, systemic)
Levokan 125mg
Dry Suspension
Each 5ml contains:Levofloxacin.125mg
(Quinolone)
1. EFFIFLOX 125 mg/5ml

2. Dry powder suspension 3. Each
5ml of reconstituted suspension
contains:
Levofloxacin
Hemihydrate
MS
eq.
to
Levofloxacin
..
125mg
4. Fluroquinolone.

by firm as the applied product is in
solution form in stringent DRAs

from firm as applied product is approved
as solution in stringent DRAs
The Board did not accede to the request of

firm for change in dosage form &
deferred the instant application for review
of formulation by Incharge, PEC...
15. LEVOFLOXACIN 250MG/5ML DRY POWDER SUSPENSION

agencies. Drug is available
only in USFDA in the form
of Oral Solution, 25 mg/mL.
Levaquin of M/s Janssen
Pharms USA.
Me too status
LEVOLEX Suspension of
M/s Jawa
LEVANIC of M/s Global
EVERFLOX of M/s Everest

Taxila.
(M-243)
Remarks
Drug is available only in USFDA in the form of
Oral Solution, 25 mg/mL,which is a multi-use selfpreserving aqueous solution of levofloxacin with
pH ranging from 5.0 to 6.0. The appearance of
Levofloxacin Oral Solution may range from clear
yellow to clear greenish-yellow. This does not
adversely affect product potency.
The drug is also available locally as dry powder
suspension 500mg/5ml.
Wenlevo 250mg Suspension

Each 5ml contains:Levofloxacin
as
hemihydrate..250mg
(Anti-Infective, Quinolone)
Deferred for clarification of

formulation as applied formulation is
approved in solution form in
stringents DRAs
182
430.
M/s Agror Pharma,

Rawat.
Capsules (Ceph.)
(M-243)
Levonor 250mg Dry Suspension

Each 5ml contains:Levofloxacin (as Hemihydrate)
250mg
(Quinolone antibiotic)
431.
M/s Hiranis Pharmaceutical Pvt.

Ltd. Plot.No. E-145-149, North
western Industrial Zone, Port
Qasim, Karachi.
(M-244)
432.
M/s. Medisearch Pharmacal (Pvt)

ltd, 5-Km, Raiwind Manga Road,
Lahore.
(M-243)
433.
M/s. Jaskan Pharmaceuticals

(Pvt) Ltd, Plot No. 50, Sundar
(M-243)
434.
M/s Sami Pharmaceuticals (Pvt)

Ltd., F-95, Off. Hub River Road,
S.I.T.E., Karachi.
(M-246)
Levopearl -DS
Dry Suspension
Each 5ml contains:Levofloxacin USP 250 mg
Quinolone
are Manufacturer.
Levosrch 250mg
Suspension
Each 5ml contains:Levofloxacin Hemihydrates eq
to Levofloxacin 250mg
(Quinolone/antibiotics,
systemic)
Levokan 250mg
Dry Suspension
Each 5ml contains:Levofloxacin.250mg
(Quinolone)
1. EFFIFLOX 250 mg/5ml
2. Dry powder suspension
3. Each 5ml of reconstituted
suspension
contains:
Levofloxacin Hemihydrate MS
eq.
to
Levofloxacin
.. 250mg
4. Fluroquinolone.
Capule for is not available in
reference agencies. Only
tablet dosage form exists.
Deferred
for
clarification
of
formulation from Firm as applied
formulation is approved as solution in
stringent DRAs.
formulation
for
international
availability.
Deferred
for
clarification
of
formulation by firm as the applied
product is in solution form in
stringent DRAs
Deferred
for
clarification
of
formulation from firm as applied
product is approved as solution in
stringent DRAs
The Board did not acceed the request
of firm for change in dosage form &
deferred the instant application for
review of formulation by Incharge,
PEC.
16. LEVOFLOXACIN 250MG CAPSULES

Me too status
Remarks
BEXUS of M/s Shaigan, Isb
Levofloxacin is approved in tablet dosage form by
GLIT of M/s SJ&G, Lhr
E-LEV of M/s English, Khi.
435. M /s. Aries

Pharmaceuticals,Peshawa
Levocap Capsules 250

mg
The Board referred products to review

committee for evaluation and
183
Each capsule contains:-
(M-239)
Levofloxacin
recommendation
Hemihydrate
Levofloxacin .250
mg
(Quinolone)
436.
M/s. Jeans
Pharmaceutical, Lahore
(M-239)
Levojaens 250mg Capsules.

Each Capsule contains:Levofloxacin as
Hemihydrate..250mg.
Deferred for review committee
17. LEVOFLOXACIN 500MG CAPSULES

Capule for is not available in
reference agencies. Only
tablet dosage form exists.
437.
Me too status
BEXUS of M/s Shaigan, Isb
GLIT of M/s SJ&G, Lhr
E-LEV of M/s English, Khi.
M /s. Aries
Levocap Capsules 500
Pharmaceuticals,
mg
Peshawar
(M-239)
Levofloxacin Hemihydrate
Remarks
Levofloxacin is approved in tablet dosage form by
The Board referred products to

review committee for evaluation
and recommendation
Levofloxacin .500
mg
(Quinolone)
438.
M/s. Jeans
Pharmaceutical,
Lahore
(M-241)
Levojaens 500mg Capsules.

Each Capsule contains:Levofloxacin as Hemihydrate..500mg
Deferred for review committee
18. CIPROFLOXACIN AS HCL 125MG DRY SUSPENSION

184
agencies.
Me too status
NOVIDAT of M/s Sami
CIPRIN of M/s Werrick
HIFLOX of M/s Hilton
Remarks
Ciprofloxacin Oral Suspension is available in
250mg/5 ml and 500mg/5 ml strengths.
Adults: : 250 mg twice daily to 750 mg twice daily
depending upon nature and severity of infection.
Peads: 1 year (PO): 10-20 mg/kg q12hr;
individual dose not to exceed 750 mg q12hr (UTI).
Decscription:
Ciprofloxacin Oral Suspension is a white to slightly
yellowish suspension with strawberry flavor which
may contain yellow-orange droplets.
It is composed of ciprofloxacin microcapsules and
diluent which are mixed prior to dispensing .
The components of the suspension have the
following compositions:
Microcapsulesciprofloxacin,
povidone,
methacrylic acid copolymer, hypromellose,
magnesium stearate, and Polysorbate 20.
Diluentmedium-chain triglycerides, sucrose,
lecithin, water, and strawberry flavor.
Five (5) mL of 5% suspension contains
approximately 1.4 g of sucrose and 5 mL of
10% suspension contains approximately 1.3 g
of sucrose.

Taxila.
(M-243)
440.
M/s Agror Pharma,

Rawat.
Capsules (Ceph.)
(M-243)
Novocip 125mg Dry Suspension

Each 5ml contains:Ciprofloxacin as HCl125mg
(Anti-bacterial Quinolones)

approval of formulation in
125
mg
strength
by
Stringent
Regulatory
Agencies.
Cipronor 125mg Dry Suspension

Each 5ml contains:Ciprofloxacin (as HCl)..125mg
(Quinolone Antibiotic)

approval of formulation in 125
mg strength by Stringent
Regulatory Agencies.
Ciprofloxacin taste masked pellets

25%
Source: Vision
Islamabad
Pharmaceuticals
Manufacturer
441.
INFEXO

185

Qasim, Karachi.
(M-243 & M-244)
442.
M/s Searle IV Solutions (Pvt.) Ltd,

1.5 km Manga Raiwind Road,
Manga Mandi, Lahore
(M-243)
443.

Lahore.
(M-243)
444.
M/s. Jaskan Pharmaceuticals (Pvt)

Ltd, Plot No. 50, Sundar Industrial
Estate, Lahore.
(M-243)
445.
M/s Martin Dow Ltd. Plot.No.37,

Sector 19, Korangi Industrial Area
Karachi.
(M-244)
446.

Qasim, Karachi.
(M-244)
447.
M/S Pharma Lord (Pvt) Ltd., 12

Km, Lahore Road, Layyah.
Dry Suspension
Each 5ml contains:
Ciprofloxacin USP 125mg
(Quinolone)
Finished product specifications are
Manufacturer
Ciroxin 125mg
Dry Suspension
Each 5ml (when reconstituted)
contains:Ciprofloxacin (as hydrochloride)
BP.125mg
(Quinolone (anti-infective,
systemic)

Becip 125mg
Suspension
Each 5ml contains:Ciprofloxacin HCl eq. to
Ciprofloxacin125mg
(Quinolone)
Ciprokan 125mg
Dry Suspension
Each 5ml contains:Ciprofloxacin Hydrochloride (USP)
eq. to Ciprofloxacin.125mg
(Quinolone)
(USP)
BOXIN DRY SUSPENSION
125mg/5ml
Each 5ml suspension contains:
Ciprofloxacin as Hcl
125mg
Ciprofloxacin taste masked
granules 35%
Source: Vision Pharmaceuticals
Islamabad
Manufacturers specifications
INFEXO
Dry Suspension
Each 5ml contains:
(Quinolones)
Manufacturer
CPRO 125mg/5ml Suspension




stringent DRAs.

international availability.
Deferred
for
formulation.
review
186
of
Tablet (General)
Capsule (General)
Oral Dry Powder Suspension
(General)
(M-246)
Dry Suspension
Each reconstituted 5ml contains:
Ciprofloxacin ..... 125mg
(Anti-infective / Quinolone)
448.
M/s CCL Pharmaceuticals, Pvt.

Ltd.
62-Industrial Estate, Kot Lakhpat,
Lahore
(M-246)
1.Cip
2.Suspension
Ciprofloxacin hydrochloride eq. to
ciprofloxacin..................125mg
4.Antibiotic.
Deferred
for
review
of
formulation
by
Review
Committee.

agencies.
Me too status
NOVIDAT of M/s Sami
Remarks
Description:
Ciprofloxacin Oral Suspension is available in 5%
(5 g ciprofloxacin in 100 mL) and 10% (10 g
ciprofloxacin in 100 mL) strengths. Ciprofloxacin
Oral Suspension is a white to slightly yellowish
suspension with strawberry flavor which may
contain yellow-orange droplets.
povidone,
of sucrose.
187
449. M/s Hiranis Pharmaceutical

Pvt. Ltd. Plot.No. E-145-149,
North western Industrial Zone,
Port Qasim, Karachi.
(243 & 244)
450.
M/s
Sigma
Pharma
International Pvt. Limited E50, N.W.I.Z., Port Qasim
Karachi
(M-246)
451.
M/s MTI Medical (Pvt)

Limited, 586-587 Sunder
Industrial Estate, Raiwind
Road Lahore.
(M-246)
INFEXO DS
Dry Suspension
Each 5ml contains:
(Quinolones)
are Manufacturer
Cip 250mg/5ml
Dry Suspnsion
Each 5ml contains:Ciprofloxacin
(as
Ciprofloxacin
HCl
Monohydrate) 250mg
( Quinolones Antibiotic )
CYTO Suspension
Deferred for confirmation / clarification

of formulation.
Deferred till review of formulation by

Review Committee

Review Committee.
Each 5ml contains:

Ciprofloxacin as HCL taste
masked pellets 25% equivalent
to Ciprofloxacin....250mg
Fluoroquinolone
Manufacturer
20. CIPROFLOXACIN LACTATE EQUIVALENT TO CIPROFLOXACIN 400MG/ 100ML

INFUSION
agencies. Available in 2 mg/
ml strength only.
Me too status
CIPLET of M/s Indus
NOVIDAT of M/s Sami
MYTIL of M/s Wilson
452. M/s Rasco Pharma, 5.5 Km

Raiwind Road, Lahore
(M-246)
Remarks
Ciprofloxacin (as lactate) solution for infusion is
approved in TGA and is supplied in transparent
infusion bags (PVC or polyolefin) containing 50ml,
100ml or 200ml of sterile solution of ciprofloxacin
2 mg/ml whereas the applied strength is 4mg/ml.
CIP-RX Infusion
Each 100ml vial contains:
Ciprofloxacin lactate equivalent to
Ciprofloxacin USP.400mg
Deferred for confirmation of approval of

formaulation in Stringent Regulatory
Agencies in the same strength.
188
Quinolone
USP
21. CIPROFLOXACIN 250 MG CAPSULES

Capules dosage form is not
available
in
reference
agencies.
Me too status
EVOFLOX of M/s
Paramount
CIPRGEN Of M/s Genra
CIPFAZ of M/s Genome
453. Rogen Pharmaceuticals.
Remarks
Ciprofloxacin tablets are approved in reference
agencies.
Rocep 250 mg Capsule
Deferred for review of

formualation by Review
Committee.
Plot No. 30, St No. S-4
National Industrial Zone (RCCI),

Rawat, Islamabad.
Ciprofloxacin HCL USP 250 mg
(M-246)
(Quinolone)
Manufacturer
22. CIPROFLOXACIN 500 MG CAPSULES

Capules dosage form is not
available
in
reference
agencies.
454.
Me too status
EVOFLOX of M/s
Paramount
CIPRGEN Of M/s Genra
CIPFAZ of M/s Genome
Remarks
Ciprofloxacin tablets are approved in reference
agencies.
Rogen Pharmaceuticals.
Rocep 500 mg Capsule
National Industrial Zone

(RCCI), Rawat, Islamabad.
Ciprofloxacin HCL 500 mg
(M-246)
Deferred for review of formualation by

Review Committee.
(Quinolone)
Finished product
specifications are
189
Manufacturer
23. CEFIXIME 200MG CAPSULES

Capsule 200mg is not
available
in
reference
agencies. Howeve, 200mg
film
coated
tablet
is
available
in
MHRA.
(Suprax, Sanofi, UK).
Me too status
CEFIM of M/s Hilton
CEFIX of M/s Stand Pharm
WEXIME of M/s Wnsfield

Taxila.
(M-243)
Remarks
Cefixime 200mg capsules are not approved in
reference agencies. However, the recommended
dose of cefixime is 400 mg daily. This may be given
as a 400 mg tablet or capsule daily or the 400 mg
tablet may be split and given as one half tablet
every 12 hours. The capsule and tablet may be
administered without regard to food.
(Ref: FDA)
Wenoxime 200mg Capsules

Each capsule contains:Cefixime 200mg
Antibiotic, Cephalosporine)
Deferrred for confirmation of

stringent DRAs.
manufacturer
456.
M/s Agror Pharma,

Rawat.
Capsules (Ceph.)
(10 files)
(M-243)
Agrofix 200mg Capsules

Each capsule contains:Cefixime (as trihydrate).200mg
(Third Generation Cephalosporins)

stringent DRAs.
Manufacturer
457.

Lahore.
(M-243)
Medicef 200mg
Capsule
Each capsule cotnains:Cefixime Trihydrate
Cefixime (U.S.P)..200mg
(Cephalosporin)
(Manufacturers)

stringent DRAs
24. CEFADROXIL 250MG CAPSULES

Me too status
Remarks
190
250mg
capusule
Not
available
in
reference
agencies.
458.
M/s
Pharmaceuticals
Taxila.
(M-243)
ROXIL of M/s Jawa

ULTROXIL of M/s Himont
FASIROX of M/s Fassgen
Wenovo
The applied formulation has been discontinued

by the USFDA. However the 500mg capsules
are available.
Dose Adults: 1000mg per day to twice a day.
Dose Children: For younger children and
children with a body weight < 40 kg, liquid oral
forms (Cefadroxil 250 mg/ 5 ml granule for
oral suspension) are available.
(Ref: MHRA)
Cefdox 250mg Capsules

Each capsule contains:Cefadroxil.250mg
(Antibiotic, Cephalosporine)
Deferrred for confirmation of international

Mannufacturer
25. CEFADROXIL 1GM CAPSULES

Cefadroxil 1 gm capsule is
not available in reference
agencies. However, 1 gm
tablet is available in FDA,
MHRA.
459.
460.
Me too status
CEFDIL of M/s Alina
Combine, Karachi
DURICEF of M/s GSK,
Karachi
MEDICEF of M/s Mediate,
Karachi.
Remarks
The applied formulation is not approved in any
reference agencies however 1gm tablet is USFDA
approved. Cefadroxil is available as 500mg
capsules and tablets
Dose Adults: 1000mg per day to twice a day.
Dose Children: For younger children and children
with a body weight < 40 kg, liquid oral forms
(Cefadroxil 250 mg/ 5 ml granule for oral
suspension) are available.
(Ref: MHRA)
M/s
Wenovo
Pharmaceuticals
Taxila.
(M-243)
Cefdox 1gm Capsules

Each capsule contains:Cefadroxil.1gm
(Antibiotic, Cephalosporine)
Deferrred for confirmation of international

M/s.
Medisearch
Pharmacal (Pvt) ltd, 5-
Chemidroxil 1gm
Capsule
Deferred for confirmation of international

availability
191
Km, Raiwind Manga

Road, Lahore.
(M-243)
Each capsule contains:Cefadroxil Monohydrate eq. to

Cefadroxil (U.S.P)1gm
(Cephalosporin)
(U.S.P)
26. CEFUROXIMEAXITEL 250MG CAPSULES

agencies. However, tablet
dosage form is available.

Rawat.
Capsules (Ceph.)
(10 files)
(M-243)
Me too status
DAYCEF of M/s Sharooq
CEFUSAVE of M/s Medisave
LYCTIN of M/s Caraway
Remarks
The formulation is not approved in any reference
agencies. Tablet dosage form is available only.
Cefrox 250mg Capsules

Each capsule contains:Cefuroxime (as Axitel).250mg

Manufacturer specs
27. CEFUROXIME 1GM POWDER FOR INJECTION

agencies.
Me too status
EZOXO of M/s English
OPTIK of M/s Wilshire
TRUCEF of M/s Synchro
462. M/s. Medisearch Pharmacal

(Pvt) ltd, 5-Km, Raiwind
Manga Road, Lahore.
(M-243)
Remarks
The formulation is not approved in any reference
agencies. 750mg & 1.5g dry powder vials are
available
Dose: 750mg q 8 hourly for CAP, 1.5gmg q 8
hourly for complicated UTI.
Furains 1gm Powder for

injection Injection
Each vial contains:Cefuroxime Sodium eq. to
Cefuroxime.1gm
(Cephalosporin)
(USP Spec.s)

192
28. RABEPRAZOLE 20 MG CAPSULES

agencies.

Rawat.
Capsules (Ceph.)
(M-243)
Me too status
Rabiton of Envoy Pharma
Lahore
Remarks
Recommendation: May not be approved.
Rabinor 20mg Capsules

Each capsule contains:Rabeprazole (as Sodium enteric coated
pellets).20mg
(Proton Pump Inhibitor)

international availability in stringent
DRAs.
(Manufacturer)
Source: Spansule Formulations, Sy No
172, Plot No, 154/A4, IDA, Bollaram
Village,
Jinnaram
Mandal,Medak
District, Andra Pardesh, India
agencies.
464. M/s Bosch Pharma
Kar.
(M-244)
29. RABEPRAZOLE 20 MG INJECTION

Me too status
Remarks
RABZ of M/s Wilshire, Recommendation: May not be approved.
Lahore.
1.Rabosh 2.Injection
3.Each vial contains:
Rabeprazole Sodium..20 mg
4.Gastric acid pump inhibitor
Deferred
for
confirmation
international availability.
30. CINITAPRIDE 1MG TABLETS

International Availability
Me-too Status
Remarks
Spain: BLASTON 1 mg COMPRIMIDOS

(Tablets)
,
CIDINE 1 mg COMPRIMIDOS
(Reference :Agencia Espaola de
Medicamentos y Productos Sanitarios)
Cinita
1mg
(GETZ
PHARMA
PAKISTAN
(PVT) LTD.)
CIDINE
(HIGHNOON
LABORATORIES LTD.)
CINRIDE
(GENIX
PHARMA (PVT) LTD)
Drug is available in Spain.

(Reference :Agencia
Espaola de Medicamentos
y Productos Sanitarios)
193
of
465. M/s Hiranis Pharmaceutical Pvt.

Qasim, Karachi.
(Tablet General)
(M-243 & 244)
466.
M/s WnsFeild Pharmaceuticals,

Hattar.
(M-242)
Gastopride
Tablet
Cinitapride as Acid
Tartrate MS 1mg
(Prokinetic)
Finished
product
specifications
are
Manufacturer.
1. Cinride
2. Tablets
Referred to Review Committee for

review of formulation.

Review Committee.
3. Each film coated table

contains:Cinitapride.1mg
4. (Anti Ulcer)
(The
tablet
was
mentioned as uncoated
in the agenda now it has
been corrected as film
coated.)
467.
M/s Semos Pharmaceuticals (Pvt)

Plot No. 11, Sector 12-A North
Karachi, Karachi-75850, Pakistan
(M-242)
468.
M/s Saibins Pharmaceuticals, Plot

No.316 Industrial Triangle, Kahuta
Road, Islamabad
(M-242)
1. Pemix 1mg
2. Tablets
3. Each film coated
tablet contains:Cinitapride
Hydrogen
Tartrate
eq.
to
Cinitapride 1mg
4. (Gastroprokinetic)
1.C-Pride 1mg Tablets
2. Tablet

by Review Committee.
Deferred for reviw of formulation by

review committee
3. Each film coated

Tablet contains:
Cinitapride .. 1mg
4. Gastrointestinal drugs
469.
M/s. Navegal Laboratories,
1. Reflux 1mg 2.Tablets
41/ 1- A-2, Phase-1, Industrial
3.
Each film coated
Deferred for consideration by

Review Committee
194
470.
Estate,
tablet contains:-
Hattar
Cinitapride.1mg
(M-242)
4.
Gastroprokinetic
agent and antinuclear
agent of the benzamide
class
M/s Pharmix Laboratories (Pvt.)

Ltd.
1. Cpride
21-Km Ferozpur Road, Lahore.

(M-242)
2. Tablet

review Committee
3. Each tablet contains

Cinitapride (Hydrogen
Tartrate) 1 mg
4. Gastroprokinetic
Spain: BLASTON 1 mg/5ml
SOLUCION ORAL
31. CINITAPRIDE 1MG/5ML SYRUP

Me-too Status
Remarks
CIDINE
(HIGHNOON
LABORATORIES LTD.)
Drug is available in Spain.

(Reference :Agencia Espaola
de Medicamentos y Productos
Sanitarios)
CINPRIDE
(KAIZEN
PHARMACEUTICALS
PVT
LTD.)
471.
M/s Hiranis Pharmaceutical

Pvt. Ltd. Plot.No. E-145-149,
North western Industrial Zone,
Port Qasim, Karachi.
(M-243 & 244)
472.
M/s High-Q, Karcahi

(M-242)
Gastopride
Syrup
Each 5ml contains:Cinitapride as acid Tartrate
MS 1mg
(Prokinetic)
Finished
product
specifications
are
Manufacturer.
Cint 1mg/5ml Syrup
Each 5ml contains:
Deferred for review of formulation.

Review Committee keeping in view
status in stringent drug regulatory
bodies
195
Cinitapride as acid tartarate..

1 mg
473.
M/s Fynk Pharmaceuticals,

Plant:19Km G.T. Road,
Kalashah Kaku, Lahore
(M-242)
1. Cinic
2. Syrup
3. Each 5ml syrup contains:
Cinitapride (as Hydrogen
tartrate) .. 1mg

Review Committee
4. Gastroprokinetics
474.
M/s Semos Pharmaceuticals

(Pvt) Plot No. 11, Sector 12-A
North Karachi, Karachi75850, Pakistan
(M-242)
1. Pemix
2.Syrup
3. Each 5ml contains:Cinitapride Hydrogen Tartrate
eq. to Cinitapride 1mg

Review Committee.
32. DIACEREIN 50MG CAPSULES

Me-too Status
Available in EMA with

restictions.
Diora Capsule 50
mg by Getz
Remarks
On 19 March 2014, the Co-ordination Group for
Mutual Recognition and Decentralised Procedures
Human (CMDh) endorsed recommendations to
restrict the use of diacerein-containing medicines in
order to manage the risks of severe diarrhoea and
effects on the liver.
Due to the risks associated with severe diarrhoea,
diacerein is no longer recommended in patients aged
65 years and above. It is also advised that patients start
treatment on half the normal dose (i.e. 50 mg daily
instead of 100 mg) and should stop taking diacerein if
diarrhoea occurs.
In addition, diacerein-containing medicines must now
not be used in any patient with liver disease or a
history of liver disease, and doctors should be
monitoring their patients for early signs of liver
problems.
Doctors should also note that, based on available data,
the use of diacerein is to be limited to treating
196
symptoms of osteoarthritis affecting the hip or knee.

Treatment should only be started by doctors
experienced in treating osteoarthritis.
These recommendations are based on the review of the
benefits and risks of diacerein conducted by the
EMAs Pharmacovigilance and Risk Assessment
Committee (PRAC) and follow concerns raised by the
French medicines agency (ANSM) about diacereins
gastro-intestinal and liver effects. The CMDh
endorsed the PRACs final recommendations to
address these concerns and ensure that diacereins
benefits continue to outweigh its known risks.
As the CMDh position on diacerein was adopted by
majority vote, it was sent to the European Commission
which endorsed it and issued a final legally binding
decision valid throughout the European Union (EU)
on 4 September 2014.
(Ref: EMA)

product
for
regsitatrion
in
246th
meeting
of

discussed comments of stakeholders in 246th meeting
and decided that Review Committee will review these
comments for framing its final recommendation).
475. M/s.
Wellness
Pharmaceuticals
(Pvt)
Ltd, Plot No. 33 Sunder
Diarein 50mg
Referred to review committee for review of

formulation
Capsule
Each Capsule contains:Diacerein B.P .50mg
Anthraquinone derivative
Manufacturers
Specifications
(M-243)
197
476.
M/s Macter International

(Pvt.) Limited.
F-216, S.I.T.E., Karachi.
(M-246)
Mirin Capsule 50 mg

Review Committee.
Diacerein MS ..50 mg
Antirheumatics/ Pain
Management
Finished Product
Specifications are
Manufacturer
477.
478.
M/s Filix
Pharmaceuticals Rawat.
(M-238)
M/s. Novartana Pharma

Lahore
(M-239)
479.
M/s Hilton Pharma (Pvt).

Ltd. Karachi.
(M-241)
480.
M/s.Caraway
Pharmaceuticals,
Plant:Plot#12, Street#N3, National Industrial
Zone,(RCCI),
Rawat, Islamabad,
(M-241)
481.
M/s ARAF (Pvt) Ltd, 23Km, Raiwind Road,

Lahore.
(Formerly
M/s.
Remedy
Pharmaceutical (Pvt) Ltd,
23rd KM Raiwind Road,
Lahore.)
(M-242)
M/s Genix Pharma (Pvt)
Ltd., 44,45-B, Korangi
Creek Road, Karachi.
482.
Dynfix 50mg Capsules

Each capsule contains:Diacerein (INN)
50mg
(NSAID ANALGESIC)
Orthin 50mg Capsule
Each capule contains:Diacerein.50mg
Referred to the review committee.
Deferred for Submission of correct signed

application on form 5, raw materials and
finished product specifications and decision
of review committee.
Dicer Capsule
Diacerein (M.S) . 50mg
(for Treatment of
Osteoarthritis)
1. Caracerin
2. Tablets
3. Each tablet contains
Diacerien 50mg 4.
Anti-Inflammatory Agent

formulation.
1. Diacerem
2. Oral Capsule
3. Each capsule contains:Diacerein (M.S)50mg
4. (NSAIDs)

Review Committee.
1. OSTEO - G
Deferrd for review of formulation by

Review Committee.

formulation.
198
(M-242)
2. Capsules
3. Each capsule contains:
Diacerein ... 50mg
4. Anti Osteoarthritis.
33. ITOPRIDE 50MG TABLETS

Me-too Status
Remarks
Product literature of Ganaton 50 mg

(Abbot, Japan) shows that the drug is
available in Japan since 1983.
However, same cannot be verified form
PMDA Japan as official website
provides information from 2004-2014.
GANATON
By ABBOTT
Recommendation: Database of PMDA

Japan shows information of registered
drug in Japan from 2004 to 2014.
Therefore, same cannot be verified
from PMDA Japan as official website
483. M/s Searle IV Solutions (Pvt.)

Ltd, 1.5 km Manga Raiwind
Road, Manga Mandi, Lahore
(M-243)
484.
M/s. Metro Pharmaceuticals

Plot #14, Street No.SS-2,
National
Industrial
Zone,
Rawat, Islamabad
(M-243)
485.
M/s King Pharmaceuticals, 27Sunder Industrial Estate,

Raiwind Road, Lahore.
(M-244)
486.
M/s Noa Hemis

Pharmaceuticals, Plot No. 154,
Sector-23, Korangi Industrial
Area, Karachi-74900
(M-246-248)
Protide
Tablets
contains:Itopride HCl.50mg
(gastrokinetic)
(Manufacturers)
Metapride-50 Tablets
Tablet
Each film tablet contains:
Itopride Hydrohloride .
50mg
Gastroprokinetic
Manufacturer
Pride Tablet 50mg
Each tablet contains Itopride
as HCl 50mg.
Gastroprokinetic/ antiemetic
Manufacturer
Gasiton 50mg Tablet

by the review committee

by the Review Committee.

by review committee.

Itopride
Hydrochloride.50
199
mg
(Gastroprokinetic)
487.
488.
M/s WnsFeild Pharmaceuticals

Plot no. 122, Block B, Phase V,
Industrial Estate, Hattar
(M-246)
M/s. Med Asia Pharmaceuticals
Industries,
7-Nowshera
Industrial Estate, (Siz) Risalpur
(M-242)
Winprid Tablet
contains:Itopride HCl..50mg
Gastroprokinetic
1. Prokasia Tablets

2. Each film coated tablet

contains:-

Itopride HCl.50mg
3. Gastroprokinetic
489.
M/s The Searle Company

Limited,
1.Eziride

2.Tablet
32km, Multan road, Lahore.

(M-242)
3.Each tablet contains:

Itopride
Hydrochloride
50 mg
4.Gastrokinetic
34. ITOPRIDE 150MG SR TABLETS

Me-too Status
Remarks
Not available in reference agencies.
Ganaton (Abbott)
Available in India. Ganaton (India)

490. M/s Searle IV Solutions
(Pvt.) Ltd, 1.5 km Manga
Raiwind Road, Manga
Mandi, Lahore
(M-243)
Protide SR
Tablets
Each film coated sustained
release tablet contains:Itopride HCl.150mg
(Gastrokinetic)

by the review committee
200
491.
M/s
Welmark
Pharmaceuticals, Hattar.
(M-242)
1. WelPride
2. Tablets

3. Each tablet contains:Itopride

Hydrochloride....150mg
492.
M/s.
Medisave
Pharmaceuticals Plot No:
578-579, Sundar industrial
Estate, Lahore
(M-242)
493.
M/s The Searle Company

Limited,
1. Etiosave
2. Tablets
3. Each film coated sustained
release tablet contains:Itopride HCl150mg
1.Eziride XR
2.Tablet
32km, Multan road,

Lahore.



Itopride hydrochloride 150
mg
(M-242)
4.Gastrokinetic
494.
M/s
Saibins
Pharmaceuticals,
Plot
No.316 Industrial Triangle,
Kahuta Road, Islamabad
(M-242)
1.Ito SR 150mg Tablets

2. Tablet

by Review Committee
3. Each SR film coated Tablet

contains:
Itopride HCl .. 150mg
4. Gastrointestinal drugs
35. ITOPRIDE 150MG SR CAPSULES

Me-too Status
Remarks

agencies.
IPRIDE SR(WILSHIRE
LABORATORIES (PVT) LTD.)
201
495.
M/s Faas
Pharmaceuticals
(Pvt.) Limited F784/L S.I.T.E.
Karachi
(M-246)
Itometic Capsule
Itopride hydrochloride150mg
(as sustained release pellets)
(Gastoprokinetic / antiemetic)
(Source of Pellets:
M/s Titan Laboratories Private
Limited Plot No. E27/1, E27/2,
MIDC, Mahad Village Jite
District, Raigad, Maharashtra,
India)

alongwith the rectification of following
observations:
1. Fee for import of pellets, Legalized
Copy of Valid GMP certificate of
manufacturer of Pellets;
2. stability studies according to zone of
Pakistan of Pellets are required.
36. CITICOLINE 500MG TABLETS

Me-too Status
Remarks

SRAs
Cercolin (Schazoo)

(Available in Italy as per PPMA)
recommendation).
496. M/s Searle IV Solutions (Pvt.)

(M-243)
497.
M/s NovaMed
Pharmaceuticals Pvt. Ltd. 28Km, Ferozepur Road, Lahore
(M-244)
498.
M/s Focus & Rulz

Pharmaceuticals (Pvt.) Ltd,
Neurocare 500mg
Tablets
contains:Citicoline sodium eq. to
Citicoline.500mg
(Nootropics &Neurotonic)
1.Oxycholine
2.Tablet
Citicoline.500mg
4.Psychotherapeutic
Clarmak 500mg Tablets
Each tablet contains:-

review committee

review committee.
Referred
to the Review Committee
202
Islamabad
Citicoline 500mg
(Nootropics &
Neurotonics)
(M-237)
499.
M/s. Usawa Pharmaceuticals,

Risalpur
(M-238)
U-Cit Tablets
Referred to the review committee

contains:Citicoline Sodium
Citicoline.. 500
mg
(Nootropics & Neurotonic)
37. CITICOLINE 250MG/2ML INJECTION

Me-too Status
Remarks
Available in France. Citicoline

500mg/ 4 ml solution. Panpharma,
France.
Citolin (Global)
Available in France. Citicoline 500mg/ 4 ml

solution. Panpharma, France.
(Ref: ANSM, France)
(Ref: ANSM, France)

discussed comments of stakeholders in 246 th
recommendation).
500.
M/s Searle IV
Solutions (Pvt.) Ltd,
1.5 km Manga Raiwind
Road, Manga Mandi,
Lahore
(M-243)
1. Neurocare 250mg
2. Injection
3. Each 2ml contains:Citicoline sodium eq. to
Citicoline250mg
(Nootropics & Neurotonic)
Referred to review committee for review

of formulation
501.
M/s Medisure Labs

(Pvt.) Ltd, Karachi
(M-246)
Neurocoline 250mg/2ml Injection

Each 2ml contains:4. Citicoline
.250mg
Request of Neurocoline 250mg/2ml

Injection, Registration No.014084 will be
considered after recommendation of
Review Committee and decision of the
203
502.
M/s Medisure
Labs, Karachi contract
manufacturing by M/s
Indus
Transfer from toll to own facility

(Reg. No. 014084)
Neurocoline Injection
Each 2ml contains:-
Board on Citicoline.
Citicoline is under consideration by
review committee
Citicoline .250mg
Pharma,
Karachi
(M-240)
38. CITICOLINE 500MG/5ML ORAL LIQUID

Me-too Status
Remarks

SRAs
Cercolin (Schazoo)
Not available in reference SRAs

recommendation).
503.
504.
M/s NovaMed
Pharmaceuticals Pvt. Ltd.
28-Km, Ferozepur Road,
Lahore
(M-244)
M/s Focus & Rulz
Pharmaceuticals (Pvt.)
Ltd, Islamabad
(M-237)
1.Oxycholine
2.Oral Liquid
Citicoline.500mg
4.Psychotherapeutic
Clarmak 100mg Syrup
Each ml contains:Citicoline (as Sodium)
.100mg
( Nootropics & Neurotonics )

review committee.
204
Not approved by reference
drug agencies.
505.
506.
39. LEVOSULPIRIDE 25MG TABLETS

Me too status
Remarks
VESUPID of M/s Martin
Marketing authorization has been refused by the
Dow
national competent authority of Italy based on
SAPRIDE of M/s
unfavorable risk benefit balance and the same is
Standpharm
included in the EMA list of withdrawl medicines
SULPY of M/s Akhai
dated: 30-01-15
M/s Searle IV Solutions

Raiwind Road, Manga
Mandi, Lahore
(M-243)
Serlpride 25mg
Tablets
contains:Levosulpiride.25mg
(Benzamides antipsychotics)
Sulrog Tablet 25 mg

(RCCI), Rawat,
Islamabad.
Levosulpride 25 mg
(M-246)
Deferred for review of formulation by review

committee
Deferred for review of formualation by Review

Committee.
(Antidepressant/
Gastroprokinetic)
are Manufacturer
507.
M/s Amarant
158-D, Tore, Gadap Road,
Super High way Karachi
(M-241)
1.Sulpirant
2.Capsule
3.Each capsule contains:
Levosulpiride..25 mg
4.Psychotherapeutic Drugs
508.
M/s Max Pharmaceuticals,

Plot. No.705, Str.07,
Sector I-10/2, Islamabad.
(M-241)
509.
M/s
Miracle
Pharmaceuticals
(Pvt)
Limited, Plot No 8 Street
No.5 National Industrial
1.Aloft
2.Tablet
Levosulpiride25mg
4.Gastroprokinetic/
antidepressant
1.LEVOLIDE-25
2.Oral
3.Each
tablet
Levosulpiride 25mg

formulation

formulation.
Deferred for review of formulation by Review

Comiittee
contains
205
(M-242)
510.
4.Antidopamminergic
M/s.
Saim 1.Sipride Tablets 25mg
Pharmaceutical,
217,
Industrial
Triangle, S-Pride
Levoride
(M-242)
Deferred for reviw of formulation by Review

Committee
2.Tablets
contains:
Levosulpride ..50mg
4. Gastroprokinetic
drug agencies.
511.

Me too status
Remarks
VESUPID of M/s Martin
Not found in reference drug agencies. However
Dow
marketing authorization of 25 mg tablet has been
SAPRIDE of M/s
refused by the national competent authority of Italy
Standpharm
based on unfavorable risk benefit balance and he
SULPY of M/s Akhai
same is included in the EMA list of withdrawl
medicines dated: 30-01-15.
Sulrog Tablet 50 mg

(RCCI), Rawat, Islamabad.
Levosulpride 50 mg
(M-246)

Review Committee.
(Antidepressant/
Gastroprokinetic)
are Manufacturer.
512.
513.
M/s Amarant
158-D, Tore, Gadap Road,
Super High way Karachi
(M-241)
M/s Max Pharmaceuticals,
Plot. No.705, Str.07, Sector
I-10/2, Islamabad.
1.Sulpirant
2.Capsule
Levosulpiride..50 mg
4.Psychotherapeutic Drugs
1.Aloft
2.Tablet

formulation

formulation.
206
(M-241)
514.
M/s. Navegal Laboratories,

41/1-A2,
Phase-1
,
Industrial Estate, Hattar.
(M-242)
Levosulpiride50mg
4.Gastroprokinetic/
antidepressant
1.Dura 50mg Tablets
2. Each film
contains:-
coated
tablet

committee
Levosulpiride.50mg
3.Levosulpiride is a substituted
benzamide antipsychotic
515.
516.
1.LEVOLIDE-50
M/s
Miracle
Pharmaceuticals
(Pvt)
(M-242)
2.Oral
M/s. Saim Pharmaceutical,

217, Industrial Triangle,
1.Sipride Tablets 50mg
(M-242)
Levoride
3.Each
tablet
Levosulpiride 50mg

Review Comiittee
contains
4.Antidopamminergic
S-Pride
Deferred for reviw of formulation by Review

Committee
2.Tablets
contains:
Levosulpride ..50mg
4. Gastroprokinetic
drug agencies.

Me too status
Remarks
SULP of M/s Semos
LEVOPRIAD of M/s Pacific
marketing authorization of 25mg tablet has been
LINORIDE of Linear
Pharma
medicines dated: 30-01-15
207
517.
Sulrog Tablet 100 mg

(RCCI), Rawat,
Islamabad.
Levosulpride 100 mg
(M-246)
drug agencies.
518.
519.
(Antidepressant/
Gastroprokinetic)
are Manufacturer
42. LEVOSULPIRIDE 25MG CHEWABLE TABLETS

Me too status
Remarks
Not confirmed
marketing authorization of 25 mg tablet has been
M/s
Shrooq
Pharmaceuticals
(Pvt)
Ltd. 21 Km Ferozepur
Road Lahore.
(M-242)
M/s
Miracle
Pharmaceuticals
(Pvt)
(M-242)

Review Committee.
1. Pridon
2. ChewableTablets
3. Each Tablet contains:Levosulpiride25mg
4. (Antipshychotic drug)
1.Levotrol,Sulpid,Levosulpid
25mg Chewable tablet
Deferred for Completion of Form 5 and review

of formulation by Review Committee

Comiittee
2.Oral
3.Each
tablet
Levosulpiride 25mg
contains
4.Antidopamminergi
43. LEVOSULPIRIDE 50MG CHEWABLE TABLETS

Me too status
Remarks
Not approved by reference Not confirmed
drug agencies.
marketing authorization of 25mg tablet has been
208

520.
M/s Miracle Pharmaceuticals

(Pvt) Limited, Plot No 8 Street
No.5 National Industrial Zone,
Rawat, Islamabad
1.Levotrol,Sulpid,Levosulpi
d 50mg Chewable tablet
(M-242)
3.Each
tablet
contains
Levosulpiride 50mg

Review Comiittee
2.Oral
4.Antidopamminergi
Capsule dosage form is not
approved by reference drug
agencies. Only tablet dosge
form is approved.
521.
44. ETORICOXIB 60MG CAPSULES

Me too status
Remarks
Not found
Capsule dosage form is not approved by reference
drug agencies. Only tablet dosge form is approved.

Raiwind Road, Manga
Mandi, Lahore
(M-243)

Exoib 60mg
Capsule
Each capsule contains:Etoricoxib.60mg
(Antirheumatics)
Deferred for me
availability
too and international
45. ORLISTAT 120MG CAPSULES (IN POWDER FORMULATION)

Me too status
Remarks
Drug is not available in Not found
Xenical is presented as a conventional hard gelatin
powder form. However,
capsule (size 1) containing pellets with an active
capsule containing pellets is
substance concentration of 50%. The excipients
cellulose microcrystalline (as diluent and
agencies.
extrusion/spheronisation aid), sodium starch
glycollate (as desintegrant), sodium lauryl sulphate
(aswetting agent), povidone K30 (as binder and
stabiliser), and talc is added (for lubrication) to the
pellets before encapsulation.
209
522.

Raiwind Road, Manga
Mandi, Lahore
(M-243)
Obestat 120mg
Capsules
Each capsule contains:Orlistat.120mg
(Antiobesity)
(USP Spec.s)
Deferred for verification/ clarification of

formulation with originator
46. ORLISTAT 60MG CAPSULES (IN POWDER FORMULATION)

Me too status
Remarks
Drug is not available in Not found
Xenical is presented as a conventional hard gelatin
powder form. However,
capsule (size 1) containing pellets with an active
capsule containing pellets is
substance concentration of 50%. The excipients
cellulose microcrystalline (as diluent and
agencies.
extrusion/spheronisation aid), sodium starch
glycollate (as desintegrant), sodium lauryl sulphate
(aswetting agent), povidone K30 (as binder and
stabiliser), and talc is added (for lubrication) to the
pellets before encapsulation.
Drug is approved in France.
(Ipsen Pharma).
(Ref: ANSM, France)
523.
524.
47. DIOCTAHEDRAL SMECTITE 3.00GM SACHET

Me too status
Remarks
SMECTA of M/s Atco
Product is approved by the French drug agency
DIOSECTA of M/s
(Ipsen Pharma).
Woodwards
(Ref: ANSM, France)
SMECDRAL of M/s
Warafana

Raiwind Road, Manga
Mandi, Lahore
(M-243)
M/s. Hamaz
11-KM Lutafabad Road
Multan.
Additional Section:
Sachet section (non
antibiotics)
Lecta
Powder Sachet
Each sachet of powder contains:Dioctahedral smectite.3.00gm
(Absorbant antidiarrhoeals)
D-Mecta 3g sachet
Sachet
Each sachet contains:Dioctahedral smectite.3g
Anti-diarrheal

committee

committee
210
525.
Vide letter No. F. 6-1/2013

Lic (M-232)
(M-244)
M/s Faas Pharmaceuticals
(Pvt.) Limited F-784/L
S.I.T.E. Karachi
(M-246)
Drug is not approved by
reference drug agencies in
dry suspension. However,
capsule form is available in
MHRA. (Erdotin 300mg
capsule of M/s Galen
Pharma, UK.)
526.

Review Committee.
48. ERDOSTEINE 175 MG DRY SUSPENSION

Me too status
Remarks
DOSTIN of M/s Brookes,
Not found in reference drug agencies.
Karachi.
M/s Searle IV Solutions (Pvt.)

(M-243)
Available in EMA with
limited indications i.e. acute
pain
and
pimary
dysmeanorrhoea.
Neomecta Sachet
Each Sachet contains:Dioctahedral Smectite3000mg
(Anti-diarrhioeals)
Esteine
Dry Suspension
Each 5ml (when reconstituted)
contains:Erdosteine.175mg
(Mucolytic)
Deferred for confirmation of me too

status and international availability
49. NIMESULIDE 100MG TABLETS

Me too status
Remarks
NIMEROL of M/s
Having considered the overall submitted data provided by
Brayon
the MAHs in writing and in the oral explanation, the
NEMSIS of M/s
CHMP (Committee for Medicianal Products for Human
Genome
Use) concluded:
NIMS of M/s SAMI
that evidence of the clinically efficacy of nimesulidecontaining products for systemic use in the indications for
short-term treatment has been shown. No unequivocal
and clinically meaningful
advantage over other NSAIDs has been demonstrated
and, therefore the Committee considered the efficacy of
nimesulide to be similar to other NSAIDs available.
that nimesulide overall gastrointestinal toxicity is
comparable to other NSAIDs but that nimesulide
211
is associated with an increased risk for hepatotoxicity. The

combined safety profile in terms of
hepatotoxicity and gastro intestinal toxicity for nimesulide
is shown as worse than some other
alternative NSAIDs such as diclofenac and naproxen.
Furthermore, the limitations of the current available data
lead to uncertainties on hepatotoxicity, and concerns
remain especially with prolonged use of nimesulide.
Considering the maximum duration of 15 days of
treatment to minimise the risk for hepatotoxicity
and aiming a further minimisation of the risks associated
with nimesulide, the Committee considered that
nimesulide use should be restricted to acute conditions
only i.e. treatment of acute pain and primary
dysmenorrhoea.
That in light of the above, considered that there is a
risk of chronic use of nimesulide in symptomatic
treatment of painful osteoarthritis and concludes that the
risk-benefit balance of nimesulide-containing medicinal
products for systemic use is no longer favourable in this
indication.
(Ref: EMA Asessment Report)
527.
M/s Venus Pharma 23

KM Multan Road
Lahore.
(M-243)
drug agencies in capsule
dosage form.
528.
NIMSOL-100 TABLET
Each
tablet
contains
Nimesulide100mg
NSAID
Deferred for review of formulation by the Review

Committee.
50. PAROXETINE AS HCL 20MG CAPSULES

Me too status
Remarks
Not me too (firm applied on
Not found in reference drug agencies. FDA
Form-5D)
approved Brisdelle capsules which contains 9.69
mg paroxetine mesylate equivalent to 7.5 mg
paroxetine base.
M/s
Amarant
Pharmaceuticals
(Pvt)
Ltd., 158D Tore, Gadap
Road, Super Highway,
Karachi
(M-242 & 243)
GEROX CAPSULE 20 MG

availability
Capsule
Paroxetine as Hcl . 20mg
212
Psychotherapeutic drugs.
Manufacturers specification.
51. ROXITHROMYCIN 50MG/5ML DRY SUSPENSION

Me too status
Remarks
Not approved by reference Not confirmed
Dry powder for suspension of Roxithromycin is not
drug agencies in dry
approved by the reference drug agencies. However,
suspension form.
Therapeutics Goods Administration of Australia
has approved Rulide D, 50mg tablets for
suspension.
Rulide D 50mg tablets are administered to children
weighing less than 40kg as an aqueous suspension
that is made by adding either a half, one or two
tablets to a spoonful of water. After waiting for 30
to 40 seconds for the tablet(s) to disintegrate into
fine granules, the suspension is given to the child.
529.
M/s. Jaskan Pharmaceuticals

(Pvt) Ltd, Plot No. 50, Sundar
(M-243)
Roxikan 50mg
Dry Suspension
Each 5ml contains:Roxithromycin..50mg
(Macrolide antibiotic)
Deferred for confirmation of me too s tatus
52. CALCIUM LACTATE GLUCONATE 1000MG SACHET

Me too status
Remarks
Not approved by reference Not found
drug agencies.
530.
M/s
Jaskan
Pharmaceutic
als
(Pvt)
Limited, 50
Sunder
Industrial
Estate
Raiwind
Road, Lahore
(Sachet
Calkan 1000 Sachet

Sachet
Each sachet contains
Calcium lactate gluconate1000mg

availability and me too status
213
section)
(M-243)
53.
OMEPRAZOLE 20MG + SODIUM BICARBONATE 1680MG SACHET
ZEGERID Sachet approved
by FDA
531.
Me too status
RULLING PLUS of M/s
High Q
OMENATE of M/s Panecea
M/s. Jaskan
Plot No. 50, Sundar
(M-243)
Remarks
Omeprazole is acid labile and thus rapidly degraded
by gastric acid. ZEGERID Capsules and Powder
for Oral Suspension are immediate-release
formulations that contain sodium bicarbonate
which raises the gastric pH and thus protects
omeprazole from acid degradation.
(Ref: FDA)
Jasom 20mg Sachet

Sachet
Each sachet contains
Omeprazole 20mg/ Sodium
bicarbonate 1680mg
Proton Pump Inhibitor

committee
Manufacturer
532.
M/s Nabiqasim Industries

Pvt Ltd. 17/24, Korangi
industrial Area, Karachi.
(M-244)
533.
M/s
Sigma
Pharma
International Pvt. Limited
E-50, N.W.I.Z., Port Qasim
Karachi
(M-246)
54.
1.Loprot Insta 2.Oral Suspension

3.Each sachet contains:
Omeprazole ..20 mg
Sodium Bicarbonate (as
Buffer)..1680 mg

committee
Profile 20mg Sachet
Deferred till review of formulation by Review

Committee.
Each Sachet contains:Omeprazole 20mg

Sodium Bicarbonate 1680mg
(Proton pump inhibitor/antacid)
OMEPRAZOLE 40MG + SODIUM BICARBONATE 1680MG SACHET
ZEGERID Sachet approved
by FDA
Me too status
OMEGA RAPID of
Ferozsons
OMEZONATE of M/s Global
Remarks
214

omeprazole from acid degradation.
(Ref: FDA)
534.
535.
536.
M/s. Jaskan
Pharmaceutic
als (Pvt) Ltd,
Plot No. 50,
Sundar
Industrial
Estate,
Lahore.
(M-243)
Jasom 40mg Sachet

Sachet
Each sachet contains Omeprazole 40mg/
Sodium bicarbonate 1680mg
Proton Pump Inhibitor
M/s
Nabiqasim
Industries Pvt
Ltd. 17/24,
Korangi
industrial
Area,
Karachi.
(M-244)
M/s
Sigma
Pharma
International
Pvt. Limited
E-50,
N.W.I.Z., Port
Qasim
Karachi
(M-246)
1.Loprot Insta 2.Oral Suspension 40mg

3.Each sachet contains:
Omeprazole ..40 mg
Sodium Bicarbonate (as Buffer)..1680 mg
4.Ant-ulcerant

committee.
Profile 40mg Sachet

Review Committee.
55.
Manufacturer
Each Sachet contains:Omeprazole 40mg

Sodium Bicarbonate 1680mg
(Proton pump inhibitor/antacid)
OMEPRAZOLE 20MG + SODIUM BICARBONATE 600MG + MAGNESIUM HYDROXIDE

700MG CHEWABLE TABLET
agencies. Discontinued by
USFDA.
537.

committee
Me too status
OMEGA RAPID of
Ferozsons

(Pvt.) Ltd, Karachi -75700.
Remarks
Not available in reference agencies. Discontinued
by USFDA.
Mazole Tablets
Each Chewable tablet contains:

formulation.
215
(M-241)
56.
OMEPRAZOLE 40MG + SODIUM BICARBONATE 600MG +MAGNESIUM HYDROXIDE

700MG CHEWABLE TABLET
agencies. Discontinued by
USFDA.
538.
Omeprazole (B.P)... 20mg

Sodium Bicarbonate(B.P)
. .600mg mg (7 mEq)
(equivalent to 164 mg of Na+)
Magnesium Hydroxide (B.P)
700mg (24mEq) (equivalent to
290 mg of Mg++).
(Proton Pump Inhibitor, Antacid)
Me too status
OMEGA RAPID of
Ferozsons

(Pvt.) Ltd, Karachi
-75700.
(M-241)
Remarks
Not available in reference agencies. Discontinued
by USFDA.
Mazole Tablet
Each Chewable tablet contains:
Omeprazole
(B.P)40mg Sodium Bicarbonate
(B.P)..600mg mg (7 mEq)
(equivalent to 164 mg of Na+)
Magnesium Hydroxide (B.P)
700mg (24mEq) (equivalent to 292
mg of Mg++).
(Proton Pump Inhibitor, Antacid)

formulation.
57. OMEPRAZOLE 20MG + SODIUM BICARBONATE 1100MG SACHET

Me too status
Remarks
Not approved by reference RISEK INSTA of M/s Getz
FDA approved formulation ZEGERID is supplied
drug agencies in this
as immediate-release capsules and unit-dose
strength.
packets as powder for oral suspension. Each
capsule contains either 40 mg or 20 mg of
omeprazole and 1100 mg of sodium bicarbonate
with the following excipients: croscarmellose
sodium and sodium stearyl fumarate. Packets of
powder for oral suspension contain either 40 mg or
20 mg of omeprazole and 1680 mgof sodium
bicarbonate with the following excipients: xylitol,
sucrose, sucralose, xanthan gum, and flavorings.
216
559.
M/s. Hamaz
Pharmaceuticals (Pvt)
Ltd, 11-KM Lutafabad
Road Multan.
Additional Section:
Sachet section (non
antibiotics)
Vide letter No. F. 61/2013 Lic (M-232)
(M-244)
58.
561.

committee.
OMEPRAZOLE 20MG + SODIUM BICARBONATE 1100MG CAPSULES
ZEGERID capsule approved
by FDA
560.
Hamazol Plus sachet

Sachet
Each sachet contains:Omeprazole . 20mg
Sodium bicarbonate
. 1100mg
Anti-ulcerant
M/s Helix Pharma (Pvt)

Ltd., Hakimsons House,
A/ 56, S.I.T.E., Karachi
(M-246)
M/s PPPP, Karachi

(M-238)
Me too status
BIOS of M/s Werrick
PRENAT of M/s SJ&G
Remarks
omeprazole from acid degradation. FDA approved
formulation ZEGERID is supplied as immediaterelease capsules. Each capsule contains either 40
mg or 20 mg of omeprazole and 1100 mg of sodium
bicarbonate with the following excipients:
croscarmellose sodium and sodium stearyl
fumarate
(Ref: US FDA)
Primavera/ Omni Plus/ Ristor/

Omnita Omitag/ OSB Capsule
Omeprazole..20mg
Sodium Bicarbonate .1100mg
(Strength has been corrected as
1100 mg which was typed as
110mg in the agenda copy)
Proton Pump Inhibitor & Antacid
Xobib Capsule 20mg

Review Committee.
Deferred for review of formulation as

decided by Registration Board
Omeprazole ..20mg
Sodium Bicarbonate
.1100mg
217
59.
OMEPRAZOLE 40MG + SODIUM BICARBONATE 1100MG CAPSULES
ZEGERID capsule approved
by FDA
562.
Me too status
BIOS of M/s Werrick
PRENAT of M/s SJ&G
M/s Nabiqasim Industries

Pvt Ltd. 17/24, Korangi
industrial Area, Karachi.
(M-244)
60.
Remarks
omeprazole from acid degradation. FDA approved
formulation ZEGERID is supplied as immediaterelease capsules. Each capsule contains either 40
mg or 20 mg of omeprazole and 1100 mg of sodium
bicarbonate with the following excipients:
croscarmellose sodium and sodium stearyl
fumarate
(Ref: US FDA)
1.Loprot plus
2.Capsule
Omeprazole .40 mg
Sodium Bicarbonate..
1100 mg
4.Ani-ulcerant

committee
ACLIDINUM BROMIDE 400 MCG EQ TO ACLIDINUM 343 MCG CAPSULES
Not approved on reference
drug agencies. However, it is
available as metered dose
inhaler inUS FDA.
Me too status
Not me too
Remarks
Not found in reference drug agencies, however the
FDA approved aclidinium with following
description:
TUDORZA/PRESSAIR(aclidinium
bromide
inhalation powder) 400 mcg is suppliein a sealed
labeled aluminum pouch and is available in 60
metered doses (NDC0456-0800-60) and 30 metered
doses (NDC 0456-0800-31). The active ingredient is
administered using a multi-dose dry powder
inhaler, PRESSAIRwhich delivers 60 doses or 30
doses of aclidinium bromide powder fororal
inhalation. The PRESSAIR inhaler is a white and
green colored device and iscomprised of an
assembled plastic dosing mechanism with a dose
indicator, a drugproduct storage unit containing
the drug-product formulation, and a mouthpiece
covered by a green protective cap. The inhaler
should be discarded when themarking 0 with a
218
red background shows in the middle of the dose

indicator orwhen the device locks out, whichever
comes first.
563.
M/s Hiranis
Pharmaceutical Pvt. Ltd.
Plot.No. E-145-149,
North western Industrial
Zone, Port Qasim,
Karachi.
(M-243)
Aclidum Capsule
Capsule
Each capsule contains Aclidinum
Bromide 400 mcg eq to Aclidinum
343 mcg
(Anticholinergic)
Deferred for PSI & international availability

status in capsule dosage form.
Manufacturer
219
61.
drug agencies. However,
enteric coated tablet dosage
form is approved.
564.
PANTOPRAZOLE SODIUM 40 MG CAPSULES
Me too status
PANTOSWAN of M/s Swan
PANTOZOL of M/s Valor
HOZE of M/s Max
M/s Jaskan
Pharmaceuticals (Pvt.)
Limited.
Plot No. 50, Sundar
(M-243)
Remarks
Gastroresistant tablets are approved in reference
drug agencies.
Pantox Capsule
Deferred for confirmation of SRA approved

dosage form.
Capsule
Each capsule contains pellets of
Pantoprazole Sodium 40 mg
565.
M/s. Simz Pharmaceuticals

(Pvt) Ltd, 574-575 Sundar
Industrial Estate, Raiwind
Road Lahore.
(M-244)
566.
M/s Linear Pharma, Rawat

Islamabad.
(M-246)
are Manufacturer.
Pantone 40mg
Capsule
Each capsule contains:Pantoprazole sodium enteric
coated pellets equivalent to
Pantoprazole40mg
(Antiulcer)
Source of pellets: M/s Vision
Pharmaceuticals, Plot No. 224, I10/3, Islamabad
PENTO Capsule 40mg
Pantoprazole sodium 22.5 %
pellets
equivalent
to
Pantoprazole..40mg

availability.
Deferred for review of formulation.
PPI
Manufacturer
Source: Vision Pharmaceuticals
Islamabad.
62. PANTAPRAZOLE AS SODIUM SESQUIHYDRATE40MG + ITOPRIDE HCL

SUSTAINED RELEASE PELLETS150MG CAPSULES
Me too status
Remarks
220

drug agencies
567.
Not me too
M/s Hilton Pharma,

Karachi
(M-241)
Zopent-ITO 40/150 Capsules

Each capsule conatins:Pantaprazole as Sodium
Sesquihydrate40mg
Itopride HCl sustained release
pellets150mg
(For GERD)
63.
HIDRASEC INFANTS 10
mg, Granules for oral
suspension
(MHRA
Approved)
568.
Hidrasec 10mg Sachet

Each sachet contains:Racecadotril10mg
(Anti-Diarrheal).
Deferred for confirmation of approval status

in FDA, EMA, TGA and Japan.
RACECADOTRIL 30 MG SACHETS
Me too status
Not me too
M/s. Abbott Laboratories

(Pakistan) Limited,
Karachi. /
M/s. Laboratoires
SOPHARTEX 21 Rue du
Pressoir Vernouillet,
France.
(M-243, & 248)
Remarks
Formulation is MHRA approved.
Import Application
64.
569.

formulation
RACECADOTRIL 10MG SACHET
Me too status
Not me too

(Pakistan) Limited,
Karachi. /
M/s. Laboratoires
SOPHARTEX 21 Rue du
France.
(M-243, & 248)
HIDRASEC CHILDREN 30
mg, Granules for oral
suspension
(MHRA
Approved)
Hidrasec 30mg Sachet

Each sachet contains:Racecadotril.30mg
(Anti-Diarrheal).
Import Application
Remarks
Formulation is MHRA approved.
Deferred for confirmation of approval

status in FDA, EMA, TGA and Japan.
221
65.
Not
approved by the
570.
Me too status
Not me too

(Pakistan) Limited,
Karachi. /
M/s. Laboratoires
SOPHARTEX 21 Rue du
France.
(M-243, & 248)
Hidrasec 100mg Capsules

Each capsule contains:Racecadotril.100mg
(Anti-Diarrheal).
571.
Antisec Sachet
Each Sachet contains:Racecadotril (B.P)15mg
(Anti-Diarrheal)
67.
Not
approved by the
572.
Remarks
10mg and 30mg sachets are approved by MHRA.
Deferred for confirmation of approval in

reference Stringent Regulatory Agencies &
me too status.
UDENAFIL 100MG TABLETS
Me too status
Not me too
M/s. Matrix Pharma (Pvt)

Ltd., Karachi. /
M/s. Dong-A Pharm Co Ltd
Yongdu-Dong,
Dongdaemun-Ku, Seoul
Korea.
(M-243)
Deferred for confirmation of approval status in

FDA, EMA, TGA and Japan.
Me too status
Not me too
M/s Faas Pharmaceuticals

S.I.T.E. Karachi
(M-246)
Remarks
10mg and 30mg sachets are approved by MHRA.
Import Application
66.
Not
approved by the
Zydena 100mg Tablet

Each tablet contains: Udenafil.100mg
Remarks
Deferred for safety and clinical data of the

drug along with complete clinical trial data.
PDE5-Inhibitor
(Erectile Dysfunction)
222
Import application
68.
Not
approved by the
573.
UDENAFIL 200MG TABLETS
Me too status
Not me too
M/s. Matrix Pharma (Pvt)

Ltd., Karachi. /
M/s. Dong-A Pharm Co Ltd
Yongdu-Dong, DongdaemunKu, Seoul Korea.
(M-243)
Remarks
Zydena 200mg Tablet

Each tablet contains: Udenafil.200mg
Deferred for safety and clinical data of the

drug along with complete clinical trial data.
(Erectile Dysfunction)
69. Cholecalciferol 1000iu /5ml Syrup

Not
approved by the
574.
Me too status
Not confirmed
M/s Zanctok
Pharmaceuticals
Laboratories, Plot No.F-5-15
SITE, Area, Hyderabad
(M-244)
Remarks
1.Vital-D
2.Syrup
Cholecalciferol...1
000iu
4.vitamin D

availability.
70. Cholecalciferol 60, 000 iu Sachet
Not
approved by the
575.
Me too status
Not confirmed
M/s Faas Pharmaceuticals Ostrolife Sachet

Each Sachet contains:S.I.T.E. Karachi
Cholecalciferol (USP)
Remarks
Deferred for confirmation of approval in

reference Stringent Regulatory Agencies & me
223
(M-246)
60,000IU
(Vitamin)
too status.
71. Cholecalciferol 15mg Injection

Not
approved by the
Me too status
Not confirmed
576. M/s.Ray Pharma (Pvt) Ltd. S58, S..I.T.E Karachi.

(M-242)
Remarks
1.Invital-D Injection
600,000I.U
Deferred for review of formulation as

dose is on higher side
2.Injection (IM)
3. Each ml contains:
Cholecalciferol .. 15mg
4. Vitamin D analogue
72. Cholecalciferol 5mg Tablets
Not
approved by the
Me too status
Not confirmed
Remarks
577. M/s.
Wnsfeild 1. Delta D-3 Tablets
Pharmaceuticals, Plot No.
122, Block A, Phase V, 2. Each tablet contains:Industrial Estate, Hattar.
3. Cholecalciferol 200000 IU
equivalent to Cholecalciferol
(M-242)
5mg

Review Committee
4. Vitamin, minerals, tonics and

other substances.
578. M/s. Winbrain Research
Laboratories, Plot No.
69/1, Block B, Phase I-II,
Industrial Estate, Hattar.
1. Tonic-D Tablets
2. Each tablet contains:-

Review Committee.
3.Cholecalciferol.5mg (200000
224
(M-242)
IU)
4.. Cholecalciferol is an active
metabolite of Vitamin D, which
performs important functions in
regulation of the calcium balance
and the bone metabolism.
73. Cholecalciferol 2000 IU Tablets
Not
approved by the
Me too status
Not confirmed
579. M/s. Saaaf Pharmaceutical

Industries, 15 Nowshera
Industrial Estate, Risalpur.
Remarks
1. Gan-D Tablets

Committee
2. Each tablet contains:Cholecalciferol..

..2000IU
(M-242)
3.Vitamin D3 Analogue
74. TAMSULOSIN HYDROCHLORIDE 0.4MG + DUTASTERIDE 0.5 MG TABLETS

Me-too Status
Remarks
Not available in tablet form
Me-too status not

confirmed
Tablet form of the drug is not available
580.
M/s Allmed Pvt. Ltd.

(Formerly, EverGreen
Pharmaceuticals, Pvt. Ltd.
Plot.No.590, Sundar Industrial
Estate Lahore.
581.
Getz Pharma (Pvt) Limited,

29/30/27, Korangi Industrial Area,
1.Uriflow D
2.Tablet
Tamsulosin
hydrochloride0.4mg
Dutasteride.0.5
mg
4.Intracellular enzyme
1. Tamsolin D Tablets
Deferred
for
review
of
formulation by review committee
2.
1) The formulation / dosage form
Film
coated
tablets
Deferred for the following:
225
Karachi
(containing Tamsulosin Hcl

as enteric coated part while
Dutasteride compressed over
enteric coated part as
immediate release).
is already under review.
2) Confirmation of manufacturing
facility.

contains:
Tamsulosin
Hcl
. 0.4mg
USP
3) Replacement of methylene
chloride.
Dutasteride . 0.5mg
4.
adrenoreceptor
antagonist + 5 reductase
inhibitor.
75. DUTASTERIDE 0.5MG PELLETS + TAMSULOSIN 0.4MG PELLETS CAPSULES

(FORMULATION DIFFERENT FROM ORIGINATOR)
Combodart 0.5 mg / 0.4 mg
hard capsules of M/s GSK,
UK
582.
M/s. CCL Pharma Lahore
Me-too Status
Remarks
DUODART of M/s GSK,

Karachi
Internationally formulation is available in

the form of: hard capsule contains
tamsulosin hydrochloride modified release
pellets and one dutasteride soft gelatin
capsule.
BPH Capsules
Registration Board deferred the case for

evaluation by the review committee.
Dutasteride.0.5mg
Tamsulosin.0.4mg
583.
M/s. English
Dutride-T Capsules
Pharmacutical
s Industries,
Dutasteride .0.5mg
DRB deferred the case for evaluation by

review committee.
226
Lahore
Tamsulosin
Hydrochloride.0.4mg

agencies.
Me too status
NOVIDAT of M/s Sami
Remarks
Description:
Ciprofloxacin Oral Suspension is available in 5%
(5 g ciprofloxacin in 100 mL) and 10% (10 g
ciprofloxacin in 100 mL) strengths. Ciprofloxacin
Oral Suspension is a white to slightly yellowish
suspension with strawberry flavor which may
contain yellow-orange droplets.
povidone,
of sucrose.
580.
M/s Getz Pharma Karachi
Orpic
500mg/5ml
Suspension
Each 5ml contains:Ciprofloxacin ..500mg
(Anti biotics)
60ml; Rs.400.00
120ml; Rs.800.00
11/08/2010
Dy. No. 1559
Form 5-D
Rs. 15000/Rs.5,000/13-5-2013
Deferred for clarification whether firm

will use granules or powder and fee
227
Deferred Cases
Evaluator III
Case No: 1
Following Cases of pregabalin were deferred by board in its previous meetings. Firms have now rectified
the observations / shortcomings as follows:
S/N
Name and
address of
manufactu
rer
/
Applicant
Brand Name
(Proprietary
name + Dosage
Form
+
Strength)
Composition
Pharmacologic
al Group
Finished
product
Specification
Type of Form
Decision of 248th
Initial
date, Meeting
diary
Fee including
differential fee
Demanded
Price / Pack
size
Remarks
587.
M/s
Mediate
Karachi.
Medirica 50mg
Capsule
Form-5
Fee challans
Rs.8000/require
verification
The firm has

rectified the
shortcoming
s
except
evidence of
section
approval
from
Licensing.
Each Capsule
contains:
Pregablin ....50
mg
(Alpha 2 Delta
Ligand)
Manufacturers
specifications
Rs.12,000/27-10-2014
Rs.250/14s
Internation
al status in
stringent
drug
regulatory
agencies /
authorities
Me-too
status
GMP status
as depicted
in
latest
inspection
report
(with date)
by
the
Evaluator
Deferred. Final LYRICA
notice of 30 days Capsules
for rectification 50mg
of
below US FDA
mentioned
shortcomings/
GABICA
observations:
Capsules
1) Rs. 8,000/- fee 50mg
challan was not Getz
available in the
registration
Inspection
application, firm report dated
was
informed 24-11-2014.
accordingly.
However,
the
copies of challans
need verification
from
accounts
dept, drap.
2)
Indications,
dosage
and
administration
228
588.
-do-
Medirica 100mg
Capsule
Each Capsule
contains:
Pregablin ....100
mg
(Alpha 2 Delta
Ligand)
Manufacturers
specifications
Form-5
Fee challans
Rs.8000/require
verification
Rs.12,000/27-10-2014
Rs.450/14s
information to be
submitted
as
approved
by
reference
drug
agencies
e.g.,
FDA,
TGA,
MHLW,
EMA
and
Health
Canada. Firm has
included off label
indications and
comparative
dosage
of
Pregabalin with
Gabapentin.
3) Evidence of
approval
of
section
/
manufacturing
facility.
4) FID in his
report dated 2411-2014 advised
firm to purchase
Auto HPLC due
to large number
of products and
to purchase one
more
stability
chamber. As per
equipment
list,
only one stability
chamber
is
available
with
firm.
Deferred. Final
notice of 30 days
for rectification
of
below
mentioned
shortcomings/
observations:
1) Rs. 8,000/- fee
challan was not
available in the
registration
application, firm
was
informed
accordingly.
However,
the
copies of challans
LYRICA
Capsules
100mg
US FDA
GABICA
Capsules
100mg
Getz
The firm has

rectified the
shortcoming
s
except
evidence of
section
approval
from
Licensing.
229
589.
-do-
Medirica 150mg
Capsule
Each Capsule
contains:
Pregablin ....150
mg
(Alpha 2 Delta
Ligand)
Form-5
Fee challans
Rs.8000/require
verification
Rs.12,000/27-10-2014
Rs.600/14s
need verification
from
accounts
dept, drap.
2)
Indications,
dosage
and
administration
information to be
submitted
as
approved
by
reference
drug
agencies
e.g.,
FDA,
TGA,
MHLW,
EMA
and
Health
Canada. Firm has
included off label
indications and
comparative
dosage
of
Pregabalin with
Gabapentin.
3) Evidence of
approval
of
section
/
manufacturing
facility.
4) FID in his
firm to purchase
Auto HPLC due
to large number
of products and
to purchase one
more
stability
chamber. As per
equipment
list,
only one stability
chamber
is
available
with
firm.
Deferred. Final
notice of 30 days
for rectification
of
below
mentioned
shortcomings/
observations:
1) Rs. 8,000/- fee
challan was not
available in the
LYRICA
Capsules
150mg
US FDA
GABICA
Capsules
150mg
Getz
The firm has

rectified the
shortcoming
s
except
evidence of
section
approval
from
Licensing.
230
Manufacturers
specifications
registration
application, firm
was
informed
accordingly.
However,
the
copies of challans
need verification
from
accounts
dept, drap.
2)
Indications,
dosage
and
administration
information to be
submitted
as
approved
by
reference
drug
agencies
e.g.,
FDA,
TGA,
MHLW,
EMA
and
Health
Canada. Firm has
included off label
indications and
comparative
dosage
of
Pregabalin with
Gabapentin.
3) Evidence of
approval
of
section
/
manufacturing
facility.
4) FID in his
firm to purchase
Auto HPLC due
to large number
of products and
to purchase one
more
stability
chamber. As per
equipment
list,
only one stability
chamber
is
available
with
firm.
231
590.
-do-
Medirica 75mg
Capsule
Each Capsule
contains:
Pregablin ....75
mg
(Alpha 2 Delta
Ligand)
Manufacturers
specifications
Form-5
Fee challans
Rs.8000/require
verification
Rs.12,000/27-10-2014
Rs.350/14s
Deferred. Final
notice of 30 days
for rectification
of
below
mentioned
shortcomings/
observations:
1) Rs. 8,000/- fee
challan was not
available in the
registration
application, firm
was
informed
accordingly.
However,
the
copies of challans
need verification
from
accounts
dept, drap.
2)
Indications,
dosage
and
administration
information to be
submitted
as
approved
by
reference
drug
agencies
e.g.,
FDA,
TGA,
MHLW,
EMA
and
Health
Canada. Firm has
included off label
indications and
comparative
dosage
of
Pregabalin with
Gabapentin.
3) Evidence of
approval
of
section
/
manufacturing
facility.
4) FID in his
firm to purchase
Auto HPLC due
to large number
of products and
to purchase one
more
stability
LYRICA
Capsules
75mg
US FDA
GABICA
Capsules
75mg
Getz
The firm has

rectified the
shortcoming
s
except
evidence of
section
approval
from
Licensing.
232
Sr. No.
Name
and
address
of
Manufacturer /
Applicant
Brand Name
(Proprietary
name + Dosage
form + Strength)
Composition
Pharmacological
Group
chamber. As per
equipment
list,
only one stability
chamber
is
available
with
firm.
Type of Form
International
status
in
Initial date, stringent
diary.
regulatory
agencies
Fee
including
differential fee
Me-too status
Demanded
Price / Pack size
Finished product
specification
591.
592.
M/s Rotexmedica
Pakistan
(Pvt)
Ltd., Plot No. 206207,
Industrial
Triangle, Kahuta
Road, Islamabad.
M/s Rotexmedica
Pakistan
(Pvt)
Industrial
Triangle, Kahuta
Road, Islamabad.
Novatron Capsule
75mg
Each Capsule
Contains:
Pregabalin
75mg
Form 5
Rs.8000/20-02-2010
Dy. No. 205 R&I
(Antiepileptic)
Rs.12000/14-03-2014
Dy. No. 900 R&I
Manufacturers
specifications
Price as per PRC

14s
Novatron Capsule
150mg
Each Capsule
Contains:
Pregabalin
Form 5
Rs.8000/20-02-2010
Dy. No. 206 R&I
Remarks /
Observations
GMP status as
depicted
in
inspection report
(dated)
LYRICA
Capsules 75mg
US FDA
GABICA
Capsules 75mg
Getz
Inspection of the
firm
regarding
renewal of DML
was conducted on
09-01-15 by the
panel
of
inspectors
and
uniamously
recommends the
renewal of DML.
Capsule section
reported
in
renewal
inspection
of
DML dated 0901-15
LYRICA
Capsules 150mg
US FDA
GABICA
Capsules 150mg
233
150mg
(Antiepileptic)
593.
M/s Rotexmedica
Pakistan
(Pvt)
Industrial
Triangle, Kahuta
Road, Islamabad.
Manufacturers
specifications
Novatron Capsule
300mg
Each Capsule
Contains:
Pregabalin
300mg
(Antiepileptic)
594.
M/s
Dyson
Research
Laboratories (Pvt)
Ltd. 28th Km,
Ferozepur Road,
Lahore.
Manufacturers
specifications
Pregab 50mg
Capsules
Each Capsule
contains:
Pregabalin
.. 50mg
Anti-Epileptic.
Manufacturers
specifications
595.
-do-.
Pregab 100mg
Capsules
Each Capsule
Rs.12000/14-03-2014
Dy. No. 902 R&I
Price as per PRC
14s
Form 5
Rs.8000/20-02-2010
Dy. No. 209 R&I
Rs.12000/14-03-2014
Dy. No. 901 R&I
Price as per PRC
14s
Form 5
Rs.8,000/20-10-2008.
Rs.12,000/Dy.No.427-R&I
dated 05-12-2014.
Getz
LYRICA
Capsules 300mg
US FDA
GABICA
Capsules 300mg
Getz
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50,
75, 100 and
150mg)
Pack size 14s Hilton
M.R.P. Rs. As Per
Inspection of the
SRO
firm was carried
out on 26-09-14
by the area FID
and nothing was
reported
in
violation
of
GMP.
Form 5
Rs.8,000/20-10-2008.
Capsule section
reported
in
renewal
inspection
of
DML dated 2602-10
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
234
contains:
Pregabalin
...100mg
Anti-Epileptic.
Manufacturers
specifications
596.
-do-.
Pregab 150mg
Capsules
Each Capsule
contains:
Pregabalin
...150mg
Rs.12,000/Dy.No.427-R&I
dated 05-12-2014.
US FDA
Form 5
LYRICA
Capsules 150mg
US FDA
ZEEGAP
Capsules (25, 50,
75, 100 and
150mg)
M.R.P. Rs. As Per
SRO
Rs.8,000/20-10-2008.
Rs.12,000/Dy.No.427-R&I
dated 05-12-2014.
GABICA
Capsules 150mg
Getz
Anti-Epileptic.
597.
-do-.
Manufacturers
specifications
Pack size 14s

M.R.P. Rs. As Per
SRO
Pregab 25mg
Capsules
Form 5
Each Capsule
contains:
Pregabalin
... 25mg
Anti-Epileptic.
Manufacturers
specifications
598.
M/s Wel Wink

Pharmaceuticals,
G.T.
Road,
Industrial Estate,
Gujranwala Cantt.
Lyriwink 75mg
capsule
Each capsule
contains:
Pregabalin
75mg
(Anticonvulsant)
Rs.8,000/20-10-2008.
Rs.12,000/Dy.No.427-R&I
dated 05-12-2014.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50,
75, 100 and
150mg)
M.R.P. Rs. As Per
SRO
Form 5
Rs.20,000/08-01-2015
Dy. No. 209 R&I
Price: As fixed by
Government
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Latest
GMP
report required.
.
GABICA
Capsules (50, 75,
100, 150 and
235
inspection
Manufacturers
specifications
599.
M/s
Winbrains
Research
Laboratories
Hattar
Pregaba 100mg
capsule
Each capsule
contains:
Pregabalin
100mg
300mg)
Getz
Form 5
Dy. No. 439dated
27-05-11 R&I
Rs.8000/- dated 2405-11
12000/- dated 1107-14
(Anticonvulsant)
Manufacturers
specifications
Price: As fixed by
Government
Capsule section
granted
vide
letter No. F. 133/2006-Lic
dated
24th
September, 2012.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection of the
firm was carried
out on 17-03-14
by the FID and
nothing
was
reported
in
violation of GMP
compliance.
600.
M/s
Winilton
Pharmaceuticals,
Rawat Islamabad.
Pregaba 50mg
capsule
Each capsule
contains:
Pregabalin
50mg
Antiepileptic
Manufacturer
Form 5
Dy. No. 529dated
17-05-11 DDC(RIII)
Rs.8000/- dated 1005-11
12000/- dated 20106-14
As per leader price/
Pack of 10s
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Capsule section
granted
vide
letter No. F. 116/2007-Lic
dated 14th June,
2011
236
601.
-do-
Pregaba 100mg
capsule
Each capsule
contains:
Pregabalin
100mg
Antiepileptic
Manufacturer
602.
M/s
Hoover
Pharmaceuticals
Pvt. Ltd., Plot No.
16, Zain Park,
Industrial
Area,
Saggian
Bypass
Road, Lahore.
Form 5
Dy. No. 528dated
17-05-11 DDC(RIII)
Rs.8000/- dated 1005-11
12000/- dated 20106-14
As per leader price/
Pack of 10s
Neoglan Capsules
Form 5
Each Capsule
contains:
Rs.8000/Dated 20-11-2009
Pregabalin
..150mg
Rs.12,000/Dated 24-11-2014
Anticonvulsants
Price & Pack size

not mentioned
Manufacturers
specifications
Inspection of the
firm was carried
out on 16-12-14
by the area FID
and found GMP
compliant.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection of the
firm was carried
out on 16-12-14
by the area FID
and found GMP
compliant.
LYRICA
Capsules 150mg
US FDA
GABICA
Capsules 150mg
Getz
Capsule section
approval
vide
letter No: F.122/2008
(Lic)
th
dated 09 Dec
2009.
Inspection of the
firm was carried
out on 22-10-14
by the area FID
and
overall
condition of all
sections
was
maintained.
603.
-do-
Neoglan Capsules
Form 5
LYRICA
237
Each Capsule
contains:
Pregabalin
..75mg
Rs.8000/Dated 20-11-2009
Anticonvulsants
Rs.12,000/Dated 24-11-2014
Manufacturers
specifications
Price & Pack size

not mentioned
Capsules 75mg
US FDA
GABICA
Capsules 75mg
Getz
Case No: 2
Registration Board in the 246th meeting of Registration Board deferred the following product of M/s
PharmEvo (Pvt) Limited Karachi, for evaluation of registration application as approved checklist.
Sr.
No.
Name
and
address
of
Manufacturer /
Applicant
Brand Name
(Proprietary name +
Dosage
form
+
Strength)
Type of Form
Composition
Fee
including
differential fee
Pharmacological
Group
Demanded Price /
Pack size
International
status
in
stringent
regulatory
agencies
Remarks
Me-too status
Finished
product
specification
604.
M/s
PharmEvo
(Pvt)
Limited
Karachi .
AGLODA Tablet
25mg
Each film coated
tablet contains:
Agomelatine..25m
g
Antidepressant
Manufacturer
Form-5
Dy No: 255 dated
14-03-15
Rs.15000/- dated
17-04-10 Rs.5000/21-03-13
Rs.2690/10s,
3750/14s, 7500/
28s
GMP status as
depicted
in
inspection
report (dated)
Valdoxan 25 mg
film-coated
tablets
of
Serveir
Laboratories
Limited, UK
Valdoxan 25 mg
film-coated
tablets
of
Serveir
Laboratories
Limited,
Karachi
Tablet general
section
confirmation
vide letter No:
Inspection of the
firm was carried
out on April
2014- 10th March
2015 by the area
FID
and
he
concluded
that
the
premises,
equipment,
personnel, water
systems, HVAC
and
other
fundamental
elements of GMP
are found with
reasonable level
of compliance in
comparative
environment.
238
F2-1/98-Lic
(Vol-II)
dated
05-11-14
Case No: 3
Registration Board in the 243rd meeting of Registration Board deferred the following product of M/s
PharmEvo (Pvt) Limited Karachi, for evaluation of registration application as approved checklist.
Sr.
No.
Name
and
address
of
Manufacturer /
Applicant
Brand Name
(Proprietary name +
Dosage
form
+
Strength)
Composition
Type of Form
Fee
including
differential fee
International
status
in
stringent
regulatory
agencies
Remarks
Me-too status
Pharmacological
Group
Demanded Price /
Pack size
Finished
product
specification
605.
M/s The Searle

Company Limited
Karachi
NUBIN Injection
Each ml contains:
Nalbuphine
HCL..10mg
Opoid Analgesic
Form-5
Dy No:
Rs.8000/- dated 1711-08
Rs.12000/20-01-14
Manufacturer
As per DPC/ 10s
606.
-do-
NUBIN Injection
Each ml contains:
Nalbuphine
HCL..20mg
Opoid Analgesic
Form-5
Dy No:
Rs.8000/- dated 1711-08
Rs.12000/20-01-14
GMP status as
depicted
in
inspection
report (dated)
Nalbuphine
HCL inj
Hospira
of
Nabupin Inj of
Medicraft
pharmaceuticals
Inspection
of
firm was carried
out on 25th July
2013 by the panel
of inspectors and
recommended the
issuance of GMP
certificate.
Liquid Injection
ampoule general
Injection section
vide letter No
F.2-6/ 2000 Lic
dated
20th
October 2008
Nalbuphine
HCL inj
Hospira
of
Nabupin Inj of
Medicraft
pharmaceuticals
Inspection
of
firm was carried
out on 25th July
2013 by the panel
of inspectors and
recommended the
issuance of GMP
certificate.
239
Manufacturer
As per DPC/ 10s
Liquid Injection
ampoule general
Injection section
vide letter No
F.2-6/ 2000 Lic
dated
20th
October 2008
Case No: 04
Registration Board in its 247th meeting deferred the following products of M/s Tabros Pharma Karachi
due to following deficiencies. The firm has now rectified them and requested for registration.
Sr.
No.
Name
and
address
of
Manufacturer /
Applicant
Brand Name
(Proprietary name
+ Dosage form +
Strength)
Composition
Type of
Form
Initial
date,
diary.
International
status
in
stringent
regulatory
agencies
Decision
Remarks
1. Under master
formulation no
Sustained
Release
ingredient
has
been
claimed.
Apparently
formulation is for
immediate
release
formulation. 2.
Under limits for
uniformity
of
dosage
unit
merely NMT 15
mentioned.
3.
Details
of
reference
standard
being
used. 4. Before
The firm has

rectified the
deficiencies
mentioned in
the preceding
column
Me-too
Pharmacological
Group
Finished product
specification
Fee
including
differentia
l fee
Demanded
Price
/
Pack size
607.
M/s
Pharma
20/B,F.B.
Industrial
Karachi.
Tabros
LArea,
Allay SR Tablet
Tablet SR
Each SR tablet
contains: Tramadol
Hydrochloride
100mg
(Non Narcotic
Analgesic Agent)
Manufacturer
Form 5
Rs.8,000/15-08-2009
Dy. No. not
mentioned
Rs.12,000/28-11-2013
Dy. No. not
mentioned
Rs.280/10s
status
GMP status
as depicted in
inspection
report
(dated)
RAYZOLT
100mg
Extended
Release tablet
US FDA
TRAMAL
100mg
SR
tablet Searle
Tablet
(General)
section
approved as
per copy of
DML.
240
608.
-do-
Allay Tablet 50mg

Tablet
Each film coated
Tablet Contains:
Tramadol
Hydrochloride
.. 50.00mg
(Non Narcotic
Analgesic Agent)
Form 5
Rs.8,000/24-07-2009
Dy. No. not
mentioned
Rs.12,000/28-11-2013
Dy. No. not
mentioned
Rs.180/10s
ULTRAM
50mg tablet
US
FDA
TRADOL
50mg tablet
Pharmedic
Tablet
(General)
section
approved as
per copy of
DML.
marketing of the
product
an
undertaking
to
submit
comparative
dissolution
profile with the
established brand
and the data shall
be supported by
relevant
documents to the
DRAP which will
include:
a. Purchase of
raw material, b.
Certificate
of
Analysis,
c.
Testing protocols,
d.
SOPs,
e.
Analytical data
and f. Finished
Product sample.
1. Under limits
for uniformity of
dosage
unit
merely NMT 15
mentioned.
2.
Details
of
reference
standard
being
used.
The firm has

rectified the
deficiencies
mentioned in
the preceding
column
241
Case No.11: Stability studies submitted by different firms

Following firms have submitted stability data in the light of decision of registration board.
1. M/s Getz Pharma, Karachi
Drug
Source
Sofviget tablets (Sofosbuvir) 400 mg

Beijing Kawin Technology Share-Holding Co. Ltd,
China (Sofosbuvir Intermediate)
Real Time: 30 C and 75% RH
Accelerated: 40 C and 75% RH
Real Time: 6 months
Accelerated: 6 months
0, 3, 6 months
400 tablets
01
Not provided
Deferred in 244th meeting of Registration Board for
stability as per WHO/ICH guidelines
Storage Condition
Time Period
Frequency
Batch Size
No. of Batches
Sample Size
Meeting
COA of API states Sofosbuvir intermediate

Attributes Tested
Sr.
No.
1.
Attribute
Specifications
Appearance
2.
Identification
3.
Disintegration
time (mins)
Dissolution time
(mins)
Assay %
Yellow colored oblong shaped

film coated tablets
Retention time of the major
peak in the chromatogram
corresponds to that of
standard preparation
NMT 30 mins
4.
5.
NLT 75%
90-110%
Results
(Initial)
RT: Complied
A: Complied
RT: Complied
A: Complied
Results
(3 months)
RT: Complied
A: Complied
RT: Complied
A: Complied
Results
(6 months)
RT: Complied
A: Complied
RT: Complied
A: Complied
RT: 1.0
A: 1.0
RT: 91%
A: 91%
RT: 96%
A: 96%
RT: 1.0
A: 2.0
RT: 96%
A: 91%
RT: 97%
A: 97%
RT: 2.0
A: 2.0
RT: 96%
A: 96%
RT: 96%
A: 96%
2. M/s Hilton Pharma, Karachi

242
Drug
Source
Sofohil tablets (Sofosbuvir) 400 mg

Zheiejiang jianjbi Pharmaceutical Co, Limited
China, Wuxi Sigma Chemical Product Co. Ltd,
China
Real Time: 30 C and 65% RH
Real Time: 6 months
0, 1, 3, 6 months
500 Tablets, 2500 Tablets
02
Not provided
Deferred in 244th meeting of Registration Board for
stability as per WHO/ICH guidelines
Storage Condition
Time Period
Frequency
Batch Size
No. of Batches
Sample Size
Meeting
API import invoice cleared by Pakistan Customs only

Attributes Tested (Batch 1)
Sr.
No
.
1.
Attribute
Specifications
Results
(Initial)
Results
(1 months)
Results
(3 months)
Results
(6 months)
Appearance
RT:
Complied
A: Complied
RT: Complied
A: Complied
RT:
Complied
A: Complied
RT: Complied
A: Complied
2.
Dissolution
White colored
oblong shaped
film coated
tablets
NLT 85%
3.
Total
Degradation
Product
Assay %
RT: 98%
A: 98%
RT:
Complied
A: Complied
RT: 100%
A: 100%
RT: 98%
A: 98%
RT: Complied
A: Complied
RT: 98%
A: 98%
RT:
Complied
A: Complied
RT: 99%
A: 98%
RT: 99%
A: 94%
RT: Complied
A: Complied
5.
NMT 0.8%
90-110%
RT: 99%
A: 99%
RT: 96%
A: 98%

Sr.
No
.
1.
2.
3.
5.
Attribute
Specifications
Appearance
White colored oblong

shaped film coated tablets
NLT 85%
NMT 0.8%
Dissolution
Total
Degradation
Product
Assay %
90-110%
Results
(Initial)
Results
(3 months)
A: Complied
A: Complied
A: 95%
A: Complied
A: 94%
A: Complied
A: 100%
A: 99%
243
3. M/s Shrooq Pharma, Lahore

Drug
Source
Storage Condition
Time Period
Frequency
Batch Size
No. of Batches
Sample Size
Meeting
Sofvir tablets (Sofosbuvir) 400 mg

Virupaksha Organics Ltd. India
0, 1,2, 3, 4,5, 6 months
400/ batch
03
30 tablets
Deferred in 244th meeting of Registration Board

Sr.
No
.
1.
2.
3.
Attribute
Specification
s
Results
(Initial)
Appearance
White
colored
oblong
shaped film
coated
tablets
+ve
NMT 30
mins
685 mg
5.0%
90-110%
4.
Identification
Disintegratio
n time (mins)
Average Wt
5.
Assay %
Complie
d
Results
(1
months)
Complie
d
Results
(2
months)
Complie
d
Results
(3
months)
Complie
d
Results
(4
months)
Complie
d
Results
(6
months)
Complie
d
+ve
6
+ve
6
+ve
6
+ve
7
+ve
6
+ve
6
Complie
d
99%
Complie
d
99%
Complie
d
99%
Complie
d
99%
Complie
d
99%
Complie
d
99%

Sr.
No
.
1.
Attribute
Specification
s
Results
(Initial)
Appearance
White
colored
oblong
Complie
d
Results
(1
months)
Complie
d
Results
(2
months)
Complie
d
Results
(3
months)
Complie
d
Results
(4
months)
Complie
d
Results
(6
months)
Complied
244
2.
3.
4.
Identification
Disintegratio
n time (mins)
Average Wt
5.
Assay %
shaped film
coated tablets
+ve
NMT 30
mins
685 mg
5.0%
90-110%
+ve
6
+ve
6
+ve
6
+ve
7
+ve
6
+ve
6
Complie
d
99%
Complie
d
99%
Complie
d
99%
Complie
d
99%
Complie
d
99%
Complied
99%

Sr.
No
.
1.
2.
3.
Attribute
Specification
s
Results
(Initial)
Appearance
White
colored
oblong
shaped film
coated tablets
+ve
NMT 30
mins
685 mg
5.0%
90-110%
4.
Identification
Disintegratio
n time (mins)
Average Wt
5.
Assay %
Complie
d
Results
(1
months)
Complie
d
Results
(2
months)
Complie
d
Results
(3
months)
Complie
d
Results
(4
months)
Complie
d
Results
(6
months)
Complied
+ve
6
+ve
6
+ve
6
+ve
7
+ve
6
+ve
6
Complie
d
99%
Complie
d
99%
Complie
d
99%
Complie
d
99%
Complie
d
99%
Complied
99%
4. M/s Genix Pharma, Karachi

Drug
Source
Storage Condition
Time Period
Frequency
Batch Size
No. of Batches
Sample Size
Meeting
Sofo tablets (Sofosbuvir) 400 mg

Zhejiang Jiangbei, Pharmaceutical Co. Ltd China
(For trial purpose)
Real Time: 30C 2C/65% 5% RH)
6 months
0, 1, 3, 6 months
225/ batch
02
20 tablets per test
Deferred in 244th meeting of Registration Board
245
Accelerated Stability Study (40C 2C, 75% 5% RH)

Product: SOFO 400mg tablet
Mfg. Date: 09-2014
Date of Commencement: 12-09-2014
Product Code: NA
Exp. Date: 09-2016
Date of Completion: 12-03-2015
Batch No.: TR001
Shelf Life: 2 Years
Pack Size: 14s
Packaging: HDPE Bottle with Cap, pilfer-proof
Specifications No/Version: GENIXQC-SOP-SF-140/00
Reason For Stability: Trial batch for registration purpose and shelf life.
Parameters
Assay
Dissolution
Impurities
Disintegration
Physical Observation
Time
(minute)
Specification
s
Label Claim
NLT 80%
400mg/tablet
Unspecified NMT
0.5%
NMT 30
minutes
Oblong yellow biconvex

coated tablets engraved
Genix on one side plain
on other side.
2.39 mins
Complies
2.39 mins
Complies
2.41 mins
Complies
Total NMT 1.0%
Limits
(90%-110%)
Intervals
Initial Results
3rd month
6th month
99.19%
99.1%
99.44%
95.5%
99.21%
93.9%
ND
Unspecified Impurity
0.034%
Total Impurities
0.034%
0.182%
Total Impurities
0.182%
Real Time Stability Study (30C 2C/65% 5% RH)

Mfg. Date: 09-2014
Product Code: NA
Exp. Date: 09-2016
Batch No.: TR001
Shelf Life: 2 Years
Pack Size: 14s
Specifications No/Version: GENIXQC-SOP246
SF-140/00
Parameters
Specification
s
Assay
Label Claim
Dissolutio
n
Impurities
NLT 80%
Unspecified NMT
0.5%
400mg/table
t
Disintegration
Time (minutes)
NMT 30
minutes

Genix on one side plain
on other side.
Total NMT 1.0%
Limits
(90%-110%)
Intervals
Initial Results
99.19%
99.1%
ND
2.39 mins
Complies
3rd month
99.06%
96.6%
ND
2.27 mins
Complies
2.19 mins
Complies
6th month
99.0%
94.0%
0.186%
Total Impurities
0.186%
Accelerated Stability Study (40C 2C, 75% 5% RH)

Mfg. Date: 09-2014
Product Code: NA
Exp. Date: 09-2016
Batch No.: TR002
Shelf Life: 2 Years
Pack Size: 14s
Packaging: HDPE Bottle with

Cap, pilfer-proof
Specifications No/Version: GENIXQC-SOP-SF140/00
Parameters
Assay
Dissolution
Impurities
Disintegration
time
Specification
s
Label Claim
400mg/tablet
Limits
NLT 80%
Unspecified NMT
0.5%
Total NMT 1.0%
NMT 30
minutes

Genix on one side plain on
other side.
247
(90%-110%)
Intervals
Initial Results
3rd month
101.61%
99.7%
100.68%
6th month
ND
0.039%
96.7%
99.0%
Total Impurities
0.077%
0.179%
94.2%
Total Impurities
0.179%
2.41 mins
Complies
2.14 mins
Complies
2.10 mins
Complies
Real Time Stability Study (30C 2C/65% 5% RH)

Mfg. Date: 09-2014
Product Code: NA
Exp. Date: 09-2016
Batch No.: TR002
Shelf Life: 2 Years
Pack Size: 14s
Specifications No/Version: GENIXQC-SOPSF-140/00
Parameters
Assay
Dissolution
Impurities
Disintegration
time
Specifications
Label Claim
NLT 80%
400mg/tablet
Unspecified NMT
0.5%
NMT 30
minutes

Genix on one side
plain on other side.
Total NMT 1.0%
Limits
(90%-110%)
Intervals
Initial Results
101.61%
99.7%
ND
2.41 mins
Complies
3rd month
100.24%
96.5%
0.003%
2.40 mins
Complies
Total Impurities
248
0.003%
6th month
99.70%
92.3%
0.181%
2.31 mins
Complies
Total Impurities
0.181%
249
5. M/s Macter International Karachi

6.
7. Drug
8. Sofomac
tablets
(Sofosbuvir)
400 mg
10. Xiamen Co.
Ltd
12. Accelerated:
40 C and
75% RH
13. Real Time:
30C
2C/65%
5% RH)
15. 6 months
17. 0, 1, 3, 6
months
19. NA
21. 02
9. Source
11. Storage
Condition
14. Time Period

16. Frequency
18. Batch Size
20. No. of
Batches
22. Sample Size
24. Meeting
23. NA
25. Deferred in
244th meeting
of
Registration
Board
26.
27.
28.
29.
S
30.
31. 30C + 2C &

65% + 5% RH
250
32.
34.
33.
S
35. Feb-14
36.
38.
37.
1
39. Feb-16
40.
42.
41.
B
43.
44. Initial, 3 &

6 months
45.
46.
50.
47.
S
48.
251
51.
55.
52.
E
53.
54.
56.
57.
N
60.
58.
59.
65.
61.
62.
N
63.
64.
70.
66.
67.
S
68.
69.
71.
72.
73. Batch 2
252
74.
77.
75.
76.
S
78. 30C + 2C &

65% + 5% RH
79.
81.
80.
S
82. Feb-14
83.
85.
84.
1
86. Feb-16
87.
89.
88.
B
90.
91. Initial, 3 &

6 months
92.
93.
94.
S
95.
97.
253
98.
99.
E
100.
102.
comp
101.
103.
107.
104.
N
105.
106.
112.
108.
113.
109.
N
110.
114.
S
115.
111.
116.
117.
254
118.
119. Batch 3
120.
121.
124.
122.
123.
S
125. 30C + 2C
& 65% + 5%
RH
126.
127.
S
130.
128.
Feb-14
133.
Feb-16
132.
131.
1
134.
129.
135.
B
136.
137.
138. Initial, 3
& 6 months
255
139.
140.
144.
141.
S
142.
143.
145.
146.
E
150.
151.
N
147.
152.
148.
149.
comp
153.
154.
256
155.
160.
156.
N
157.
161.
S
162.
158.
159.
90.94
163.
164.
101.8
165.
169.
40
C
166.
P
167.
Sofo
m
a
c
4
0
0
m
g
T
a
b
l
e
t
s
+
2
C
168.
S
&
7
5
%
+
5
%
R
H
257
170.
B
174.
P
178.
P
172.
M
171.
S001
175.
14's
&
2
8
'
s
179.
Bottl
e
,
C
a
p
,
L
a
b
e
l
,
U
n
i
t
c
a
r
t
o
176.
E
180.
181.
173.
Feb
1
4
177.
Feb
1
6
182.
Initi
a
l
,
3
&
6
m
o
n
t
h
s
258
n
&
L
e
a
f
l
e
t
183.
185.
Spec
188.
184.
T
189.
P
190.
Elon
186.
187.
191.
192.
193.
com
259
195.
NM
198.
194.
D
199.
D
204.
A
196.
200.
NLT
205.
Sofo
201.
206.
197.
203.
90.6
202.
207.
208.
100.
260
209.
210.
211.
212.
213. Batch 2
214.
215.
P
216.
Sofo
m
a
c
4
0
0
m
g
T
a
b
l
217.
S
218.
40
C
+
2
C
&
7
5
261
%
+
e
t
s
219.
B
223.
P
227.
P
5
%
221.
M
220.
S002
224.
14's
&
2
8
'
s
228.
Bottl
e
,
C
a
p
,
L
a
b
e
l
,
225.
E
229.
230.
R
H
222.
Feb
1
4
226.
Feb
1
6
231.
Initi
a
l
,
3
&
6
m
o
262
U
n
i
t
c
a
r
t
o
n
&
n
t
h
s
L
e
a
f
l
e
t
232.
234.
Spec
237.
233.
T
235.
236.
263
239.
Elon
240.
238.
P
243.
D
244.
NM
245.
242.
com
241.
246.
247.
264
248.
D
249.
NLT
250.
251.
252.
91.4
256.
257.
101.
254.
Sofo
255.
253.
A
258.
259.
260.
261.
262.
263.
264.
265.
266.
267.
265
268. Batch 3
269.
273.
40
C
270.
P
274.
B
278.
P
271.
Sofo
m
a
c
4
0
0
m
g
T
a
b
l
e
t
s
275.
S003
279.
14's
&
2
+
2
C
272.
S
&
7
5
%
+
5
%
276.
M
280.
E
R
H
277.
Feb
1
4
281.
Feb
1
6
266
282.
P
8
'
s
283.
Bottl
e
,
C
a
p
,
L
a
b
e
l
,
U
n
i
t
c
a
r
t
o
n
&
286.
Initi
a
l
,
3
284.
&
285.
6
m
o
n
t
h
s
L
e
a
f
l
e
t
267
287.
289.
Spec
292.
288.
T
293.
P
294.
Elon
290.
291.
295.
296.
297.
com
268
299.
NM
298.
D
303.
D
308.
A
300.
304.
NLT
309.
Sofo
305.
310.
302.
10
301.
307.
90.7
306.
311.
312.
101.
269
313.
314.
315. M/s Brookes Pharma, Karachi
316.
317. D
rug
318. Tomex
(Dexmedetomidi
ne) Injection
ml
319. S
tora
ge
Con
ditio
n
322. T
ime
Peri
od
324. F
requ
ency
326. B
atch
Size
328. N
o. of
320. Accelerated: 40
C and 75% RH
321. Real Time: 30
C and 65% RH
323. Accelerated: 6
months
325. 0, 1,2, 3, 4,5, 6

months
327.
10 L
329.
270
Batc
hes
330. S
amp
le
Size
332. M
eeti
ng
331.
39 ampoules
333. Deferred
in
th
245 meeting of
Registration Board
for stability data as
per
WHO/ICH
guidelines
334.
335. Accelerated: 40 0 C+2 0C, RH 75+ 5 %
336.
338.
P
e
r
i
o
d
339.
346.
347.
340.
348.
349.
S
ubstan
ces
352.
353.
350.
355.
356.
354.
351.
358.
I
n
i
t
i
a
359.
363.
364.
365.
366.
271
367.
l
370.
1
372.
376.
378.
st
371.
m
o
n
t
h
s
383.
2
385.
392.
401.
411.
n
d
384.
M
o
n
t
h
s
399.
3
r
d
400.
M
o
n
t
272
h
s
419.
6
421.
435.
438.
439.
t
h
420.
M
o
n
t
h
s
440.
441.
442. Real Time: 30 C and 65% RH
443.
445.
P
e
r
i
o
d
449.
455.
459.
456.
460.
462.
454.
461.
457.
458.
273
463.
465.
I
n
i
t
i
a
l
477.
1
467.
471.
472.
473.
474.
480.
484.
485.
493.
497.
499.
s
t
478.
m
o
n
t
h
s
490.
2
n
d
491.
M
o
n
t
h
498.
274
s
506.
3
509.
515.
518.
r
d
507.
M
o
n
t
h
s
526.
6
516.
517.
530.
538.
542.
545.
t
h
527.
M
o
n
t
h
s
539.
540.
541.
547.
548.
549.
550. Cis-Curon Injection (Cis-AtracuriumBesylate) 5 ml

551.
552. S
tora
ge
553. Accelerated: 25
C and 60% RH
554. Real Time: 2-8
275
546.
Con
ditio
n
555. T
ime
Peri
od
557. F
requ
ency
559. B
atch
Size
561. N
o. of
Batc
hes
563. S
amp
le
Size
565. M
eeti
ng
556.
6 months
558. 0, 1,2, 3, 6
months
560.
10 L
562.
564.
29 ampoules
566. Deferred in
245th meeting of
Registration Board
567.
568.
569.
570.

571.
572.
573.
574.
575.
576.
577.
276
585.
578.
580.
579.
588.
587.
582.
586.
581.
589.
591.
590.
596.
597.
598.
605.
606.
607.
600.
599.
609.
608.
621.
614.
615.
616.
622.
618.
617.
Significant change noticed in assay of product

623.
624.
625. Real Time: 2-8 C
626.
635.
630.
627.
628.
629.
637.
638.
639.
647.
648.
649.
657.
658.
659.
632.
636.
631.
640.
642.
641.
650.
652.
651.
660.
662.
661.
277
675.
670.
667.
668.
676.
672.
669.
671.
677.
678.
679.
680.
681.
682.
683.
684.
685. M/s Pharmatec Pakistan (Pvt) Ltd, Karachi
686.
687. Maltofer Fol Syrup

688.
689.
Stora
g
e
C
o
n
d
690. Accelerated:
40 C and 75%
RH
691. Real Time: 30
C and 65% RH
278
i
t
i
o
n
692.
Time
P
e
r
i
o
d
694.
Freq
u
e
n
c
y
696.
Batc
h
S
i
z
e
698.
No.
o
f
693.
6 months
695. 0, 1,2, 3, 6
months
697. 300 L per

batch
699.
279
B
a
t
c
h
e
s
700.
Sam
p
l
e
S
i
z
e
702.
Meet
i
n
g
701. 20 packs per

batch
703. Deferred in
245th meeting of
Registration
Board for
stability data as
per WHO/ICH
guidelines
704.
705.
Accelerated: 40 C and 75% RH (Batch 1)

707.
708.
Ini
tial
712.
711.
713.
715.
717.
709.
Re
sult
280
718.
719.
720.
721.
726.
737.
736.
738.
722.
723.
724.
759.
760.
764.
765.
762.
767.
729.
742.
743.
748.
749.
745.
751.
753.
754.
755.
756.
757.
758.
739.
740.
741.
281
770.
771.
772.
773.
774.
775.
776.
777.
Real Time: 30 + 2 0 C, 65 + 5 % (Batch 1)
779.
794.
782.
783.
785.
787.
789.
791.
793.
799.
800.
801.
802.
834.
835.
840.
841.
845.
846.
851.
861.
837.
843.
848.
797.
805.
807.
818.
829.
819.
817.
780.
Initi
al
781.
Res
ult
830.
831.
832.
855.
833.
282
865.
870.
871.
872.
873.
876.
877.
878.
879.
Accelerated: 40 + 2 0C and 75%+ 5 % RH (Batch 2)

880.
881.
Initi
al
882.
884.
886.
888.
890.
896.
897.
933.
938.
Res
ult
891.
892.
898.
899.
905.
910.
906.
907.
893.
894.
915.
916.
921.
922.
926.
927.
924.
929.
918.
935.
940.
911.
283
908.
909.
912.
913.
914.
942.
943.
944.
945.
946.
947.
948.
949.
950.
951.
953.
969.
Real Time: 30 + 2 0 C, 65 + 5 % (Batch 2)

954.
I
nitial
955.
R
esult
970.
957.
959.
961.
963.
965.
967.
971.
972.
973.
974.
975.
976.
284
979.
992.
997.
998.
1000.
991.
1003.
1004.
1008.
1009.
1014.
1015.
1006.
1011.
1017.
1020.
1025.
1031
1022.
993.
1028.
1034
1043.
1044
994.
995.
996.
1037.
1038.
1039.
1040.
1041.
1042.
1045.
285
1046.
1047. Accelerated: 40 + 2 0C and 75%+ 5 % RH (Batch 3)
1049.
Spe
1060.
1061.
Dar
1050. I
nitial
1051. R
esult
1062.
1053.
1055.
1057.
1059.
1063.
1064.
1065.
1066.
1069.
5.0
286
1080.
100.
1085.
1086.
1091.
1092.
1096.
1097.
1102.
1103.
1088.
1094.
1099.
1105.
1108.
1110.
1079.
1081.
(90.
287
1082.
1083.
400
1084.
(340
1113.
Less
1114.
1115.
1116.
1117.
1118.
288
1119.
1120. Real Time: 30 + 2 0 C, 65 + 5 % (Batch 3)
1122.
1138.
1123. I
nitial
1124. R
esult
1139.
1126.
1128.
1130.
1132.
1134.
1136
1140.
1141.
1142.
1143.
1144.
1145.
1166.
1167.
1172.
1173.
1177.
1178.
1183.
1184.
1189.
1194.
1200
1169.
1175.
1180.
1186.
1148.
1161.
1160.
1162.
1191.
1197.
289
1203
1163.
1164.
1165.
1206.
1207.
1208.
1209.
1210.
1211.
1212.
1214.
1215.
1216. M/s Global Pharmaceutical, Islamabad
1217. Drug
1220. Storage
Condition
1218. Dlanz
Capsule 30
mg
1219. Dlanz
Capsule 60
mg
1221. Accelerate
d: 40 C and
290
1213
1223. Time
Period
1225. Frequency
1227. Batch Size
1229. No. of
Batches
1231. Sample
Size
1233. Meeting
75% RH
1222. Real
Time: 30 C
and 65% RH
1224. 12 months
and 20
months
1226. 0,3,6,9,12,
20 months
1228. 10000
Caps
1230. 03
1232. 50 packs
per batch
1234. Registratio
n
Board
approved the
products.
However, the
Board
advised
concerned P
E
&
R
Division and
Incharge,
PEC
to
evaluate
submitted
stability
studies
of
Zone IVA of
291
Dexlansopraz
ole 30 &
60mg
Capsule.
Registration
Board
authorized its
Chairman for
subsequent
approval for
issuance of
registration
letter.
1235.
(246
meeting
of
registration
board)
1237. Assay
conducted
on
spectrophoto
meter
1236. Remarks
1238.
1239. DLanz Capsule 30mg

1240.
t
Produc
1241. DLanz
DDR
1244.
De
Capsule
30mg
1242.
1243.
B#T-
1245. Almost White Spherical

DDR Pellets 17%, filled
1246.
1247.
1000
292
EHG Capsule size 4

with Cap Green & Body
Yellow; Blister in Alu-Alu
Aluminium Foil, 7s packed
in Printed Unit Carton along
With Leaflet.
1250.
1251.
DLP
1254.
1255.
Mar,
1257. As per In House

specification
1258.
1259.
Feb,
1260.
St
1261. 30+ 2C and 65% + 5%

RH (Long Term Stability)
1262.
1263.
50
1264.
D
1265. 16-3-2014
1266.
1267.
12-
1256. Parameters
and tests monitored
293
1268.
1281.
1269.
1271.
1270.
T
1272.
L
Description
1288.
1289.
I
D
issoluti
on
1296.
1297.
0.1 N
HCl
1305.
Buffer
pH 7.0
1318. Assay of
Dexlansoprazole
1273. RESULTS OF ANALYSIS

1276.
1282. Almost White

Spherical Pellets filled
inEHG Capsule size
4 with Cap Green &
Body Yellow.
1290. Absorption
spectrum obtained from
assay preparation and
reference preparation
shows absorption
maximum at wave
length 292 nm.
1283.
1291.
1298. After 2 Hour

NMT 10%
1299.
1306.
1308.
After 1 Hour
NLT 35%
1307. After 3 Hour
NLT 70%
1319. 90.0 110.0 %
1309.
1320.

1326.
Product
1327. DLanz
DDR
Capsule
30mg
1328.
1329.
294
1330.
D
1332.
1333.
1336.
1337.
1340.
1341.

specification
1344.
1345.
1346.
S
1347. 30+ 2C and 65% + 5%

1348.
1349.
1350.
D
1351. 10-06-2013
1352.
1353.
1342. Parameters and

tests monitored

EHG Capsule size 4 with
Cap Marron & Body White;
Blister in Alu-Alu Aluminium
Foil, 7s packed in Printed
Unit Carton along With
Leaflet.
1354.
1355.
1356.
1357.
1358. L
IM
IT
S
295
1368.
1375.
C
o
m
p
li
e
s
1369. Almost
White
Spherical Pellets filled inEHG
Capsule size 4 with Cap
Marron & Body White.
Description
1376.
1378. Absorption spectrum

obtained from assay
preparation and reference
preparation shows absorption
maximum at wave length 292
nm.
1377.
Id
1386.
0.1
N
H
Cl
1385. D
1395.
issoluti
Bu
on
ffe
r
p
H
7.0
1412. Assay of
Dexlansoprazole
1387.
1396.
1397.
After 2 Hour NMT

10%
After 1 Hour NLT 35%

After 3 Hour NLT 70%
1413.
90.0 110.0 %

1421.
Product
1422. DLanz
DDR
1425.
D
Capsule
30mg
1423.
1424.

1427.
1428.
296

Cap Marron & Body White;
Blister in Alu-Alu Aluminium
Foil, 7s packed in Printed
Unit Carton along With
Leaflet.
1431.
1432.
1435.
1436.

specification
1439.
1440.
1441.
S
1442. 40+ 2C and 75% + 5%

1443.
1444.
1445.
D
1446. 10-06-2013
1447.
1448.

tests monitored
1449.
1450.
1451.
Test
Li
1460.
1461.
Des
Al
1452. Result of Analysis

1457.
1463.
1464.
1465.
1466.
1467.
1462.
Ca
297
1468.
1471.
Ide
Ab
1472.
1473.
1474.
1475.
1476.
1469.
1470.
1477.
1480.
1481.
1484.
Af
298
1488.
1490.
Af
1493.
1494.
1495.
1496.
1489.
1497.
1499.
1500.
1501.
1502.
1508.
1509.
1498.
1491.
Af
1492.
1503.
1504.
Ass
90.
1505.
1506.
1507.
299
1510.
1511.

1513.
Product
1514. DLanz
DDR
1517.
D

tests monitored
1533.
S
Capsule
60mg
1515.
1516.

Cap Purple & Body Dark
Purple; Blister in Alu-Alu
Aluminium Foil, 6s packed
in Printed Unit Carton along
With Leaflet.
1519.
1520.
1523.
1524.
1527.
1528.

specification
1531.
1532.
1534. 30+ 2C and 65% + 5%

1535.
1536.
300
1537.
D
1538. 15-07-2013
1539.
1540.
1541.
1542.
1544.
1543.
T
1545.
LI
1556. Almost
White
Spherical Pellets filled
1555. Description
EHG Capsule size 1
with Cap Purple & Body
Dark Purple
1563.
1565. Absorption
spectrum obtained from
1564.
assay preparation and
reference preparation
shows absorption
maximum at wave length
292 nm.
1573.
0.1
1574. After 2 Hour NMT
N
10%
H
Cl
1572. D
1582.
issoluti
Bu
1583. After 1 Hour NLT
on
ffe
35%
r
1584. After 3 Hour NLT
p
70%
H
7.0
301
1599. Assay of
Dexlansoprazole
1600.
90.0 110.0 %
1608.
1609.
1610.
1611.
1612.
1613.
1614.
1615.
1616.
1617.
1618. M/s Sanofi Aventis Pakistan, Karachi
1619. Drug
1621. Storage
Condition
1625. Time
Period
1620. Flagyl
Suspension
1622. Accelerated:
40 0C and 75%
RH
1623. Real Time:
25 0 C, 60 RH
1624. (Not as per
Zone IV-A)
1626. 06 months
302
1627. Frequen
cy
1629. Batch
Size
1631. No. of
Batches
1633. Sample
Size
1635. Meetin
g
1628. 0, 3, 6, 12, 24
months
1630. 500 L per
batch
1632. 03
1634. 30 packs per
batch
1636. Deferred in
247th meeting of
registration
board
for
evaluation
of
data as per
WHO/ICH
Guidelines
(Change
in
flavor)
1637.
1638.
1652.
1639.
1643. 06 Months
1654.
1655.
1656.
1657.
1658.
1659.
1662.
1663.
1664.
1665.
1666.
1667.
1670.
1671.
1672.
1673.
1674.
1675.
1678.
1679.
1680.
1681.
1682.
1683.
1686.
1687.
1688.
1689.
1690.
1691.
303
1694.
1701.
1724.
1695.
1696.
1697.
1698.
1699.
1755.
1756.
1702.
1710.
1718.
1726.
1734.
1742.
1750.
1751.
1752.
1753.
1754.
1759.
1760.
1761.
1762.
1763.
1764.
1767.
1768.
1769.
1770.
1771.
1772.
1749.
Significant change in assay noticed in batch 1 and 2

1773.
304
1774. M/S AMARANT PHARMA

1775. Drug
1776. Asenap
5mg Tablet
1778. Accelerat
ed: 40
2/75 5
RH
1779. Real
Time: 30
2/65 5
RH
1781. 06
months
1783. 0, 3, 6
months
1785. 10,000
tablets
1787. 01
1777. Storage
Condition
1780. Time
Period
1782. Frequenc
y
1784. Batch
Size
1786. No. of
Batches
1788. Sample
Size
1790. Meeting
1792.
1789. 185
1794.
1797.
1795.
1796.
1800. Accelerated: 40 2/75 5 RH
1791. Deferred
in 245
meeting of
registration
board for
stability as
per
WHO/ICH
guidelines
1798.
1799.
1801.
1804.
Speci
1803.
1805.
305
1809.
1810.
Whit
1812.
1814.
1816.
306
1818.
1819.
15
1820.
1824.
1825.
NMT
1830.
1831.
NLT
1836.
1837.
NMT
1842.
1844.
1832.
1833.
1834.
1845.
1846.
1847.
1853.
1854.
1843.
1849.
1851.
90.0
1850.
307
1855.
1856.
1859. Real Time:
1860.
1857.
30 2/65 5 RH
1863.
S
1870.
1871.
W
1879.
1880.
1885.
1886.
N
1891.
1892.
N
1897.
1898.
N
1903.
1905.
1904.
1910.
1911.
1858.
1912.
9
1864.
1866.
1868.
1873.
1875.
1877.
1893.
1894.
1895.
1906.
1907.
1908.
1914.
1915.
1916.
1917.
1918. M/s GlaxoSmithKline, Karachi
1919. Drug
1922. Storage
Condition
1925. Time
1920. Chewcal
Tablet
1921. Registratio
n No.019881
1923. Accelerate
d: 40
2/75 5 RH
1924. Real
Time: 30
2/65 5 RH
1926. 06 months
308
Period
1927. Frequency
1928. 0,3,6
months
1930. NA
1932. 03
1929. Batch Size

1931. No. of
Batches
1933. Sample
Size
1935. Meeting
1934. NA
1936. Deferred
in 245
meeting of
registration
board (For
grant of
additional
strawberry
flavor)
1937.
1938.
1940.
1939.
1941.
Che
1943.
Ingr
1942.
(Str
309
1951.
1947.
03
1948.
Calc
1952.
03
1953.
Vita
1954.
1957.
1959.
1958. Amber glass bottle contained in Carton

1960. Batch 1:
1961.
1962.
1963.
1964.
1966.
1965.
1967.
310
1975.
1980.
1982.
1983.
1992.
1993.
311
1999.
2004.
2005. Batch 2:
2006.
2007.
2008.
2009.
2010.
2012.
2011.
2013.
312
2020.
2025.
2027.
2028.
2037.
2038.
313
2044.
2049.
2050.
2051.
314
2052.
2053.
2054. Batch 3:
2055.
2056.
2057.
2058.
2059.
2061.
2060.
2062.
315
2069.
2074.
2076.
2077.
316
2086.
2087.
2093.
2098.
2099.
2100.
2101. M/s Novartis Pharma Karachi

2102.
2103. Drug
2105. Storage
Condition
2108. Time
Period
2110. Frequency
2112. Batch Size
2114. No. of
Batches
2116. Sample
Size
2118. Meeting
2104. CaC 1000

Plus
2106. Accelerate
d: 40
2/75 5 RH
2107. Real
Time: 30
2/65 5 RH
2109. 06 months
2111. 0, 3, 6
months
2113. NA
2115. 03
2117. NA
2119. Deferred
in 248
meeting of
registration
board for
evaluation of
stability data
(change in
packaging
317
material)
2120.
2121.
2122.
2123.
2124. Batch No.1
2125. Results (Accelerated Studies)
2126.
Test
2127.
2128.
2129.
2131.
App
2132.
2133.
2134.
2136.
D.T
2137.
2138.
2139.
2141.
Ord
2142.
2143.
2144.
318
2146.
Tast
2147.
2148.
2149.
2151.
Lod
2152.
2153.
2154.
2156.
Deg
2157.
2158.
2159.
2161.
Assa
2162.
2163.
2164.
2166.
Assa
2167.
2168.
2169.
2171.
2172.
2173.
2174.
319
Assa
2176.
Assa
2177.
2178.
2179.
Upper limits (assay) of Vit D3 and B6 not provided

2181.
2182. Batch No.1
2183. Results (Real Time Studies)
2184.
Test
2185.
2186.
2187.
2189.
App
2190.
2191.
2192.
320
2194.
D.T
2195.
2196.
2197.
2199.
Ord
2200.
2201.
2202.
2204.
Tast
2205.
2206.
2207.
2209.
Lod
2210.
2211.
2212.
2214.
Deg
2215.
2216.
2217.
2219.
Assa
2220.
2221.
2222.
321
2224.
Assa
2225.
2226.
2227.
2229.
Assa
2230.
2231.
2232.
2234.
Assa
2235.
2236.
2237.

2239.
322
2240.
323
2241. Batch No. 2

2242. Results (Accelerated Studies)
2243.
Test
2244.
2245.
2246.
2248.
App
2249.
2250.
2251.
2253.
D.T
2254.
2255.
2256.
2258.
Ord
2259.
2260.
2261.
2263.
Tast
2264.
2265.
2266.
2268.
Lod
2269.
2270.
2271.
2273.
2274.
2275.
2276.
324
Degr
2278.
Assa
2279.
2280.
2281.
2283.
Assa
2284.
2285.
2286.
2288.
Assa
2289.
2290.
2291.
2293.
Assa
2294.
2295.
2296.
325

2298.
2299. Batch No. 2
2300. Results (Real Time Studies)
2301.
Test
2302.
2303.
2304.
2306.
App
2307.
2308.
2309.
2311.
D.T
2312.
2313.
2314.
2316.
Ord
2317.
2318.
2319.
326
2321.
Tast
2322.
2323.
2324.
2326.
Lod
2327.
2328.
2329.
2331.
Degr
2332.
2333.
2334.
2336.
Assa
2337.
2338.
2339.
2341.
Assa
2342.
2343.
2344.
2346.
Assa
2347.
2348.
2349.
327
2351.
Assa
2352.
2353.
2354.

2356.
2357.
2358.
2359.
2360.
2361.
328
2362. M/ s Helix Pharma (pvt) Ltd Karachi

2363. Drug
2365. Storage
Condition
2368. Time
Period
2370. Frequenc
y
2372. Batch
Size
2374. No. of
Batches
2376. Sample
Size
2378. Meeting
2364. Raspro
Tablets 500
mcg
2366. Accelerate
d: 40
2/75 5 RH
2367. Real
Time: 30
2/65 5 RH
2369. 06 months
2371. 0, 3, 6
months
2373. NA
2375. 01
2377. NA
2379. Deferred
in 246th
meeting of
registration
board for
stability data
as pe
WHO/ICH
2380.
329
2381. Accelerated: 40 2/75 5 RH

2383.
A
2384.
2386.
2389.
2391.
Di
2387.
2385.
2395.
2392.
(
2393.
In
2397.
P
2399.
2401.
2403.
95
2404.
2411.
2414.
97
2415.
2421.
2426.
95
2427.
2434.
2438.
93
2439.
2398.
2400.
2406.
2408.
2407.
P
2409.
2417.
2410.
2419.
2418.
P
2420.
2429.
2431.
2430.
P
2432.
330
2441.
P
2433.
2442.
2445.
2450.
91
2451.
2443.
2444.
2452.
2453. Real Time: 30 2/65 5 RH
2455.
A
2456.
2458.
2463.
2461.
2459.
2467.
2457.
2464.
2465.
2469.
P
2471.
2473.
2476.
2477.
2487.
2488.
2475.
2470.
2472.
2479.
2481.
2484.
2480.
P
2482.
331
2490.
2483.
2492.
2494.
2499.
2500.
2507.
2512.
2513.
2519.
2522.
2523.
2529.
2531.
2532.
2543.
2544.
2491.
P
2493.
2502.
2504.
2503.
P
2511.
2505.
2514.
2515.
P
2506.
2516.
2517.
2524.
2525.
P
2518.
2526.
2527.
2533.
2534.
P
2528.
2537.
2539.
2541.
2535.
2538.
2536.
2545.
332
2546. M/ s Semose Pharmaceuticals (pvt.) Ltd Karachi

2547. Firm
2548. M/ s
Semos
pharmaceutic
als (Pvt.) Ltd
Karachi
2550. Asen
Tablet 5mg
2552. Shanghai
Yongyi Bio
Technology
China
2554. 40 C 2
C & 75%
RH (relative
humidity)
2556. 06 Months
2549. Drug
2551. Source
2553. Storage
Condition
2555. Time
Period
2557. Frequency
2559. Batch Size
2558. 1,2,3,6
2560. Not
provided
2562. 03
2561. No. of
Batches
2563. Sample
Size
2565. Meeting
2564. Not
provided
2566. M-245th
2567.
2568.
2569.
2570.
2571.
2572.
2573.
2574.
2575.
2576.
2577.
2578.
2579.
2580.
2581.
2582.
2583.
333
2584.
2585.
2586.
2587.
2588.
2589.
2590.
2591.
2592.
2593.
2594.
2595.
2596.
2597.
2598.
2599.
2600.
2601.
2602.
2603.
2604.
2605.
2606.
2607.
2608.
2609.
2610.
2611.
2612.
2613.
2614.
2615.
2616.
2617.
2618.
2619.
2620.
2621.
2622.
2623.
2624.
2625.
2626.
2628.
2629.
2630.
2631.
2632.
334
2627.
2633.
2634.
2637.
2638.
2639.
2640.
2641.
2642.
2645.
2646.
2647.
2648.
2649.
2650.
2635.
2636.
2643.
2644.
2651. REMARKS: Firm has submitted 6 months data before completion of 6 months period after import of raw
material.
2652.
2653.
2654.
335
2655. M/ s Searle Company Ltd Karachi

2656. Firm
2657. M/ s
Searle
Company Ltd
Karachi
2659. Sobvi
400mg
2661. Beijing
Huikang
bayuan
chemical
limited China
2663. Acclarted
and Real
Time (Zone
IV-A)
2665. 06 Months
2658. Drug
2660. Source
2662. Storage
Condition
2664. Time
Period
2666. Frequency
2667. 03 Months
Interval
2669. Nil
2671. 03
2668. Batch Size

2670. No. of
Batches
2672. Sample
Size
2674. Meeting
2673. Nil
2675. M-244th
2676.
2677. Stability Data Report
2678.
2679.
2680. Specifi
cations
2681.
2682.
2683.
336
2688.
2687.
2689.
2694.
2695.
2690. Yellow
color,
biconvex,
oblong
shaped,
filmcoated
tablets,
breakline
on one
side and
plain on
other side.
2691.
2696. 400mg
/tab
2697. 90% to
110% of
L.C
2698.
2692.
2693.
2699.
2700.
2704.
2705.
101.72%
2701.
2702. NMT
30 mins
2703.
337
2706.
2707. NLT
75%
released in
60minutes
2711.
2708.
2710.
2709.
Ambient Condition: 30C + 2C / 65% RH + 5% RH
2712.
338
2717.
2716.
2713.
2723.
2714. Spe
cificati
ons
2724. Yell
ow
color,
biconv
ex,
oblong
shaped,
filmcoa
ted
tablets,
breakli
2722.
Accel
2715.
2721.
2725.
2726.
2727.
Com
339
ne on
one
side
and
plain
on
other
side.
2730. 400
mg /tab
2728.
2734.
101.9
2733.
2731. 90%
to
110%
of L.C
2729.
2735.
2736. NM
T 30
mins
2741. NLT
75%
release
d in
60minu
tes
2740.
2732.
101.72%
2737.
2742.
2739.
6.0
2738.
2743.
2744.
95.88
2745.
2746.
2747.
Accelerated Condition: 40C + 2C / 75% + 5% RH

2748. Specifications
2749.
2750.
2751.
340
2757.
2758.
Yellow color,
biconvex, oblong shaped, filmcoated tablets,
breakline on one side and plain on other side.
2759.
2755.
2756.
2760.
2761.
2767.
2768.
2772.
2773.
2762.
2764. 400mg
/tab
2763.
2765. 90% to
110% of
L.C
2766.
101.85%
2769.
2770. NMT
30 mins
2771.
341
2774.
2775. NLT
75%
released in
60minutes
2776.
2777.
2778.
2779.
2780.
2781.
2782.
Specifications
2783.
2784.
2785.
2789.
Accel
2790.
Accel
342
2791.
2796.
2797.
2792. Yel
low
color,
bicon
vex,
oblon
g
shape
d,
filmco
ated
tablets
,
breakl
ine on
one
side
and
plain
on
other
side.
2793.
2798. 40
0mg
/tab
2799. 90
% to
110%
of L.C
2800.
101.85%
2794.
Comp
2795.
Com
2801.
101.7
2802.
101.3
343
2803.
2804. N
MT
30
mins
2809. NL
T 75%
releas
ed in
60min
utes
2808.
2806.
2807.
6.0
2811.
90.69
2812.
94.82
2805.
2810.
2813.
2814.
2815.
2825.
2816.
Specifications
2826. Yellow
color,
biconvex,
oblong
shaped,
filmcoated
tablets,
breakline on
one side and
plain on
2818.
2819.
2823.
2824.
2828.
2829.
2817.
2827.
344
other side.
2830.
2832. 400mg
/tab
2831.
2833. 90% to
110% of
L.C
2834.
2835.
2836.
2839.
2840.
2841.
2844.
2845.
2846.
101.68%
2837.
2838. NMT 30
mins
2842.
2843. NLT
75%
released in
60minutes
2847.
2848.
2849.

2850. Sp
ecifica
tions
2851.
2852.
2853.
345
2859.
2860. Yel
low
color,
bicon
vex,
oblon
g
shape
d,
filmco
ated
tablets
,
breakl
ine on
one
2861.
2857.
Accel
2858.
Accel
2862.
Com
2863.
Com
346
side
and
plain
on
other
side.
2866. 40
0mg
/tab
2864.
2865.
2867. 90
% to
110%
of L.C
2871.
2872. N
MT
30
mins
2877. NL
T
75%
releas
ed in
60min
utes
2876.
2868.
101.68%
2869.
101.3
2870.
100.5
2874.
2875.
7.0
2879.
90.33
2880.
94.35
2873.
2878.
2881.
2882.
347
B. Miscelleneous cases.
2883.
2884.
Registration-I
Case No. 01. Drugs deferred by Registration Board for expert

opinion.
2885. a.
Essentiale Fort Capsule 300mg

2886.
Registration Board in its 244th meeting
deferred following products for expert opinion. Accordingly

products were referred for views. Comments are as under:2887.
2889.
2891.
Name
2894.
2896.
2906.
2909.
2890.
2892.
Comp
2893.
2898.
2902.
Essent
2910.
2899.
2911.
2912.
348
2900.
2903.
Each
2901.
2904.
Phosp
349
2905.
2914.
2915.
D
2919.
P
2923.
D
2916.
E
2920.
P
2924.
P
2917.
P
2921.
R
2925.
B
2918.
2922.
R
2926.
2927.
E
2930.
E
2931.
E
2932.
350
2928.
D
I
2933.
2929.
T
2934.
2935. Submitted for consideration of Registration Board.
2936. b.
Skineal Cream & Haicneal Lotion.

2937.

2940.
2942.
Nam
2945.
2947.
2941.
2943.
Com
2944.
351
2949.
2952.
Skine
2959.
2964.
2960.
2965.
2961.
2962.
2953.
Each
2950.
2954.
Ketoc
2951.
2955.
Clobe
2956.
Propi
352
2957.
Neo
2958.
(Anti
2969.
2972.
Haicn
2979.
2982.
2980.
2983.
2973.
Each
2970.
353
2974.
Ketoc
2971.
2975.
Clobe
2976.
(Anti
354
2977.
2978.
2986.
2987.
B
2992.
P
2996.
D
2988.
C
2993.
P
2997.
C
2989.
M
2994.
P
2998.
A
2990.
R
2995.
2999.
F
2991.
3000.
I
3001.
3002.
T
3007.
E
3008.
S
355
3003.
T
3009.
T
3004.
N
3010.
B
3005.
D
3006.
I
3011.
c. Trittico (Trazodone HCl) 75mg & 150mg Prolonged-Release Tablets
3013.
3014.

3017.
3019.
3022.
3024.
3018.
3020.
3021.
356
3026.
3030.
3036.
3038.
3039.
3027.
3040.
3028.
3031.
3029.
3032.
3033.
3042.
3034.
3035.
3045.
3051.
3053.
3054.
3043.
3044.
357
3046.
3047.
3048.
3049.
3050.
3055.
3056.
P
3061.
P
3066.
H
3057.
H
3062.
P
3067.
A
3058.
P
3063.
F
3068.
K
3059.
I
3064.
Is
3069.
3060.
3065.
358
3070.
I
3072.
T
3071.
I
3073.
T
3076.
A
3074.
T
3075.
I
3077.
3078. 5th reminder issued to Head of Psychiatry Department, Aga Khan University
Hospital, Karachi on 16th April, 2015 but reply is still pending.
d. Hidrasec 10mg, 30mg Sachet and Hidrasec Capsule 100mg- M/s. Abbott
Laboratories.
3080.
Registration Board in its 246th meeting deferred
following products for expert opinion. Accordingly products
were referred for views. Comments are as under:3082.
3084.
Nam
3087.
3089.
3083.
3085.
Com
359
3086.
3091.
3094.
Hidr
3098.
3100.
3101.
3092.
3093.
3095.
Each
360
3096.
Race
3097.
(Anti
3104.
3107.
Hidr
3111.
3113.
3114.
3105.
3106.
361
3108.
Each
3109.
Race
3110.
(Anti
3117.
3120.
Hidr
3124.
3125.
3127.
362
3128.
3118.
3119.
3121.
Each
3122.
Race
363
3123.
(Anti
3130.
3131.
P
3135.
P
3141.
B
3132.
H
3136.
P
3142.
M
3133.
P
3137.
R
3143.
R
3134.
I
3138.
B
3144.
3139.
M
3140.
3145.
I
3146.
H
3149.
H
3147.
3150.
3148.
T
3151.
C
3152.
T
364
3153.
T
3154.
3155.
3156. The case was presented before the Registration Board in
247th meeting and deferred the case for presentation in
forthcoming meeting along with claims regarding indications,
side effects, contra indications of the applied product.
3157. As per dossier of the firm the indications, side effects,
contra indications of the applied product are as under;
3159. Hi
drase
c
10mg
Sach
et
and
3160. Hi
drase
c
30mg
Sach
et
3164. In
dicati
ons;
3165. Co
mple
menta
ry
sympt
omati
c
treat
ment
of
acute
diarrh
3161. Hidra
sec
100mg
Capsules
3162.
3166.
3167. Sympt
omatic
treatment
of acute
diarrhea
in adults.
365
ea in
infant
s
(older
than
3
mont
hs)
and
in
chlidr
ens
when
oral
rehyd
ration
and
the
usual
suppo
rt
meas
ures
are
insuff
icient
to
contr
ol the
clinic
al
condi
tion.
3169. Co
ntrai
ndica
tions;
3170. Hy
perse
nsitiv
ity to
the
active
subst
ance
or to
3171.
3172. Hyper
sensitivit
y to the
active
substance
or to any
of the
excipient
s.
366
any
of the
excipi
ents.
Due
to the
prese
nce
of
sacch
arose,
Hidra
ec 30
mg is
contr
aindic
ated
in
patien
ts
with
fructo
se
intole
rance,
gluco
se
malab
sorpti
on
syndr
ome
and
sacch
araseisoma
ltose
defici
ency.
3173.
3174. The Registration Board in 248th meeting deferred the case
as firm has not mentioned complete facts regarding
indications, side effects, contra indications pointed out by
experts.
Thus
the
Board
advised
firm
to
update
367
aforementioned parameters in light of international approvals

for consideration of the Board. Now, the firm has updated the
aforementioned parameters and case is submitted for
consideration of the Board.
3175.
e. Foscan 1ml/Ml Solution For Injection 3ml Vial & 6ml Vial
3176.
3177.
3180.
3182.
Nam
3185.
3187.
3181.
3183.
Com
3184.
368
3189.
3194.
Fosca
3198.
3201.
3199.
3202.
3190.
3191.
3192.
3195.
Each
3193.
369
3196.
Temo
3197.
(Phot
3206.
3210.
Fosca
3214.
3217.
3215.
3218.
3207.
3208.
370
3209.
3211.
Each
3212.
Temo
3213.
(Phot
371
3221.
372
3222.
B
3227.
D
3232.
M
3223.
P
3228.
C
3233.
C
3224.
C
3229.
H
3234.
R
3225.
C
3230.
O
3235.
3226.
L
3231.
L
3236.
1
3242.
N
3237.
C
3243.
T
3238.
2
3244.
A
3245.
A
3239.
3
3240.
F
3241.
3246.
3247. 2nd reminder issued to Maj.Gen. Iftikhar Hussain (Advisor & HOD Oncology)
Combined Military Hospital, Rawalpindi Cantt on 29th April, 2015 but reply is still pending.
3249.
3250. Case No. 02. DISPOSED OF APPLICATIONS FIRM
ARE NOT INTERESTED.
a. M/s. Ferozsons Laboratories Limited, Nowshera
373
3251. The application submitted by M/s. Ferozsons Laboratories Limited, Nowshera

was sent to Pharmaceutical Evaluation Cell already on website at Serial No. 220. Upon the
instruction of legal manufacturer M/s. Gilead Sciences Inc. USA the firm has requested to
withdraw application for registration. They have requested to kindly terminate the registration
process of the under mentioned products.
1.
3253.
3254.
N
3255.
3256.
3264.
St
3273.
3265.
E
3274.
3266.
El
3257.
3267.
C
3268.
E
3269.
T
3270.
F
3258.
3271.
E
3272.
(
3259.
3260.
374
3261.
3262.
3263.
3275.
b. M/s. GlaxoSmithKline Pakistan Limited, Karachi
3277. The Drug Registration Board in its 243rd meeting held on 08-09th May, 2014
approved the under-mentioned drugs at Sr. No. 1 to 6 applied by M/s. GlaxoSmithKline Pakistan
375
Limited, Karachi manufactured by M/s. Onco Therapies Ltd, Bangalore, India subject to
inspection of manufacturer abroad as per policy. A panel was constituted for inspection (i) Dr.
Obaid Ali, Federal Inspector of Drugs, Drug Regulatory Authority of Pakistan, Karachi and (ii)
Mr. Ajmal Sohail Asif, Federal Inspector of Drugs, Drug Regulatory Authority of Pakistan,
Lahore.The constitution of panel for inspection of the aforesaid manufacturer is still under
process of approval. Meanwhile M/s. GlaxoSmithKline Pakistan Limited, Karachi has requested
to stop all registration related regulatory proceedings of these products and remaining two
products at Sr. No. 7-8 were sent to Pharmaceutical Evaluation Cell already on website at Serial
No. 111 & 112.
1.
3279.
Nam
3280.
N
3281.
3282.
M/s.
3284.
D
3288.
3285.
E
3289.
3286.
D
3290.
3291.
3287.
(
376
3283.
M/s.
2.
3292.
M/s.
3295.
D
3299.
3296.
E
3300.
3297.
1
3301.
3302.
3298.
(
377
3293.
M/s.
3294.
378
3.
3303.
M/s.
3305.
D
3309.
3306.
E
3310.
3307.
D
3311.
3312.
3308.
(
3304.
M/s.
379
4.
3313.
M/s.
3317.
D
3321.
3318.
E
3322.
3319.
1
3323.
3324.
3320.
(
3314.
M/s.
380
3315.
3316.
5.
3325.
M/s.
3327.
G
3331.
3328.
E
3332.
3329.
G
3333.
3330.
(
381
3326.
M/s.
6.
3334.
M/s.
3336.
G
3340.
3337.
E
3341.
3338.
G
3342.
3339.
(
382
3335.
M/s.
7.
3343.
M/s.
3345.
T
3349.
3346.
E
3350.
3347.
O
3348.
383
3344.
M/s.
384
8.
3351.
M/s.
3353.
T
3358.
3354.
E
3359.
3355.
O
3356.
(
3357.
3352.
M/s.
385
3360.
3362. Case No.3
3363.
Registration of Surgical Sutures.
Registration Board in its 243rd meeting held on 08-
09th May, 2014 approved the registration of following surgical

sutures in the name of M/s. Bajwa Sons, Lahoremanufactured
by M/s. Yancheng Huida Medical Instruments Co., Ltd.,
Chinasubject to inspection of manufacturer abroad:3364.
3365. Name
of
Products.
3367. Trugut
Chromic
Surgical
Suture
3369. Trucryl
(PGA)
Surgical
Suture
3371. Trulon
Nylon
Monofila
ment
Surgical
Suture
3373. TruSilk
Silk
Braided
386
Surgical
Suture
3374.
3375.
Inspection of the manufacturer M/s. Yancheng
Huida Medical Instruments Co., Ltd., Chinahas already been

carried out by the nominated panel comprising Mr.
Muhammad
Tanvir,
Director
(Administration),
Drug
Regulatory Authority of Pakistan, Islamabad and Mr. Abdul

Ghaffar, Deputy Drugs Controller (Pricing), Drug Regulatory
Authority of Pakistan, Islamabad.
3376.
The panel of inspectors has recommended the
registration of the above said products. The storage facility of

the importer has already been verified by the Area FID.
Drug Pricing Committee in its 12th meeting held on 03-022015 approved the price of the sutures.
3377.
3378.
3379. Case No.4
Name.
Change of Company Name, Manufacturing Facility & Product Trade

3380.
3381.
M/s. Popular International (Pvt.) Ltd., Karachi have
requested to approve the change of company name,

manufacturing facility & product
trade name of their
following registered imported surgical sutures as follows:3384.
3386.
3387.
387
3390.
3391.
3392.
3393.
3396.
3397.
3398.
3399.
3402.
3403.
3404.
3405.
3408.
3409.
3410.
3411.
3414.
3415.
3416.
3417.
388
3418.
3420.
3421.
3422.
3423.
3424.
3426.
3427.
3428.
3429.
3430.
3432.
3433.
3434.
3435.
3436.
3437.
The firm has deposited required fee and submitted
following supporting documents:3438. i)
Original Certificate to Foreign Government issued by FDA duly attested
from Embassy of Pakistan, Washington DC.
3439. ii)
EN ISO Certificates.
3440. iii)
EC Certificates.
3441. iv)
Copies of Registration letters.
3442.
3443.
M/s. Popular International (Pvt.) Ltd., Karachi was
advised to provide Form-5 (A), Site Master File and CoPP of

the above said products as both manufacturing site and license
holder has been changed.
3444.
M/s. Popular International (Pvt.) Ltd., Karachi has
submitted copies of CoPPs and Site Mister File. The firm has
further submitted that the only change is Principal Name from
389
Tyco to Covidien and no change in license holder the legal

manufacturer is Covidien llc, USA.
3445.
M/s. Popular International (Pvt.) Ltd., Karachi was
again advised to provide Form-5(A) complete with all

annexure of the above said products as both manufacturing
site and license holder has been changed.
3446.
In response, M/s. Popular International (Pvt.) Ltd.,
Karachi has submitted Form 5(A) along with annexure for

each product.
3447.
As the new manufacturing site is Dominican
Republic, M/s. Popular International (Pvt.) Ltd., Karachi was

advised to provide complete set of documents as per SOP.
3448.
In response, M/s. Popular International (Pvt.) Ltd.,
Karachi has submitted revised Form 5(A) along with annexure

for each product, plant master file and complete method of
testing.
3449.
Pharmaceutical Evaluation Cell evaluated the
applications and deficiencies were communicated to the firm.

The firm have removed the deficiencies and submitted the
information / document.
3450.
3451.
3452. Case No.05. Veterinary drugs deferred by Registration
Board for expert opinion.
a. Evaluated by Experts
3453. Registration Board in its 243rd meeting held on 08th -09th May, 2014 referred all
veterinary applications to a committed comprises of Dr. Muhammad Arshad, Member
Registration Board, Dr. Muhammad Ashraf, UVAS, Lahore and Head of Pharmacology
390
Department Arid University Rawalpindi for expert opinion. The recommendations of expert are
as under:3455. Name of
Importer/
3456. Manufacture
r.
1.
3461. M/s. Ghazi

Brothers,
3462. Karachi75350 /
3463. Product
License Holder:3464. M/s. Agrovet
Market S.A., San
Luis, Lima, Peru.
3465. Manufacture
r Under Product
License Holder:3466. M/s.
Pharmadix Corp.
S.A.C. Urbanizacion
La Aurora-Ate Lima
3-Peru.
3467.
3468.
3469.
3470.
3471.
3472.
3473.
3474.
3475.
3476.
3477.
2. 3488. M/s. Ghazi
Brothers,
3489. Karachi75350 /
3490. Product
3457. Name of Drug

(s)/Composition.
3458. Reco 3459. Recomm

mmendations endations of Dr.
of Dr.
Muhammad
Muhammad
Arshad,
Ashraf,
Member R.B
UVAS,
Lahore
3478. Metri-CEF 3
Intrauterine Suspension
3479. Each 30ml contains:3480. Cephalexin
monohydrate (Base)
.....600mg
3481. Neomycin sulfate
(Base)
1.02gm
3482. Cloxacillin
benzathine...1.50gm
3483. Vitamin
A.....30.000 IU
3484. Reco
mmended
3495. Catofos B9 + B12

Injectable Solution
3496. Each ml contains:3497. Butaphosphan
100mg
3501. Reco
mmended
3460. Rec
ommendati
ons of
Head of
Pharmacol
ogy
Departmen
t Arid
University
Rawalpindi
3485. He
3486. Dr.
endorsed
the Mazhar ul
recommendation Haq
s
of
Dr. 3487. Wr
Muhammad
ote to this
Ashraf.
office I
am unable
to put my
opinion on
said drugs
due
to
certain
unavoidabl
e reasons.
3502.
3503.
391
License Holder:3491. M/s. Agrovet

Market S.A., San
Luis, Lima, Peru.
3492. Manufacture
r Under Product
License Holder:3493. M/s.
Pharmadix Corp.
S.A.C. Urbanizacion
La Aurora-Ate Lima
3-Peru.
3498. Vitamin B9 (Folic

Acid)..15mg
3499. Vitamin B12
(Cyanocobalamin)
.0.05mg
3500. (Vitamin and
Mineral).
3494.
3508. Ketoxilen Injection
3509. Each 100ml
contains:3510. Oxytetracycline
...20gm
3511. Ketoprofen
3gm
3512. (Antibiotic/Antiinflammatory).
3513.
4. 3517. M/s. Ghazi
3520. Geslong Injection
Brothers,
3521. Each ml of solution
3518. Karachi. /
contains:3519. M/s. Cheilbio 3522. Metoclopramide
Co. Ltd., MoknaeHCI5mg
Dong, Ansan-Si,
3523. (Antiemetic/
Gyeonggi-Do, Korea. Gastroprokinetic).
3524.
5. 3528. M/s. Ghazi
3531. Cheil Tonocomp
Brothers,
Injection
3529. Karachi. /
3530. M/s. Cheilbio contains:Co. Ltd., Moknae3533. Toldimfos
Dong, Ansan-Si,
Gyeonggi-Do, Korea. sodium200mg
3.
6.
3504. M/s. Ghazi

Brothers,
3505. Karachi. /
3506. M/s. Vetanco
S.A. Buenos Aires,
Argentina.
3507.
3537. M/s. Ghazi

Brothers,
3538. Karachi. /
3539. M/s. Cheilbio
Co. Ltd., MoknaeDong, Ansan-Si,
Gyeonggi-Do, Korea.
3540. Seletoco Injection

contains:3542. Vitamin E
acetate..100mg
3543. Sodium
Selenite1mg
3544. (Nutritional
3514. Reco
mmended
3515.
3516.
3525. Reco
mmended
3526.
3527.
3534. Reco
mmended
3535.
3536.
3545. Reco
mmended
3546.
3547.
392
additive).
7.
3548. M/s. Ghazi

Brothers,
3549. Karachi. /
3550. M/s. Cheilbio
Co. Ltd., MoknaeDong, Ansan-Si,
Gyeonggi-Do, Korea.
3551. Procillin-LA
Injection
3559. Reco
mmended
3560.
3561.
3570. Potent
ial of misuse
on feed
additive &
drug
interaction.
3571.
3572.
3579. Potent
ial of misuse
on feed
additive &
drug
interaction.
3588. Reco
mmended
3580.
3581.
3589.
3590.
3598. Reco
mmended
3599.
3600.
3552. Each ml contains:3553. Pencillin G

3554. Benzathine
1,00,000 IU
3555. Penicillin G
Procaine1,00,000
IU
3556. Dihydrostreptomycin
sulfate200mg
3557. (Antibacterial).
3558.
8.
3562. M/s. Ghazi

Brothers, Karachi. /
3563. M/s. Cheilbio
Co. Ltd.GyeonggiDo, Korea.
3564.
9.
3573. M/s. Ghazi

3574. M/s. Cheilbio
Co. Ltd.GyeonggiDo, Korea.
10. 3582. M/s. Ghazi

3583. M/s. Hebei
Yuanzheng
Pharmaceutical Co.
Ltd., Shijiazhuang
City, Hebei Province,
China.
11. 3591. M/s. Ghazi
3592. M/s. Hebei
3565. Oxyneo Powder

3566. Each 1 Kg contains:3567. Oxytetracycline
Quaternary Ammonium
Salts110gm
3568. Neomycin
sulfate...110gm
3569. (Antibiotic).
3575. Oxyone Powder
3576. Each 1 Kg contains:3577. Oxytetracycline
Quaternary Ammonium
Salts.200g
3578. (Antibiotic).
3584. Cefquin Suspension
for Injection
3585. Each ml contains:3586. Cefquinome (as
sulfate)..25mg
3587. (Antibiotic).
3593. Isomedium Powder
for parental administration
3594. Each sachet
393
Yuanzheng
Pharmaceutical Co.
Ltd., Shijiazhuang
China.
12. 3601. M/s. Ghazi
3602. M/s. Hebei
Yuanzheng
Pharmaceutical Co.
Ltd., Shijiazhuang
China.
13. 3610. M/s. Ghazi
3611. M/s. Hebei
Yuanzheng
Pharmaceutical Co.
Ltd., Shijiazhuang
China.
14. 3619. M/s. Orient
Animal Health (Pvt)
Ltd., Karachi. /
3620. M/s. Univet
Ireland Ltd. Tullyvin,
Cootehill, Co. Cavan,
Ireland.
15. 3628. M/s. Orient
Animal Health (Pvt)
Ltd., Karachi. /
3629. M/s. Univet
Ireland.
3630.
16. 3639. M/s. Orient
Animal Health (Pvt)
Ltd., Karachi. /
3640. M/s. Univet
Ireland.
3641.
contains:3595. Isometamedium
chloride
hydrochloride..
1g
3596. (Antiprotozoal).
3597.
3603. Oxybiotic LA 30%
Solution for Injection
3604. Each ml contains:3605. Oxytetracycline (as
dihydrate)
.300mg
3606. (Antibiotic).
3612. Bupaquone Solution
for Injection
3613. Each ml contains:3614. Buparvaqone
...50mg
3615. (Antiprotozoal).
3607. Reco
mmended
3608.
3609.
3616. Reco
mmended
3617.
3618.
3621. Unimox LA Injection

3622. Each ml contains:3623. Amoxicillin (as
Amoxicillin Trihydrate) Ph.
Eur...150mg
3625. 3626.
3627. -
3631. Unicycline LA
Injection
3632. Each ml contains:3633. Oxytetracycline (as
Oxytetracycline Dihydrate
Ph. Eur)
...200mg
3642. Multivit Injection
3643. Each 1 ml contains:3644. Vitamin
B1.10mg
3645. Vitamin B2...
5mg
3646. Vitamin B6.
..3mg
3635.
3636.
3654.
3655.
394
3637.
3656.
17. 3657. M/s. Orient

Animal Health (Pvt)
Ltd. Karachi. /
3658. M/s. V.M.D.
N.V, Hoge Mauw,
Arendonk-Belgium.
18. 3667. M/s. Orient

Animal Health (Pvt)
Ltd., Karachi. /
3668. M/s. V.M.D.
N.V, Hoge Mauw,
Arendonk-Belgium.
19. 3677. M/s. Marush
(Pvt) Ltd.,
3678. Lahore. /
3679. M/s. Univet
Ltd. Tullyvin,
Ireland.
20. 3690. M/s. U.M.

Enterprises,
3647. Vitamin
B12....0.05mg
3648. Nicotinamide
..35mg
3649. D-Panthenol.
...25mg
3650. Vitamin A
15,000 IU
3651. Vitamin
D3....1,000 IU
3652. Vitamin
E........10mg
3653. (Multivitamins).
3659. Promycin-1000
Injectable Solution
3660. Each ml contains:3661. Colistin
Sulphate..1,000,000
IU
3662. (Polypeptide
Antibiotic).
3663.
3669. Promycin-4800
Water Soluble Powder
3670. Each gram contains:3671. Colistin Sulphate
4,800,000 IU
3672. (Polypeptide
Antibiotic).
3673.
3680. Ubroloxin
Intramammary Suspension
3681. Each 1 injector with
10g (12ml) contains:3682. Cefalexin
monohydrate...................200
mg
3683. Kanamycin
monosulfate
133mg
3684. (Corresponds to
100,000 I.U).
3685. (Pharmaceuticals).
3686.
3694. Flumeglu 5gm
Injection
3664.
3665.
3666.
3674.
3675.
3676.
3687.
3688.
3699.
3700.
395
3691.
Kar
achi-74900/
3692. M/s. Qilu
Animal Health
Products Co. Ltd.,
Jinan, Shandong,
China.
3693.
21. 3702. M/s. U.M.
Enterprises,
3703.
Kar
achi-74900/
3704. M/s. Qilu
Animal Health
Products Co. Ltd.,
Jinan, Shandong,
China.
22. 3712. M/s. U.M.
Enterprises, Karachi74900/
3713. M/s. Qilu
Animal Health
Products Co. Ltd.,
Jinan, Shandong,
China.
23. 3722. M/s. U.M.
Enterprises,
3723.
Kar
achi-74900/
3724. M/s. Qilu
Animal Health
Products Co. Ltd.,
Jinan, Shandong,
China.
24. 3733. M/s. Siddiqui
Pharma (Pvt) Ltd.,
Multan. /
3734. M/s. KBNP,
INC, Dugok-ri,
Sinam, Yesan,
Chungnam, Korea.
3735.
Pharma (Pvt) Ltd.,
Multan. /
3695. Each 100ml

contains:3696. Flunixin Meglumine
equivalent to 5.0g of
Flunixin.
3697. (Non-steriod, Antinflammatory drug).
3698.
3705. Cefent 1gm Injection
3706. Each 25ml vial
contains:3707. Ceftiofur Sodium
equivalent to 1.0g Ceftiofur.
3708. (B.Lactum
Antibiotics).
3714. Cefent 4gm Injection
contains:3716. Ceftiofur Sodium
equivalent to 4.0g Ceftiofur.
3717. (B.Lactum
Antibiotics).
3718.
3725. Ceftihyde 5gm
Injection
3726. Each 100ml
contains:3727. Ceftiofur
Hydrochloride equivalent to
5.0g Ceftiofur.
3728. (B.Lactum
Antibiotics).
3729.
3736. Ciroxin 10% Oral
Solution
3737. Each Liter contains:3738. Ciprofloxacin
100g
3739. (Antibiotics).
3740.
3747. Kenoxin 10% Oral
Solution
3748. Each Liter contains:-
3751. Reco
mmended
3709.
3710.
3719.
3720.
3730.
3731.
3741.
3742.
3752.
396
3745. M/s. KBNP,

INC, Dugok-ri,
Sinam, Yesan,
Chungnam, Korea.
3746.
Pharma (Pvt) Ltd.,
Multan. /
3755. M/s. KBNP,
INC, Dugok-ri,
Sinam, Yesan,
Chungnam, Korea.
27. 3763. M/s. Mustafa
Brothers Faisalabad. /
3764. M/s.
Laboratorio Centrovet
Santiago, Chile.
3749. Enrofloxacin
100g
3756. Noroxin 200 Oral
Solution
3757. Each Liter contains:3758. Norfloxacin
200g
3760. Reco
mmended
3761.
3765. Cefalexine Injectable

Suspension 15%
3769. Reco
mmended
3770.
3783. Reco
mmended
3784.
3805. More
chances of
their misuse,
drug
interaction
and
development
of resistance.
It is better to
3806.
3766. Each 10ml contains:

3767. Cefalexine .150/ml
3768. (Beta lactam
Antibiotic)
28. 3772. M/s. Mustafa

3774. Ceftiofur
Brothers Faisalabad. / Hydrochloride Injectable
3773. M/s.
Suspension 5%
Laboratorio Centrovet 3775. Contains:
Santiago, Chile.
3776. Ceftiofur
Hydrochloride...50
mg
3777. (Antibiotic)
3778.
3779.
3780.
3781.
3782.
29. 3786. M/s. Ghazi
Brothers,
3787. Karachi. /
3788. M/s.
CEVASA S.A.
Buenos Aires,
Argentina.
3789.
3790. Sulfyvit Water

Soluble Powder
3791. Each 100gm
contains:3792. Sodium
sulfaquinoxaline..15g
m
3793. Sodium
sulfamethazine.14
397
30. 3808. M/s. Fartal

Pharmaceuticals,
3809. Karachi. /
3810. M/s.
Laboratorios
Microsules Uruguay
S.A. Canelones,
Uruguay.
gm
3794. Sodium
sulfadimethoxine...2g
m
3795. Trimethoprim
...6gm
3796. Prednisolone.
..0.004gm
3797. Vitamin A....
300,000IU
3798. Vitamin
E..200 IU
3799. Vitamin D3..
..60.000IU
3800. Vitamin
C.2gm
3801. Vitamin
K3..1gm
3802. Excipients..
..q.s
3803. (Antibiotic, steroids
Vitamin).
3804.
3811. Ivermic M.O.
Injectable Suspension
3812. Each ml contains:3813. Ivermectin..
1,000g
3814. Zinc Sulphate
7H20...0,043g
3815. Magnesum Chloride
6H20...0,65
0g
3816. Copper Chloride
2H20...0,00
4g
3817. Magnesium
Hypophosphite
6H20..2,67
0g
3818. Potassium
Iodide...0.030g
3819. Vitamin
B12..0,010g
3820. Histidine
HCI0,420g
have separate
products for
specific
purpose.
Need
experimental
verification
for such
combination,
3827. More
chances
of
their misuse,
drug
interaction
and
development
of resistance.
It is better to
have separate
products for
specific
purpose.
3828.
398
31. 3830. M/s.

International
Chempharma
(Pakistan) Lahore. /
3831. M/s.
Biopharmachemie Co
Ltd TangNhon Phu
Vietnam.
3821. Valine.
..0,420g
3822. Arginine
HCI.0,510g
3823. Methionine
0,420g
3824. Threonine
..0,500g
3825. Sodium monobasic
glutamate....0,84
0g
3826. (Endectocide,
organic
3832. CTC Plus Water
Soluble Powder
3833. Contains:3834. Chlortetracycline
5500mg
3835. Vitamin
A2400IU
3836. Potassium
Chloride..760mg
3837. Vitamin
B12...280mcg
3840. More
chances of
their misuse,
drug
interaction
and
development
of resistance.
It is better to
have separate
products for
specific
purpose.
3841.
3850. Reco
mmended
3851.
3874. More
chances of
their misuse,
drug
interaction
and
development
of resistance.
It is better to
3875.
3838. Lysine
60mg
3839. (Antibiotic)
32. 3843. M/s. Better
Traders International,
3844. Faisalabad. /
3845. M/s. Kepro
B.V.
Maagdenburgstraat,
Holland.
33. 3853. M/s. Ani Cure
Veterinary Services,
Rawalpindi. /
3854. M/s.
Interchemie Werken
De Adelaar B.V.
Metaalweg, CG
Venray, Holland.
3855.
3846. Thiacol 10% Oral

Solution
3847. Each ml contains:3848. Thiamphenicol
.100mg
3849. (Broad Spectrum
Antimicrobial Agent).
3856. Nemovit Water
Soluble Powder
3857. Each gm contains: 3858. Neomycin
Sulpahte..
40mg
3859. Oxytetracycline
399
HCl...60mg
3860. Vitamin
A7500IU
3861. Vitamin D3,
Cholecalciferol..1500
IU
have separate
products for
specific
purpose.
3862. Vitamin E, atocopherol

acetate....5
mg
3863. Vitamin
B1.thiamine
hydrochloride.....
1mg
3864. Vitamin B2,
riboflavine.
.....2mg
3865. Vitamin B6,
pyridoxine
hydrochloride.....2
mg
3866. Vitamin B12,
cyanocobalamin.....7.
5
3867. Vitamin C, Ascorbic
acid..25mg
3868. Capantothenate.7.5mg
3869. Vitamin K3,
menadione sodium
bisulfite.5mg
3870. Nicotinamide
.5mg
3871. Folic
Acid..300g
3872. DLMethionine30mg
3873. L-Lysine
hydrochloride...50
mg
400
34. 3877. M/s. Ani Cure

Veterinary Services,
Rawalpindi. /
3878. M/s.
Interchemie Werken
De Adelaar B.V.
Metaalweg, CG
Venray, Holland.
3879.
3880. Aliseryl Water

Soluble Powder
3881. Each gm contains: 3882. Erythromycin
thiocyanate..
35mg
3883. Oxytetracycline
HCl...50mg
3884. Streptomycin
Sulphate35mg
3885. Colistin
Sulphate.
..200,000IU
3898. More
chances of
their misuse,
drug
interaction
and
development
of resistance.
It is better to
have separate
products for
specific
purpose.
3899.
3886. Vitamin A, retinol

acetate
3000IU
3887. Vitamin D3,
cholecalciferol
1500IU
3888. Vitamin E, atocopherol acetate.
..2mg
3889. Vitamin B1, thiamine
hydrochloride.2
mg
3890. Vitamin B2,
riboflavine..4mg
3891. Vitamin B6,
pyridoxine
hydrochloride.2
mg
3892. Vitamin B12,
cyanocobalamin..10
g
3893. Vitamin C, Ascorbic
Acid..20mg
3894. Capantothenate10mg
3895. Vitamin K3,
menadione sodium
401
bisulfite..2
mg
3896. Nicotinamide
...20mg
3897. Inositol
..1mg
35. 3901. M/s. Seignior
Pharma
3902. Karachi./
3903. M/s. Instituto
Rosenbusch S.A. de
Biologia
Experimental
Agropecuaria, San
Jose 1469 (1136)
Buenos Aires,
Argentina.
3904.
3905.
36. 3915. M/s. Seignior
Pharma, Karachi. /
3916. M/s. Instituto
Rosenbusch S.A. de
Biologia
Experimental
Agropecuaria, San
Jose 1469 (1136)
Buenos Aires,
Argentina.
3917.
37. 3927. M/s. Bio-Labs
(Pvt) Ltd., Islamabad.
3906. Ceftiofur LPU

Injectable
contains: 3908. Ceftiofur
HCL50mg
3909. Excipients.
.100ml
3910. (Antibiotic)
3911.
3912. Reco
mmended
3913.
3918. Florfenicol 30%

Rosenbusch Injectable
contains:3920. Florfenicol...
...30gm
3921. Excipients q.s....
100ml
3922. (Antibiotic)
3923.
3924. Reco
mmended
3925.
3928. Bio-Enrocol-A
Liquid
3929. Each 100ml
contains:3930. Enrofloxacin.
....10%
3931. Colistin
Sulphate..3.5%
3932. Amantadine
.....4%
3933. (Antibiotic, Antiviral).
3934.
3935.
3936. Contai
ns
Amantadine
which
is
antiviral drug
for flu and
may
have
drug
interaction
and resistance
problem
so
should not be
used in these
combinations.
3937.
3940.
402
38. 3942. M/s. Bio-Labs

(Pvt) Ltd., Islamabad.
39. 3953. M/s. Leads

Pharma (Pvt) Ltd.,
Islamabad.
40. 3965. M/s. Elko

Organization (Pvt)
Ltd., Karachi.
3943. Coliflox 20% Liquid

3944. Each 100ml
contains:3945. Enrofloxacin
20gm
3946. Colistin Sulphate
50,000,000 i.u.
3947. (Quinolones).
3948.
3949.
3954. Virex CRD Powder
3955. Contains:3956. Tylosin
Tartrate.....10%
3957. Doxycycline
HCI...22%
3958. Colistin
Sulphate.4%
3959. Amantadine
HCI.3%
3960. (Antibiotic).
3966. Fe-Zole SC 5% Oral

Suspension
3967. Each ml contains:3968. Fenbendazole
...50mg
3969. Elemental
Selenium....1.6mg
3970. Elemental
Cobalt.............10mg
3971. (Anthelmintic).
3972.
41. 3976. Noble Pharma 3977. ENTRO-5 Powder
Mirpur Azad
3978. Each 1000gm
Kashmir.
contains:3979. Tylosin Tartrate
BP..10%
3980. Doxycycline Hyclate
USP20%
3981. Colistin
3938.
3939.
3950. Reco
mmended
3951.
3961. Contai
ns
Amantadine
which is
antiviral drug
for flu and
may have
drug
interaction
and resistance
problem so
should not be
used in these
combinations.
3962.
3963.
3973.
3987.
3974.
3988.
403
42. 3990. M/s. Mallard

Ltd., Multan.
3991.
43. 4004. M/s. Intervac

(Pvt) Ltd,
Sheikhupura Road,
Sheikhpura.
4005.
44. 4015. M/s. Intervac

(Pvt) Limited,
Lahore.
45. 4026. M/s. Attabak

4027. Pharmaceutic
al,
4028. Islamabad.
Sulphate...450 MIU
3982. Bromhexine
HCI0.5%
3983. Neomycin
SO43.6%
3985.
3986.
3992. Centrum Liquid
3993. Each 100ml
HCI...7500mg
3995. Sulphamethoxypyrid
azine
7500mg
3996. Sulphamethazine
5000mg
3997. Trimethoprim
2500mg
3998. (Antibiotic).
3999.
4000.
4006. Tilmodox Liquid
4007. Each 100ml
contains:4008. Tilmicosin
Phosphate.15gm
4009. Doxycycline
HCI15gm
4010. (Antibiotic).
4011.
4016. Amprobit Liquid
4017. Each liter contains:4018. Amprolium
HCI250gm
4019. Ethopabate
..16gm
4020. (Anticoccidial).
4021.
4022.
4029. Tylothrodox Powder
4030. Each 1000gm
contains:4031. Doxycycline
HCl..100g
4002.
4012.
4023.
4036.
4013.
4024.
4037.
404
4032. Tylosin tartrate

..50g
4033. Amantadine HCl
...40g
4034. Erythromycin
thiocyanate..60g
4035. (Antibacterial,
Antiviral).
46. 4039. M/s. Attabak

4040. Pharmaceutic
al,
4041. Islamabad.
47. 4055. M/s. DMaarson

4056. Pharmaceutic
als, Rawat,
Islamabad.
4042. Spiralinc-B Powder

4043. Each 100gm powder
contains:4044. Lincomycin
HCI..5g
4045. Spectinomycin
HCI..7.5g
4046. Spiramycin
adipate...........2.5g
4047. Bromhexine
HCI...0.5g
4048. (Antibacterials).
4049.
4050.
4051.
4057. CRD-555 Water
Soluble Powder
4058. Each 1000g
contains:4059. Doxycycline
HCl ............200g
4060. Tylosin tartrate
....100g
4061. Colistin
sulphate500MIU
4062. Amantadine HCl
..40g
4063.
4064.
4065.
4066.
4067.
4068.
4069.
4052.
4070.
4053.
4071.
405
48. 4073. M/s. Symans

Ltd. Lahore.
4074.
49. 4085. M/s. Symans

Ltd. Lahore.
4086.
50. 4096. M/s. Jfrin

Pharmaceutical
Laboratories, Hub,
Balochistan.
4075. SPZ-Plus Feed

Additive Oral
4076. Each 100gm
contains:4077. Procaine Penicillin
B.P1200mg
4078. Streptomycine
Sulphate
B.P
3600mg
4079. Zinc Bacitracin
B.P5200mg
B.P.500 MIU
4081. (Antimicobial).
4087. Cipro Plus Solution
4088. Each Liter Contains:4089. Ciprofloxacin
200gm
4090. Colistin
Sulphate400MIU
4091. Amantadine
.40gm
4097. Jfpidox Oral Powder

4098. Each Kg contains:4099. Tylosin
Tartrate100gm
4100. Doxycycline
Hcl...200gm
4101. Phyenylbutazone.
12gm
4102. Bromhexine
Hcl...........5gm
4103. Colistine
Sulphate.500 MIU
4104. (Antibacterial/Antibi
otic).
4082.
4083.
4093.
4094.
4105.
4106.
406
51. 4108. M/s. Biogen

Pharma. 8th Km
Rawat Chak Beli
Road, Rawat.
4109. Amcocin Liquid

4110. Each 100ml
.10%
4112. Colistin
Sulphate3%
4113. Amantadine
HCI4%
4114. (Antibiotic)
52. 4119. M/s. Biogen

Pharma. 8th Km
Rawat Chak Beli
Road, Rawat.
4120. Doxytylodine
Powder
4121. Each 1000gm
contains:4122. Tylosin Tartrate
BP..200gm
4123. Doxycycline HCI
BP100gm
4124. Amantadine
HCI.40gm
53. 4128. M/s. Biogen

Pharma, Rawat.
4129. Advantage Water

Soluble Powder
4130. Each 1000gm
contains:4131. Tylosin Tartrate BP..
200gm
4132. Doxycycline HCI
BP.40gm
4133. Amantadine
HCI...100gm
4115.
4117.
4116.
4125.
4126.
4137. Contai 4139.

ns
Amantadine
which is
antiviral drug
for flu and
may have
drug
interaction
and resistance
problem so
4140.
407
4127.
5000 MIU
4135.
4136. (Antibiotic/
Antibacterial/Antiviral).
54. 4141. M/s. Wimits
4143. Wimtox Injection
Pharmaceuticals,
4144. Each ml of liquid
4142. Plot No.129,
injection contains:Sunder Industrial
4145. Novaminsulfon
Estate (P.I.E) Raiwind ....40mg
Road, Lahore.
4146. Etilefrin B.P
...0.2mg
4147. Calcium Gluconate
B.P.100mg
4148. Magnesium
Gluconate
4149. B.P
.10mg
4150. Sodium Salicylate
B.P 7mg
4151. Nicotinamide B.P
.0.3mg
4152. Caffeine B.P
..10mg
4153. Boric Acid B.P
..10mg
4154.
4155. (Analgesic and
Antipyretic)
4156. Finished product
specifications are
Manufacturer.
55. 4160. M/s. Wimits
4162. Stop Spray
Pharmaceuticals,
4163. Each 100ml of
4161. Plot No.129,
aerosol contains:Sunder Industrial
4164. Deltamethrin
Estate (P.I.E) Raiwind BP...0.500g
Road, Lahore.
4165.
4166. (Insecticide)
56. 4170. M/s. Wimits
4172. Defender Spray
Pharmaceuticals,
4173. Each 30g of aerosol
4171. Plot No.129,
contains:Sunder Industrial
4174. Neomycin Sulfate
Estate (P.I.E) Raiwind BP...150mg
Road, Lahore.
4175. Clostebol
Acetate.....150 mg
should not be
used in these
combinations.
4138.
4157.
4158.
4159.
4167.
4168.
4169.
4177.
4178.
4179.
408
4176. (Antiseptic)
57. 4180. M/s. Wimits
4182. Methra Spray
Pharmaceuticals,
4183. Each 100ml of
4181. Plot No.129,
aerosol contains:Sunder Industrial
4184. Permethrin
Estate (P.I.E) Raiwind ..0.5 g
Road, Lahore.
4185.
4186. (Insecticide)
4187.
4188.
4189.
4190.
58. 4194. M/s. D4196. NOVA
DM
Maarson
INJECTION
Pharmaceuticals,
4197. Liquid Injection
4195. Plot # 17,
4198. Each
100ml
Street # SS-2,
contains:National Industrial
4199. Novaminsulfon
Zone Rawat,
....4g
Islamabad.
4200. Etilefrin
...0.02g
4201. Calcium
Gluconate10g
4202. Magnesium
Gluconate...1.0g
4203. Sodium
salicylate..0.700g
4204. Nicotinamide
....0.3g
4205. Caffeine
.1.0g
4206. Boric
acid..1.0g
4207. (Analgesic,
Antipyretic)
4211.
4212. Case No.06
Registration
of
4191.
4192.
4193.
4208.
4209.
4210.
Imported
Veterinary
Drugs.
4213.
Drug Registration Board in its 237th meeting held
on 26-02-2013 approved the registration of following

imported veterinary drugs in the name of M/s. Pantex
Pharmaceutica, 26-Abbot Road, Lahore, manufactured by
409
M/s. Pantex Holland B.V. Duizel, Holland, subject to

inspection of manufacturer abroad, verification of storage
facilities as per policy:4215. Name of Drug (s) /
Composition.
4217.
4219.
P
4223.
4224.
4225.
4227.
4233.
4234.
4235.
4236.
4237.
4220.
E
4221.
E
4222.
4229.
P
4230.
E
4231.
D
4232.
T
4238.
4239.
The firm has deposited fee Rs.100000x2=200000/-.
The storage facility of the importer has also verified by the

Area FID.
4240.
The applicant M/s. Pantex
Pharmaceutica, 26-
Abbot Road, Lahore has requested for issuance of registration

letter of the above said drugs as they are importing the
products from Holland which is exempted from inspection of
manufacturer abroad as per new import policy.
410
4241.
As the drugs are not on free sale in country of origin
and it is also pertinent to mention here that the GMP

Certificate issued by Dutch authority for M/s. Pantex Holland
B.V., Holland indicate the firm is only authorized for Batch
Certification and not a manufacturer of dosage form. The
CoPP indicate it is a manufacturer of dosage form. Therefore,
M/s. Pantex Pharmaceutica, Lahore was advised to clarify the
same.
4242.
In response, M/s. Pantex Pharmaceutica, Lahore
have submitted a reply from their principal abroad M/s.

Pantex Holland BV which is self explanatory.
4243.
As the drugs are not on free sale in country of origin
and it is also pertinent to mention here that the GMP

Certificate issued by Dutch authority for M/s. Pantex Holland
B.V., Holland indicate the firm is only authorized for Batch
Certification and not a manufacturer of dosage form. The
CoPP indicate it is a manufacturer of dosage form.
4244.
Therefore, M/s. Pantex Pharmaceutica, Lahore was
again advised to clarify the same.

4245.
In response, M/s. Pantex Pharmaceutica, Lahore
have submitted a reply of their principals M/s. Pantex Holland

BV which is self explanatory.
4246.
Now, the firm M/s. Pantex Pharmaceutica, Lahore
informed that the products referred above are being

manufactured by M/s. Produlab Pharma BV, Holland and M/s.
Laboratoires Biove, France respectively under the supervision
of their technical staff.
4247.
This is a new development and against the dossier
of the products which mentioned M/s. Pantex Holland B.V.,

411
Holland as manufacturer. Therefore, it is proposed we may

advise to the firm to submit new dossier as per current
information i.e. Pantex is not the manufacturer or rather it is
marketer or toll manufacturer holder firm manufacturer
mentioned as above.
4248.
4249.
4250. Case No.07
Cancellation of Products of Rotexmedica.

4251.
M/s. Genepharm S.A., Greece hereby declares that
their following products have been registered under the name

of M/s. Rotexmedica Pakistan Pvt. Ltd., Islamabad, without
any agreement and / or authorization by their company:-
4255.
4256.
4261.
4262.
4254. Na
me of
Prod
ucts.
4257. El
bat
Tablet
s
250m
g.
4258. Ea
ch
tablet
contai
ns:4259. Flu
tamid
e
..2
50mg
.
4260.
4263. Ci
azil
Inject
ion
412
4267.
4268.
4273.
4274.
10mg
.
4264. Ea
ch
5ml
vial
contai
ns: 4265. Ep
irubic
in (as
HCI)
.10
mg.
4266.
4269. Fin
astir
Tablet
.
4270. Ea
ch
film
coate
d
tablet
contai
ns:4271. Fin
asteri
de
.
.5mg.
4272.
4275. Ci
azil
Inject
ion
50mg
.
4276. Ea
ch
25via
l
contai
ns: 4277. Ep
413
4279.
4280.
4286.
irubic
in (as
HCI)
.50
mg.
4278.
4281. Do
xotil
Inject
ion
10mg
.
4282. Ea
ch
5ml
vial
contai
ns: 4283. Do
xorub
icin
HCI
(USP
)
10mg
.
4284.
4287. Do
xotil
Inject
ion
50mg
.
4288. Ea
ch
25ml
vial
contai
ns: 4289. Do
xorub
icin
HCI
(USP
)
50mg
414
4292.
4298.
.
4290.
4293. Ge
nefad
rone
Inject
ion
20mg
.
4294. Ea
ch
10ml
vial
contai
ns: 4295. Mi
toxan
trone
(as
HCl)
.20
mg.
4296.
4299. Ge
neple
x
1mg
Tablet
s.
4300. Ea
ch
tablet
s
contai
ns:4301. An
astroz
ole
..1
mg.
4302.
4303.
4304.
M/s. Genepharm S.A., Greece have requested to
cancel the registration and transfer the above mentioned

415
products in the name of M/s. Umar Pharma, Peshawar, which

is their exclusive distributor for Pakistan, according to their
distribution agreement dated 10-04-2013.
4305.
Accordingly, M/s. Rotexmedica Pakistan Pvt. Ltd.,
Islamabad was issued a Show Cause Notice under section 7

(11) (a) of the Drugs Act, 1976 and required to explain their
position in writing within 15 days of issue of this notice, as to
why registration of the above said drugs registered in their
name may not be cancelled. Failing which it will be presumed
that you have nothing to offer in your defense and an ex-party
decision would be took against them in the Registration
Board.
4306.
M/s. Rotexmedica Pakistan Pvt. Ltd., Islamabad and
M/s. Haji Medicine Co., Rawalpind was also called for

personal hearing in its 248th meeting held on 18-19th March,
2015. Board decided to issue final notice for personal hearing
in forthcoming meeting.
4307.
Reply of the firms have been received, which is self
explanatory, please.
4308.
4309.
4310. Case No.08
Cancellation of Exclusive Distributorship Agreement.

4311.
The manufacturer M/s. Genepharm S.A., Greece
has informed that they would not precede to renewal /

extension of term of agreement and they also abstained
distributor
from
using
marketing
authorizations
after
termination with M/s. Haji Medicine Co., Rawalpindi.
416
4312.
The distributor M/s. Haji Medicine Co., Rawalpindi
requested not to revoke, suspend or transfer the registration of

following drugs until sale of drugs is in their possession:4313.
4314.
4315.
4318.
4325.
4332.
4338.
4316. Name of
drug (s) &
Composition.
4319. Zymoplex
10mg Tablets.
4320. Each tablet
contains:4321. Tamoxifen
Citrate
15.2mg
4322. eq to
Tamoxifen
10mg.
4323.
4326. Zymoplex
20mg Tablets.
4327. Each tablet
contains: 4328. Tamoxifen
Citrate
30.4mg
4329. eq to
Tamoxifen.
20mg.
4330.
4333. Bicamide
Tablets.
4334. Each film
coated tablet
contains: 4335. Bicalutami
de .50mg.
4336.
4339. Bicamide
Tablets.
4340. Each film
coated tablet
contains: 4341. Bicalutami
417
4344.
de .150mg.
4342.
4345. Femaplex
Tablets.
4346. Each tablet
contains: 4347. Letrozole
2.5mg.
4348.
4349.
Distributorship Agreement is effective from 25-03-
2008 and will be effective for five years up to 25-03-2013

unless sooner terminated by either party.
4350.
According to article 21 of agreement, on expiration
of agreement, distributor shall immediately cease and refrain

from sale, promotion, offering, forwarding and shipping of the
products and distributor also grants full authority to M/s.
Genepharm S.A., Greece to carryout the transfer of any and
all mentioned import permits, health and governmental
authorizations, registration and / or applications with respect
to products to the name of M/s. Genepharm S.A., Greece or to
its nominee, if otherwise registered, upon expiration or
termination of this agreement.
4351.
The case was placed before the Registration Board
in its 237th meeting and decided for the personal hearing of the
firm.
4352.
Registration Board in its 248th meeting held on 18-
19th March, 2015 decided to issue final notice for personal

hearing in forthcoming meeting.
4353.
4354.
418
4355. Case No.09
Source Transfer of Isotrex Gel (Reg.
No.015717).
4356. M/s. GlaxoSmithKline Pakistan Limited, Karachi have
requested to approve the change of source of manufacturing &
supply of their registered imported drug Isotrex Gel
(Isotretinoin 0.05%) (Reg. No.015717) from M/s. Stiefel
Laboratories Pte Ltd., Singapore to M/s. Glaxo Operations
UK Limited, Barnard Castle, UK.
4357.
The firm has deposited required fee and submitted
supporting documents.
Case was referred to Incharge,
Pharmaceutical Evaluation Cell for evaluation. Evaluation

Cell evaluates the application.
4358.
4359.
4360. Case No.10. Termination of Agreement.
4361.
M/s.
Genome
Pharmaceuticals
(Pvt)
Ltd.,
Rawalpindi have requested for transfer of registration of the

following registered imported blood bags from the name of
previous agent M/s. 3H Hoffmann Human Health Pakistan
Ltd., Lahore to their name as the manufacturer abroad M/s.
Shandong Weigao Group Medical Polymer Co. Ltd., China
has terminated the agency agreement of the previous agent
and appointed them as new agent in Pakistan for these
products:4362.
4363.
4364. Name of
Products
4366.
4367. Single
Disposable Blood
Bag
(CPDA
Solution)
with
419
Transfusion Set.
4369.
4370. Double
Disposable Blood
Bag
(CPDA
Solution)
with
Transfusion Set.
4372.
4373. Triple
Disposable Blood
Bag
(CPDA
Solution)
with
Transfusion Set.
4374.
4375.
The applicant M/s. Genome Pharmaceuticals (Pvt)
Ltd., Rawalpindi have deposited fee Rs.50000x3=150000/and submitted following supporting documents:4376. i)
Termination of Agreement of Previous Agent.
4377. ii)
Authorization of New Sole Distribution of the New Agent

4378.
4379.
M/s.
Genome
Pharmaceuticals
(Pvt)
Ltd.,
Rawalpindi was advised to provide NOC of the former agent

M/s. 3H Hoffmann Human Health Pakistan Limited, Lahore
regarding transfer of registration of the above said products. In
response,
M/s.
Genome
Pharmaceuticals
(Pvt)
Ltd.,
Rawalpindi have not provided NOC of the former agent.

4380.
The previous agent M/s. 3H Hoffmann Human
Health Pakistan Ltd., Lahore was advised to clarify that as the

manufacturer abroad M/s. Shandong Weigao Group Medical
Polymer Co. Ltd., China has terminated the agency agreement
with you for the products.
420
4381.
In response, M/s. 3H Hoffmann Human Health
Pakistan Ltd., Lahore intimated that they have serious

reservation on the decision by the M/s. Shandong Weigao
Group Medical Polymer Co. Ltd., China. The matter
Termination of Agreement is under discussion with M/s.
Shandong Weigao Group Medical Polymer Co. Ltd., China
and it is hoped that the matter will be resolved very soon and
business relation will be continued further after getting
satisfactory response from M/s. Shandong Weigao Group
Medical Polymer Co. Ltd., China. Therefore they have
requested to wait for further processing in the matter and
oblige.
4382.
The case was placed before the Registration Board
and it was decided to call the firm M/s. 3H Hoffmann Health

Pakistan Ltd., Lahore for personal hearing.
4383.
Col. (R) J Zahoor CEO of M/s. 3H Hoffmann
Human Health Pakistan Ltd., Lahore appeared before

Registration Board and informed they discontinued the import
of blood bags from M/s. Shandong Weigao Group Medical
Polymer Co. Ltd., China as firm received complaints from
different institutions about quality of these blood bags.
Resultantly manufacturer is now changing their local agent.
4384.
The Board took serious notice of matter and decided
that the case should be thoroughly investigated by the area

FID Lahore and report be placed in forthcoming meeting for
decision.
4385.
Accordingly, Deputy Director General (E&M),
Lahore was requested to investigate the matter through the

area FID and submit its report within the one week for
421
placement the case in the Drug Registration Board in its next

meeting.
4386.
In response, Deputy Director General (E&M),
Lahore have submitted the copies of the three complaints

received from the following hospitals:4387.
i)
Lady Aitcheson Hospital, Lahore.
4388.
ii)
DHQ Hospital, Mardan.
4389.
iii)
Peshawar.
Institute of Kidney Disease, Hayatabad,
4390.
4391.
As per details, 162000 Bags had been imported
from the foreign principals whereas last shipment was

received in July, 2009.
4392.
The foreign principal need to be approached /
inspected for its stance & verification of cGMP conformance,

for further investigation.
4393.
Federal Inspector of Drugs, Lahore was again
advised to submit detail investigation report in the light of

data submitted by the firm along with verification by office
record of Assistant Drugs Controller Clearance and action
taken by the firm on complaints received by different
purchasing authorities for consideration of Registration Board.
4394.
In response, Federal Inspector of Drugs, Lahore
informed that the office record have been checked for import
of above said items and it was found that firm had imported
consignments from Shandong Weigao, China, from 2007 to
2009. After 2009 no clearance has been granted as per their
available record. The firm M/s. Hoffmann Human Health
422
Pakistan could provide the incidents pertaining to Quality

Issues, relating to their imported blood bags.
4395.
The Chief Executive Officer of M/s. Hoffmann
Human Health Pakistan, Col. (Retd) Javaid Zahoor was

contacted for further action, if any, initiated by them with their
foreign principle for quality issues reported to them by the
purchasers. He informed on telephone that correspondence
was initiated with them. However, the written documentation
in this regard is awaited by their office. The undersigned is of
the view that the quality issues should have been investigated
in detail in the year when it arose i.e. almost six years ago.
The copy of the details of the consignment imported is being
annexed.
4396.
In view of the above, quality issues reported
approximately six years ago can not be investigated now, it is

therefore, recommended that the Drug Regulatory of Pakistan,
Islamabad, may pre-qualify the foreign principle as per SOPs
in vogue to evaluate and pre-qualify current Quality Control
and manufacturing operations of M/s. Shandong Weigao,
China.
4397.
4398.
4399. Case No. 11. Change of Source of Manufacturing Site.
4400.
M/s. BSN Medical (Pvt) Ltd., Karachi have
requested to approve the change of manufacturing site of

following registered imported drug from M/s. Smith &
Nephew Medical Limited, 101 Hassle Road, Hull HU3 2BN,
England to M/s. Smith & Nephew Medical (Suzhou) Limited,
No.12, Wuxiang Road, Comprehensive Free Zone, West Zone,
Suzhou Industrial Park, Jiangsu Province, 215021, China.
423
4401.
M/s. BSN Medical (Pvt) Ltd., Karachi have
deposited required fee and supporting documents notarized /

legalized from China. The documents reveals that;
4402.
4403.
4404.
Na
m
e
4405.
A
o
f
P
r
o
d
u
c
t
s
.
4406.
4407.
4408.
Cica
C
a
r
e
4409.
N
A
d
h
e
s
i
v
e
G
e
424
l
S
h
e
e
t
)
.
4410.
4411.
4412.
Bact
i
g
r
a
s
(
C
h
l
o
r
h
e
x
i
d
i
n
e
4413.
N
A
c
e
t
a
t
e
T
u
l
l
e
G
425
r
a
s
D
r
e
s
s
i
n
g
s
)
.
4414.
4415.
4416.
Opsi
t
e
4417.
A
(
T
r
a
n
s
p
a
r
e
n
t
P
o
l
y
u
r
e
t
h
a
n
e
D
r
426
e
s
s
i
n
g
)
4418.
4419.
4420.
4421. Case No. 12. Change of Source of Manufacturing Site.
4422.
4423. M/s. ICI Pakistan Limited, Lahore have requested for transfer of registration of
the following registered locally manufactured veterinary drugs from the names of previous
manufacturers M/s. Epla Laboratories (Pvt.) Ltd., Karachi and M/s. Breeze Pharma (Pvt.) Ltd.,
Islamabad to their name for local manufacture as they has been issued Drug Manufacturing
License on April, 2015:-
4429.
4426.
N
4427.
Name
4430.
N
4434.
M/s.
4431.
C
4432.
L
427
4433.
4436.
4437.
N
4442.
-do-
4438.
C
4439.
L
4440.
O
4441.
4444.
4445.
Z
4450.
-do-
4446.
C
4447.
O
4448.
4449.
4452.
4453.
S
4456.
-do-
4454.
C
4455.
O
4458.
4459.
4463.
428
-do-
4460.
C
4461.
L
4462.
C
4465.
4466.
N
4472.
-do-
4467.
C
4468.
L
4469.
O
4470.
C
4471.
4474.
4475.
O
4483.
-do-
4476.
C
4477.
O
4478.
El
4479.
(a
4480.
El
429
4481.
(a
4482.
4485.
4486.
A
4490.
M/s.
4487.
C
4488.
A
4489.
S
4492.
4493.
A
4499.
-do-
4494.
C
4495.
A
4496.
Cl
4497.
C
4498.
4501.
4502.
O
4508.
-do-
4503.
430
E
4504.
O
4505.
O
4506.
C
4507.
4510.
4511.
Tr
4516.
-do-
4512.
E
4513.
Tr
4514.
S
4515.
4518.
4519.
Tr
4524.
-do-
4520.
C
4521.
L
4522.
Tr
4523.
4526.
4527.
V
4532.
-do-
4528.
E
431
4529.
O
4530.
Tr
4531.
4534.
4535.
D
4540.
-do-
4536.
E
4537.
T
4538.
D
4539.
4542.
4543.
Li
4549.
Penici
4544.
E
4545.
A
4546.
Li
4547.
S
4548.
Vi
4551.
4552.
N
4558.
-do-
4553.
E
432
4554.
C
4555.
N
4556.
C
4557.
4559.
4560. M/s. ICI Pakistan Limited, Lahore have deposited the required fee and submitted
following supporting documents:4561.
4562.
4563.
4564.
4565.
4566.
4567.
4568.
i)
ii)
iii)
iv)
v)
vi)
Original NOC from M/s. Epla Laboratories (Pvt) Ltd., Karachi.

Copy of initial registration letters & renewal status.
Original NOC from M/s. Breeze Pharma (Pvt.) Ltd., Islamabad.
Copies of initial registration letters & renewal status.
Copy of Drug Manufacturing Licence and approved section.
Applications on Form 5.
Submitted for consideration please.

4569.
4570. Case No.13. Change of Source of Manufacturing Site.

4571.
M/s. Abbott Laboratories (Pakistan) Limited, Karachi
have requested for transfer of registration of the undermentioned registered imported drugs from the name of
previous importer M/s. Highnoon Laboratories Ltd., Lahore to
their name due to an International Acquisition of the
Pharmaceutical Section of Solvay with all associated
companies has been acquired by the Abbott group since
February 15, 2010: 4572.
4574.
4575.
4576.
New
433
4577.
4578.
4579.
4582.
4583.
M/s.
4580.
4581.
4584.
4585.
4586.
4587.
4588.
-do-
4589.
4590.
4591.
4592.
4593.
-do-
434
4594.
4595. They have deposited required fee and case was placed
before the Registration Board in its 239th meeting held on 12th
September, 2013 approved the transfer of registration of
Physiotens Tablet from M/s. Highnoon to M/s. Abbott
Laboratories (Pakistan) Ltd. Karachi along-with the change in
manufacturing site from M/s. Eli Lilly S.A., Spain to M/s.
Rottendrof Pharma GmbH, Germany, while the packaging site
of the finished products will be M/s. Abbott Healthcare SAS,
France. The later on M/s. Abbott Laboratories (Pakistan)
Limited, Karachi have also submitted that both manufacturing
and release site will be M/s. Abbott Healthcare SAS, France.
4596. The Case was again discussed by the Registration Board in
its 246th meeting held on 10-11th December, 2014 and referred
above formulations for consideration of Review Committee.
4597.
4598. Case No.14. Registration of Magnesium Sulphate 15% in Humany products.
4599.
Drug Registration Board in its 243 rd meeting held
on 08-09th May, 2014
considered and approved the
registration of fo llowing drug for import in the name of M/s.

BN
Pharmaceuticals,
Lahore
manufactured
by
M/s.
Laboratories Chaix et Du Marais Lavoisier Head Quarter Paris

France subject to price fixation / calculation:4600.
Name of drug
(s)/Composition.
4601.
D
4602.
/
4603. Sulphate
De
Magnesium Lavoisier
(1.5G/10ML)
15%
4607.Rs.450/Per ampoule.
4608.Rs.4500/Per 10
ampoules.
435
(I.V) Injectable.
4604. Each
ampoule
contains: 4605. Magnesium
as
Sulphate. 1.5g/10ml
(15%).
4606.
4609.
4610.
Meanwhile, the firm M/s. BN Pharmaceuticals,
Lahore have submitted the references in support of above

mentioned product which is already under process of
registration. The firm has also submitted the list of countriesorganizations in which this product is registered / sponsored at
this time along with the report of WHO Drug Information
volume-21/2.2007 WHO Geneva.
4611.
The Magnesium Sulphate 15% is not approved by
any of the reference authorities i.e. EMA, USFDA, TGA or

PDMC, except France.
4612. The Registration Board referred the case to Review
Committee for formulation review.
4613.
436
4614. Registration-II
4615. Case No.15
4616. a.
i.
Cases deferred by Registration Board.
M/s Noa Hemis Pharmaceuticals, Karachi
Registration Board in 235th meeting discussed registration of Fucirin Forte Cream and decided as
recorded in last column.
437
1.
Na
4.
5.
Fu
14.
6.
Ea
7.
So
8.
Be
9.
(A
438
4617.
4618.
The firm has requested for registration of Fucirin Forte Cream in the light of decision of
247th Meeting of Registration Board.

ii.
Registration Board in 238th meeting discussed registration of Ztrol XL Tablet (Alfuzosin HCl
10mg), M/s Noa Hemis Pharmaceuticals, Karachi and decided as recorded in last column.
4619.
N
4623.
Zt
4624.
Ea
4622.
4630.
4631.
4632.
4625.
Al
4626.
(B
4627.
439
4633.
4634.
4635. Now the firm has provided comparative dissolution profile with originator brand
and has requested for grant of registration of Ztrol XL Tablet (Alfuzosin HCl 10mg).
4636. Submitted for consideration of Registration Board
4637.
4638. b)
M/s
Nabiqasim
Pharmaceuticals,
Karachi.
4639. Registration Board in 246th meeting discussed registration of Misocot 50mg

tablets, M/s Nabiqasim, Karachi and decided as recorded in last column.
4640.
N
4645.
M
4646.
E
4651.
4652.
4653.
4643.
R
4644.
4657.
B
4664.
4658.
4654.
4659.
A
4647.
D
4660.
4648.
M
4655.
4656.
4661.
G
4649.
440
4662.
4650.
(
1.Verification of photocopies
of fee submitted is
required.
2.Other strength of the
product Misocot 75 mg
Tablets has already been
deferred for Product
specific inspection by
panel comprising of
Director DTL, DDG
(E&M) and area FID
4663.
4667.
1
4673.
4665.
4666.
4686.
4683.
C
4674.
4668.
2
4684.
4675.
4685.
F
4669.
3
4676.
4670.
D
4677.
4671.
M
4678.
4679.
4672.
4
4680.
4681.
4682.
4687.
4688. Now firm has informed that panel conducted product
specific inspection on 14.04.2015 and reported as follows:
441
4689. Based on the areas inspected, the people met and the
documents reviewed, and considering the findings of the
inspection, and production, quality control, storage and
HVAC facilities provided by the management, panel
recommends the registration of the products.
1. Tab. Misocot 50mg (Diclofenac sodium: 50mg & Misoprostol 200mcg)
2. Tab. Misocot (Diclofenac sodium: 75mg & Misoprostol 200mcg)
4690. Keeping in view the possible risk of the ingredient
(Misoprostol) of producing side offects/mis-use, panel also
recommends
that,
precautionary
instructions
/
contraindications should be clearly mentioned on the on the
product & leaflet in bold letters. Moreover, the measures to be
taken for the safety concerns of the products should also be
discussed in the registration board, DRAP, Islamabad.
4691.
4692. c)
M/s. Espoir Pharmaceutical (Pvt) Ltd.,
Karachi.
4693. Registration Board in 241st meeting deferred following
products for reason recorded in last column as follows:
4694.
N
4699.
1.
4703.
4704.
4697.
4698.
4709.
4711.
4710.
4700.
2.
4705.
4706.
4701.
3.
4707.
4708.
4702.
4.
442
4712.
4713.
1.
4717.
4718.
4723.
4725.
4724.
4714.
2.
4719.
4720.
4715.
3.
4721.
4722.
4716.
4.
4726.
1.
4730.
4731.
4727.
2.
4732.
4733.
4728.
3.
4734.
4736.
4738.
4737.
4735.
4729.
4.
4739.
1.
4743.
4744.
4740.
2.
4745.
4746.
4741.
3.
4747.
4749.
4751.
4750.
4748.
4742.
4.
4752.
4753. Now firm has intimated that panel of experts comprising of
Javed Yousaf Buakri, Dr.saif ur Rehman Khattak and Abdul
443
Rasool Shaikh, FIDinspected the firm on 08.05.2014 and

concluded as follows:
4754. The panel of Inspection has stated that:
i.
After a detailed visit during which the entire production, premises, QA, QC
documentations etc were reviewed, their overall GMP compliance level during static
conditions is rated as GOOD.
4755.
ii.
Keepingin view the above stated static conditions the panel unanimously recommends
the resumption of their production activities while adhering to strict GMP compliance
after the formal approval from concerned Division / Board.
4756.
iii.
It is also recommended that the level of compliance may be monitored during their
active productions, with the permission of the concerned Division.
4757.
4759. d.
M/s Nawan Laboratories (Pvt) Ltd, Karachi.
4760. Registration Board in 209th meeting approved following products for reason
recorded in last column as follows:
4761.
Na
4764.
Deci
s
i
o
n
o
f
2
0
9
th
4765.
Ma
4770.
m
e
e
ti
n
g
4771.
Appr
444
4766.
Eac
4767.
Iro
4768.
(Ha
4769.
o
v
e
d
s
u
b
j
e
c
t
t
o
q
u
a
li
t
y
a
s
s
e
s
s
m
e
n
t
d
o
s
s
i
e
r
s
f
o
r
s
t
a
b
445
il
it
y
s
t
u
d
i
e
s
a
n
d
v
a
li
d
a
ti
o
n
o
f
n
o
n
p
h
a
r
m
a
c
o
p
e
i
a
l
t
e
s
ti
n
446
g
m
e
t
h
o
d
s
a
s
p
e
r
p
o
li
c
y
.
4772.
Com
p
a
r
a
ti
v
e
d
i
s
s
o
l
u
ti
o
n
p
r
o
fi
l
e
447
s
w
it
h
t
h
e
i
n
n
o
v
a
ti
v
e
p
r
o
d
u
c
t
s
s
u
p
p
o
rt
e
d
w
it
h
t
h
e
e
v
i
d
e
n
448
c
e
s
4773.
and
q
u
a
li
fi
e
d
s
t
a
f
f
s
u
b
j
e
c
t
t
o
i
n
s
p
e
c
ti
o
n
b
y
t
h
e
o
f
e
x
449
p
e
rt
s
c
o
n
s
i
s
ti
n
g
o
f
4774.
i. Mr.
S
h
e
i
k
h
F
a
q
e
e
r
M
u
h
a
m
m
a
d
S
h
e
i
k
h
(
450
D
D
G
P
ri
c
i
n
g
),
4775.
ii.
O
b
a
i
d
A
li
(
A
D
C
)
4776.
iii.
S
h
.
R
a
s
h
i
d
A
h
m
e
d
,
F
I
451
D
4777.
4778.
Ma
4783.
4784.
-do4785.
4792.
4793.
-do4794.
4800.
4802.
-do4803.
4779.
Eac
4780.
Iro
4781.
(Ha
4782.
4786.
Ma
4787.
Eac
4788.
Iro
4789.
Fol
4790.
(Ha
4791.
4795.
Le
4801.
4796.
Eac
4797.
Le
4798.
452
(Br
4799.
4804.
Le
4809.
4810.
4811.
-do4812.
4805.
Eac
4806.
Le
4807.
(Br
4808.
4813.
Cef
4818.
4819.
4820.
-do4821.
4814.
Eac
4815.
Cef
4816.
(A
4817.
4822.
Cef
4823.
Eac
4827.
4828.
-do4829.
4830.
4824.
Cef
4825.
(A
4826.
453
4831.
Ga
4836.
4838.
-do4839.
4837.
4832.
Eac
4833.
Ga
4834.
(A
4835.
4840.
4841. Now firm has informed that above panel could not inspect the facility and during
this time above sections have been inspected many times and declared as good. The firm has paid
fee up to Rs. 20,000/- for each product and have submitted new Form 5 as per check list
approved by Registration Board and requested for approval of above drugs.
4843.
4844. e.
4845.
M/s Sami Pharmaceutical, Karachi.

Registration Board in 247th meeting approved
following products for reason recorded in last column as follows:

4846.
Na
m
e
4849.
4850.
o
f
D
r
u
g
454
&
c
o
m
p
o
s
i
t
i
o
n
4851.
Eni
e
r
2
4
m
g
T
a
b
l
e
t
4852.
Eac
h
4856.
4861.
4866.
4857.
4858.
4859.
4860.
4862.
4863.
4864.
4865.
t
a
b
l
e
t
c
o
n
455
t
a
i
n
s
:
4853.
Bet
a
h
i
s
t
i
n
e
d
i
h
y
d
r
o
c
h
l
o
r
i
d
e
(
B
.
P
)
.
2
4
m
g
456
4854.
(An
t
i
h
i
s
t
a
m
i
n
e
,
a
n
t
i
v
e
r
t
i
g
o
)
4855.
(B.
P
S
p
e
c
.
s
)
4867.
4868. Now the firm has stated that their ENIER 8mg & 16mg Tablets
are already registered under Drugs Registration No. 067164 &
067165 respectively and marketed since 2011. The firm has
457
informed that their Trademark and copyright of ENIER has

already been registered by the Trademarks Registry, Government
of Pakistan under Trademark Act 1940, under registration No.
292134 and design under copyright Ordinance 1962 under
registration No. 28682-Copr. The company has requested for
issuance of Registration letter for ENIER 24mg.
4870. f.
Pharmatec Pharmaceuticals, Karachi.
4871. Registration Board in 237th meeting considered following

product and decided as recorded in last column as follows:
4872.
Na
m
e
4875.
4876.
4882.
4888.
o
f
D
r
u
g
&
c
o
m
p
o
s
i
t
i
o
n
4877.
K-
4881.
458
C
i
t
T
a
b
l
e
t
4878.
Eac
h
4883.
4884.
4885.
4886.
4887.
e
x
t
e
n
d
e
d
r
e
l
e
a
s
e
t
a
b
l
e
t
c
o
n
t
a
459
i
n
s
:
4879.
Pot
a
s
s
i
u
m
C
i
t
r
a
t
e
.
.
1
0
8
0
m
g
4880.
(NS
A
I
D
)
460
461
4889.
4890. The committee later on deferred the case for confirmation of
me too. The firm has stated that Urocit K Tablet, Registration
No. 039808, Allmed Laboratories is already registered drugs. Firm
has also informed that being an extended release tablet
comparative dissolution test with Urocit-K had already been
performed in an independent lab H.E.J. research institute of
Chemistry, University of Karachi. The firm has provided sample
analysis / comparative dissolution test report.

4892. g.
4893.
Safe Pharmaceuticals, Karachi.
Following products of M/s. Safe Pharmaceutical (Pvt) Ltd., Karachi were approved by
Registration Board in various meetings as recorded in last column. Now firm has deposited balance fee
amounting to Rs. 12,000/- for each product and requested for issuance of registration letter. Firm has
segregated psychotropic section approved by Central Licensing Board.
4895.
P
4897.
4900.
E
4904.
4905.
4901.
E
4906.
4898.
4909.
4902.
C
4903.
(
4911.
E
4912.
E
4913.
462
E
4914.
(
4915.
4921.
E
4922.
E
4923.
E
4924.
(
4925.
4931.
S
4932.
E
4933.
A
4934.
(
4935.
4941.
A
4947.
4950.
4942.
E
4943.
A
4944.
463
(
4945.
4951. h.
PharmEvo Pharmaceuticals, Karachi.
4952. i.
Registration Board in its 237th meeting discussed
registration of following products of M/s PharmaEvo, Karachi and

decided as recorded in last column.
4953.
Pro
d
u
c
t
4955.
4956.
Decis
4962.
4963.
Confi
N
a
m
e
&
C
o
m
p
o
s
i
t
i
o
n
4957.
Osie
n
D
G
r
a
464
n
u
l
e
s
f
o
r
S
u
s
p
e
n
s
i
o
n
E
a
c
h
5
m
l
4964.
Speci
c
o
n
t
a
i
n
s
4958.
Ossi
e
n
465
M
i
n
e
r
a
l
C
o
m
p
l
e
x
8
3
0
m
g
4959.
Vita
m
i
n
D
3
.
.
4
0
0
I
U
4960.
(Ant
i
466
O
s
t
e
o
p
o
r
o
t
i
c
)
4965.
Osie
n
4971.
4972.
Confi
D
T
a
b
l
e
t
4966.
Eac
h
t
a
b
l
e
t
c
o
n
t
a
467
i
n
s
4967.
Ossi
e
n
4973.
M
i
n
e
r
a
l
C
o
m
p
l
e
x
8
3
0
m
g
4968.
Vita
m
i
n
D
3
.
.
468
4
0
0
I
U
4969.
(Ant
i
O
s
t
e
o
p
o
r
o
t
i
c
)
4974.
4975.
The firm is now equipped with Atomic Absorption
facility required for the testing of the above products and same has
been confirmed by FID in inspection report dated 20.03.2013.
4976.
4977. ii.
Registration Board in various meetings discussed
registration of following products of M/s PharmaEvo, Karachi and

4978.
P
4980.
4981.
4982.
V
4987.
4988.
4983.
E
4989.
469
4984.
V
4985.
(
4990.
V
4995.
4991.
E
4992.
V
4993.
(
4997.
E
5002.
5003.
5004.
4998.
E
4999.
E
5000.
(
5005.
E
5010.
5011.
5012.
5006.
E
5007.
E
5008.
(
5013.
5014.
Now firm has submitted remaining fee and requested for
issuance of registration letter.
470
5015. iii.
Registration Board in its 238th meeting discussed
registration of following product of M/s PharmaEvo, Karachi and

5016.
P
5018.
5019.
De
5020.
B
5026.
5028.
De
5027.
5021.
E
5029.
ii.
5022.
I
5023.
(
5030.
B
5036.
5037.
5038.
De
5031.
E
5039.
ii.
5032.
I
5040.
5033.
(
5041.
5042. M/s PharmEvo has submitted remaining fee and informed that
products are available in EU markets with brand name of Spedifen
by M/s Zambon.
5043.
471
5044.
5045.
i.
M/s Reign Pharmaceutical PCSIR KLC Karachi.

5046.
M/s Reign Pharmaceutical PCSIR KLC Karachi has informed that their following
products were discussed in 239th Registration Board. The Board has deferred the case as per last column:-
472
5080.
5081. Product
at
S.No.01
is
already
registered
(Registration
No.016687) for M/s Himont Pharma and requested for registration

of drug. Submitted for consideration of Registration Board.
5082.
5083.
5084. j.
M/s Macter International, Karachi.
5085. i.
Ultima XL Tablet.
5086. Registration Board in 237th meeting discussed following

products and decided as follows:
5087. Na
me of
Drug
&
Comp
ositio
n
5091. Ult
ima
XL
Tablet
5092. Eac
h
extend
ed
release
tablet
contai
ns:
5093. Cla
rithro
mycin
..50
0 mg
5094. (an
tibioti
5095.
5096.
5089.
5090.
5097.
5103.
5098.
5099.
5100.
5101.
5102.
473
c)
5104.
5105. Data provided by the firm were sent to experts, who forwarded
following reports:
5106.
D
5108.
Dr.
5109.
Mr.
5107.
474
475
5110.
A
5112.
The
5113.
Thr
The firm has

carried out stability testing as
per guidelines.
The firm has
carried out comparative
dissolution study of the said
product as per guidelines.
5111.
K
476
477
478
479
480
The
Comparative
Dissolution Profile with
Innovator Brand has
been carried out as per
guidelines.
5114.
The
481
482
483
5115.
5116.
ii.
5117.
Tamsin Capsule 0.4mg.

Registration Board in 212th meeting discussed following products and decided as follows:
5118.
Ta
5123.
5124.
Ap
5119.
Ea
5125.
5120.
Ta
5121.
(A
5122.
5126.
5127. Data provided by the firm were sent to experts, who forwarded
following reports:
5128. D
r.
A
ma
nul
lah
Kh
an
Dir
ect
or,
Dr
5130.
5131.
Mr.
484
ug
Tes
tin
g
La
bor
ato
ry,
Go
ver
nm
ent
of
Bal
uc
his
tan
,
5129. Q
uet
ta.
485
5132. A
fter
tho
rou
gh
rev
iew
of
the
sta
bili
ty
dat
a
of
TA
MS
IN
CA
PS
UL
E
0.4
M
G
OF
M
AC
TE
R
5134.
5135.
Com
486
IN
TE
RN
AT
IO
NA
L,
KA
RA
CH
I
sub
mit
ted
by
the
fir
m,
the
exp
ert
sci
enti
fica
lly
and
log
ical
ly
co
m
me
nts
as
und
er:
The firm has not carried out

comparative dissolution study of
the said product as per guidelines.
5133.
Keeping in view the data

provided the undersigned justifies
not to recommend the registration
487
of the TAMSIN CAPSULE 0.4MG

(Tamsulosin
HCl.0.4mg)
product in favour of the firm.
5136.
488
5138.
i.
5139. Case No.16:
Registration of Drugs for export purpose
5140.
Following firms have requested for registration
Non me too Drugs.
of following drugs for export purpose only and submitted

application on Form 5, as per following detail:5141.
5142.
5143.
Nam
5144.
5145.
5146.
5147.
5149.
Anpl
5152.
5156.
5153.
5148.
5154.
5155.
5150.
Each
489
5151.
Tica
5157.
5158.
5159.
Xag
5162.
5165.
5163.
5164.
5160.
Each
490
5161.
Saxa
491
5166.
5167.
5168.
Xag
5172.
5175.
5173.
5174.
5169.
Each
5170.
Saxa
492
5171.
Metf
5176.
5177.
5178.
Lina
5181.
5184.
5182.
5183.
5179.
Each
493
5180.
Ling
5185.
5186.
5187.
Xag
5191.
5194.
5192.
5193.
5188.
Each
494
5189.
Saxa
5190.
Metf
495
5195.
5196.
5197.
Zilsa
5200.
5203.
5201.
5202.
5198.
Each
5199.
Azils
496
5204.
5205.
5206.
Zilsa
5210.
5213.
5211.
5212.
5207.
Each
5208.
Azils
5209.
497
5214.
5215.
5216.
Nov
5220.
5223.
5221.
5222.
5217.
Each
5218.
498
Sofo
5219.
5224.
5225.
5226.
Cuve
5229.
5232.
5230.
5227.
Each
5231.
499
5228.
Sofo
5233.
5234.
5235.
Sofo
5238.
5240.
5239.
5236.
Each
500
5237.
Ledi
501
5241.
5242.
5243.
Davi
5246.
5248.
5247.
5244.
Each
502
5245.
Dacl
5249.
5250.
5251.
Davi
5254.
5256.
5255.
5252.
Each
503
5253.
Dacl
5257.
5258.
5259.
Kid-
5271.
5273.
5272.
504
5260.
Each
5261.
Ribo
505
5262.
Thia
5263.
Niaci
5264.
Pant
506
5265.
Pyrid
5266.
Bioti
5267.
Folic
5268.
Meth
507
5269.
Asco
5270.
Vita
508
5274.
5275.
5276.
Biof
5284.
5286.
5285.
5277.
Each
509
5278.
L-
5279.
Vita
510
5280.
5281.
5282.
5283.
5287.
5288.
5290.
Ledi
5294.
5297.
5295.
5296.
5289.
5291.
511
Each
5292.
Ledi
5293.
Sofo
512
5298.
5299.
5300.
Invo
5302.
5305.
5303.
5304.
5301.
Each
513
5306.
5307.
5308.
Invo
5310.
5313.
5311.
5312.
5309.
Each
514
5314.
5315.
5316.
Co-
5319.
5322.
5320.
5321.
5317.
Each
515
5318.
Azils
5323.
5324.
5325.
Co-
5328.
5331.
5329.
5330.
516
5326.
Each
5327.
Azils
5332.
5333.
5334.
Azet
5337.
5339.
5338.
517
5335.
Each
5336.
Azils
5340.
5341.
5342.
Azet
5345.
5347.
5346.
518
5343.
Each
5344.
Azils
5348.
5349.
5350.
Azet
5353.
5355.
5354.
5351.
Each
519
5352.
Azils
5356.
5357.
5358.
Sofol
5362.
5364.
5363.
5359.
Each
520
5360.
Sofo
5361.
Ledi
521
5365.
5366.
5367.
5368.
5369. ii.
Contract Manufacturing:
5370.
5371.
5372.
5373.
N
5374.
5375.
5376.
5377.
5378.
S
5381.
5379.
E
5382.
5383.
5380.
C
5384.
5385.
5386.
5387.
S
5390.
5388.
E
5391.
5392.
5389.
C
5393.
5394.
5395.
5396.
A
5399.
5397.
5400.
522
E
5401.
5398.
C
5402.
5403.
5404.
5405.
A
5408.
5406.
E
5409.
5410.
5407.
C
5411.
5412. iii.
Registration of Weletro (Letrozole) Tablet for export
purpose.
5413.
M/s Kaizen Pharmaceutical (Pvt) Ltd., Karachi
has requested for registration of drugs Weletro (Letrozole) Tabletfor

export purpose. As manufacturing requirement of letrozole is under
discussion, thus case is submitted for consideration of Registration
Board.
5414.
5415.
5416.
5417.
5418.
Case No.17: Intimation for discontinuation of production of their marketed

product: Trevia (Sitaglipting) Tablets 25mg
5419.
M/s Getz Pharma, Karachi has intimated that under Rule
30 of Drug (Licensing, Registering and Licensing) Rules,

1976which states to intimate Registration Board about the
circumstance which may lead to reduction in the production of drug
and may result in its shortage. This is for information that Trevia
523
(Sitagliptin) Tablets 25mg is their registered and marketed product.

Dose of 25mg is not recommended in general population. Wile, in
special population like several renal compromised patients with
CrCI < 30ml/min where such dose can be considered, are normally
managed with injection. Since the demand is far lesser than the
minimum batch quantity of said product which can be manufactured
on the equipment. On the basis of the reason mentioned above, the
company will no longer be able to continue the production of Trevia
(Sitagliptin) Tablets 25mg.

5421.
5422.
Case No.18: Rectification in composition of Adalin Syrup (Addition of Menthol

0.98mg/5ml).
5423.
M/s Macter International Limited, Karachi has
informed that the label claim of Menthol (0.98mg/5ml) in the

registration letter of their registered Product namely Adalin Syrup,
Registration No. 011754 as follows: 5424. Comp
osition
in
current
registrati
on
certificat
e
5426. Comp
osition
5427. Each
5ml
contains:
5428. Amin
ophylline
BP
..30
mg
5425. Comp
osition
applied
for
updated
(rectified
in
registrati
on
letter).
5432. Comp
osition
5433. Each
5ml
contains:
5434. Amin
ophylline
BP
..30
mg
524
5429. Amm
onium
Chloride
BP
32mg
5430. Diphe
nhydrami
ne
HCl
.8mg
5431.
5435. Amm
onium
Chloride
BP
32mg
5436. Diphe
nhydrami
ne
HCl
.8mg
5437. Ment
hol
0.098mg
5438.
5439. There is no change of Formulation/composition in this regard,
Menthol was already in their formulation since its registration as
an exceipient however they would like to claim it an active as per
registered Product of competitors / brand leaders like Hydryllin by
Searle Pharma, Xantorant Syrup by Life Pharma. The firm has
deposited Rs. 20,000/- for updating /rectification in registration
letter.

5441.
5442.
Case No.19:
Permission for manufacturing of drug at own site.

5443.
Following product of M/s OBS Pakistan Karachi
has been permitted for contract manufacturing from M/s Highnoon,

Lahore and valid till 30.06.2015. Now firm has requested for
permission at own manufacturing facility, as they have developed
their own hormone tablet facility.
5445.
5447.
5448.
Pro
525
5449.
5450.
5453.
5454.
5455.
OB
5451.
5452.
5456.
5457. In support to the firm has provided following documents:
i)
ii)
iii)
iv)
v)
vi)
5458.
Application with prescribed fee amounting to Rs. 50,000/Drug Manufacturing License.

Pharmacological and Clinical Data.
Proposed shelf life of the drugs.
Evidence of International Availability of Product.
Approved section of Tablet (Hormones)

5460.
5461.
Case No.20:
Extension in Contract Manufacturing Permission.
526
5462.
Following firms have requested for extension in
contract manufacturing permissions of drugs as per following

details:
5463.
1.
5464.
5465.
5466.
5472.
5467.
5468.
5469.
5473.
5476.
5478.
5474.
5475.
2.
5481.
5482.
5486.
5483.
5484.
3.
5489.
5490.
5494.
527
5491.
5492.
4.
5497.
5498.
5506.
5499.
5500.
5501.
5502.
5503.
528
5504.
5.
5509.
5510.
5513.
5516.
5511.
5512.
6.
5519.
5520.
5524.
5521.
5522.
7.
5527.
5528.
5532.
529
5529.
5530.
8.
5535.
5536.
5540.
5537.
5538.
9.
5543.
5544.
5548.
5545.
5546.
530
10.
5551.
5552.
5556.
5553.
5554.
11.
5559.
5560.
5563.
5566.
5565.
5561.
5562.
12.
5569.
5570.
5574.
531
5571.
5572.
13.
5577.
5578.
5582.
5579.
5580.
14.
5585.
5586.
5590.
5587.
5588.
532
15.
5593.
5594.
16.
5600.
5595.
5601.
5606.
5607.
5610.
5608.
5611.
5612.
17.
5604.
5605.
5614.
5613.
5609.
18.
5615.
5616.
5617.
5618.
5621.
5625.
5622.
5623.
5626.
5624.
5619.
5620.
19.
5627.
5628.
5629.
5630.
5633.
5637.
533
5634.
5635.
5638.
5636.
5631.
5632.
20.
5639.
5640.
5641.
5642.
5643.
5645.
5649.
5646.
5647.
5650.
5648.
5644.
5651.
5652.

5654.
5655.
5656.
5657.
534
5658.
5659.
5660.
Case No.21
Registration of drugs from manufacturer / importer to another
manufacturer / importer.
5661. a)
M/s. Pliva Pakistan (Pvt) Ltd, Karachi.
5662. i.
Following product is registered for M/s Mehran
International, JM 798/D, Hume Road, Quaideen Colony Opposite:

World Map, Near 3 Star Hall, Karachi Pakistan for import from
M/s. Pliva Zagreb Croatia, Yogoslavia and now M/s. Pliva Pakistan
(Pvt) Ltd, Karachi have requested for transfer of registration of the
following
registered
imported
drug
from
the
name
of
aforementioned agent for local manufacturing.

5663.
5664.
5665. Name of
Products
5667.
5668. Amoxicillin
Injection 1gm
5669. Each vial
contains:
5670. Amoxicillin
as sodium
Salt 1gm
5671.
5672. The applicant M/s. Pliva Pakistan (Pvt) Ltd. Karachi has
submitted following documents:i)
ii)
iii)
iv)
v)
Copy of registration letter and renewal status

NOC from M/s Mehran International, Karachi for manufacturing of Amoxycillin
Injection 1gm (Reg No 008620).
NOC from M/s Pilva Zagreb, Croatia for Amoxycillin Injection 1gm (Reg No 008620).
Form 5
Copy of last inspection report
5673.
5674. ii.
Following product is registered for M/s Shaheen Agency,
Karachi for import from M/s. Chongqing Medicines and Health

535
Products Chongqing China and now M/s. Pliva Pakistan (Pvt) Ltd,
Karachi have requested for transfer of registration of the following
registered imported drug from the name of aforementioned agent
for local manufacturing.
5675.
5676.
5677. Name of
Products
5679.
5680. Ampicloxacil
lin Sodium
Injection 500mg
5681. Each vial
contains:
5682. Amicillin
Sodium eq to
Ampicillin
250mg
Cloxacillin
Sodium eq to
Cloxacillin
250mg
5683.
5684.
The applicant M/s. Pliva Pakistan (Pvt) Ltd. Karachi has
submitted following supporting documents:i)

ii)
iii)
iv)
v)
vi)
Request for transfer of registration along with prescribed fee for each product
amounting to Rs. 20,000/- for each product.
NOC from M/s Shaheen Agency for manufacturing of Ampicloxacillin Sodium
Injection 500mg (Reg No. 013262).
NOC from Chongqing Medicine and Health Product Chongqing China for
Ampicloxacillin Sodium Injection 500mg (Reg No. 013262).
Registration letter and renewal status
Form 5.
Copy of last inspection report.
5685.

5687.
5688.
b.
Registration from M/s Seatle (Pvt) Ltd., to M/s Martin Dow Ltd, Karachi.
5689.
536
5690.
Registration
Board
in
237th
meeting
approved
registration of Eurosin Capsule 0.4 mg containing Tamsulosin from

M/s Seatle (Pvt) Ltd., to M/s Martin Dow Ltd, Karachi.The firm has
submitted balance fee @ Rs.100000/-, GMP certificate, Certificate
of analysis and Stability data of product because is in pelletization
form. The firm will purchase pellets of Tamsulosin HCl 0.4mg from
M/s Vision Pharma, Islamabad.
5691. Firm has submitted registration application as Form 5 and evaluated as per check
list. Submitted for consideration of Registration Board
5692. c.
5693.
M/s Bosch Pharmaceutical (Pvt) Ltd., PlantII.
M/s Bosch Pharmaceutical (Pvt) Ltd., Karachi has requested for transfer of registration
from M/s Bosch Pharmaceuticals (Pvt) Ltd., Karachi DML No. 000350 to Bosch Pharmaceutical (Pvt)
Ltd., Plant II Situated at Plot No. 209, Sector 23, Korangi Industrial Area, Karachi having DML No.
000707: -
5698.
5705.
5712.
5695. Product for

registration with
generic name
5699. Tariflox
200mg
Infusion
5700. Each
100ml
contains:
5701. Ofloxacin
USP..200mg
5702. (Manufacturers
Specification
5706. Quinoflox 100mg
Infusion
contains
5708. Ciprofloxacin
Lactate M.S. eq. to
100mg Ciproflxacin
USP
Sodium
Chloride..450mg
5709. (USP Specification)
Infusion
5696.
5697.
5703.
5704.
5710.
5711.
5717.
5718.
537
5719.
5726.
5733.
5740.
5747.

contains:
5715. Ciprofloxacin
Lactate M.S. eq. to
200mg Ciproflxacin
USP
Sodium
Chloride..900mg
Infusion
contains:
5722. Ciprofloxacin
Lactate M.S. eq. to
400mg Ciproflxacin
USP
5727. Quinoflox
DS
400mg/100ml Infusion
contains
5729. Ciprofloxacin
Lactate M.S. eq to
400mg Ciproflxacin
USP.400mg
5734. Troz 500mg IV
Infusion
contains:
5736. Metronidazole
USP.50mg
5741. Qumic
500mg
Infusion
contains:
5743. Levofloxacin
Hemihydrate
USP
512.46mg
eq
to
levofloxacin.500mg
Specification)
5748. Qumic 750mg /
150ml Infusion
5724.
5725.
5731.
5732.
5738.
5739.
5745.
5746.
5753.
5754.
538

contains:
5750. Levofloxacin (as
Hemihydrate)
750mg
eq
to
levofloxacin.500mg
Specification)
5752.
5756. Qumic
250mg/50ml Infusion
5757. Each 50ml contains
Levofloxacin
(as
Hemihydrate)
.250mg
Specification)
5755.
5759.
5760.
5761.
5762. The firm have provided following documents with support:
1)
2)
3)
4)
5)
6)
Application with form 5 and requirement fee amounting to Rs. 20,000/- each.
Copy of registration letter with renewal status
Copy of approved Section by Central Licensing board.
Copy of NOC for CRF Clearance.
Copy of last inspection report.
NOC from Existing Manufacturer/registration holder, permitting for transfer of product.
5763.
5764.
5765.
5766. d.
5767.
M/s Sanofi aventis Pakistan Limited, Karachi:
M/s Sanofi aventis Pakistan Limited, Karachi has requested for transfer of registration of
Deep Rup Gel 25mg Tube (Registration No. 014470) from Wah to Karachi site Sanofi Aventis.
5768. Name of Drug &
composition
5771. Deep Rub Gel
5772. Each gm contains:
5773. Ketoprofen
BP..25mg
Specification
5769.
5770.
5775.
5776.
539
5777.
1)
2)
3)
4)
Copy of registration letter.
Copy of approved Section by Central Licensing Board.
Firm has not provided renewal status of the product
5779.

5781.
5782.
e.
Registration from M/s Johnson & Johnson (Pvt) Ltd to M/s Aspin Pharma (Pvt)
Ltd, Karachi.
5783.
5784.
M/s Aspin Pharma (Pvt) Ltd, Karachi has inform that the Licensing Board in its meeting
has approved the change of name of M/s Johnson & Johnson (Pvt) Ltd for both drugs licenses i.e. DML
No. 000054 Basic Manufacture and DML No. 000045 Formulation. The board also approved the
change of management of the both licensed units. The firm has applied on form 5 and copy of the
product dossiers and new art work of 16 products. The firm has requested for transfer of registration of
Product in the name M/s Aspin Pharma (Pvt) Ltd. M/s Johnson & Johnson has also consented for transfer
of registration. The details are as under:
5788.
5786.
Name
of
D
r
u
g
&
c
o
m
p
os
iti
o
n
5789.
5787.
5791.
540
5792.
Dakta
c
or
t
C
re
a
m
5790.
Micro
n
az
ol
e
2
%
+
H
y
dr
o
c
or
ti
so
n
e
5793.
Dakta
ri
n
C
re
a
m
c
o
nt
ai
ns
:
5794.
Mico
n
5795.
541
5796.
5800.
az
ol
e
N
itr
at
e
2
%
5797.
Dakta
ri
n
cr
ea
m
5798.
Mico
n
az
ol
e
5801.
Gyno
D
a
kt
ar
in
C
re
a
m
2
0
m
g/
g
m
c
o
5799.
5803.
542
5804.
nt
ai
ns
:
5802.
Mico
n
az
ol
e
N
itr
at
e
2
%
5805.
Imodi
u
m
C
a
ps
ul
es
2
m
g
5806.
Each
ca
ps
ul
e
c
o
nt
ai
ns
:
5807.
Loper
a
m
5808.
543
5809.
id
e
H
y
dr
o
c
hl
or
id
e
..
2
m
g
5810.
Motili
u
m
S
us
p
e
ns
io
n
1
m
g/
m
l
5811.
Each
5
m
l
c
o
nt
ai
ns
:
5812.
5813.
544
5814.
Demp
er
id
o
n
e
.1
m
g
5815.
Motili
u
m
Fi
l
m
c
o
at
e
d
ta
bl
et
5816.
Each
fil
m
c
o
at
e
d
ta
bl
et
c
o
nt
ai
ns
:
5818.
545
5819.
5823.
5817.
Dome
ri
d
o
n
e
1
0
m
g
5820.
Motili
u
m
V
Fi
l
m
C
o
at
e
d
T
a
b
5821.
Domp
er
id
o
n
e
M
al
ea
te
5824.
Nizor
al
C
re
5822.
5827.
546
5828.
a
m
2
0
m
g/
g
m
5825.
Per
gr
a
m
c
o
nt
ai
ns
:
5826.
Ketoc
o
n
o
z
ol
e
.2
0
m
g
5829.
Sibeli
u
m
C
a
ps
ul
e
5
m
g
5831.
547
5832.
5830.
Fluna
ri
zi
n
e
H
y
dr
o
c
hl
or
id
5833.
Spora
n
o
x
C
a
ps
ul
e
1
0
0
m
g
5834.
Each
ca
ps
ul
e
c
o
nt
ai
ns
5835.
Itraco
n
az
5836.
548
5837.
ol
e
.1
0
0
m
g
5838.
Stuge
ro
n
F
or
t
C
a
ps
ul
e
7
5
m
g
5839.
Each
ca
ps
ul
e
c
o
nt
ai
ns
:
5840.
Cinna
ra
zi
n
5841.
549
5842.
5847.
.7
5
5843.
Stuge
ro
n
T
a
b
2
5
m
g
5844.
Each
ta
bl
et
c
o
nt
ai
ns
5845.
Cinna
ra
zi
n
e
..
2
5
m
g
5848.
5846.
5851.
550
5852.
5853.
Verm
o
x
T
a
b
5
0
0
m
g
5849.
Each
ta
bl
et
c
o
nt
ai
ns
:
5850.
Mebe
n
d
az
ol
e
.5
0
0
m
g
5854.
Verm
o
x
S
us
p
5857.
551
5858.
e
ns
io
n
2
%
5855.
Each
5
m
l
c
o
nt
ai
ns
5856.
Mebe
n
d
az
ol
e
.1
0
0
m
g
5859.
Verm
o
x
T
a
bl
et
1
0
0
m
g
5862.
552
5860.
Each
ta
bl
et
c
o
nt
ai
ns
:
5861.
Mebe
n
d
az
ol
e
.1
0
0
m
g
5863.
5864.
f.
Registration from M/s Elko Organization, Karachi to M/s Sante (Pvt) Ltd.,
Karachi.
5865.
M/s Sante (Pvt.) Ltd, 97-A, S.I.T.E, Super Highway, Karachi has requested for
transfer of registration of following products from M/s Elko Organization, Karach to their new name:5868.
5869. Com
position
1.
5871.
5872. Each
ml
contains
:
5873. Tobr
553
5868.
5869. Com
position
amycin
3mg
5874. Dexa
methaso
ne 1mg
2.
5876.
3.
5881.
4.
5882.
5886.
5877. Each
gm
contains
:
5878. Sulfa
cetamid
e
Sodium
100mg,
5879. Pred
nisolone
Acetate
2.0mg
5883. Each
ml
contains
:
5884. Pred
nisolone
Acetate
10mg
5887. Each
554
5868.
5869. Com
position
5.
5892.
6.
5895.
7.
5899.
ml
contains
:
5888. Sulfa
cetamid
e
Sodium
100mg,
5889. Pred
nisolone
Acetate
2.0mg,
5890. Phen
ylepheri
ne HCl
1.2mg
5893. Each
gm
contains
:
Dexame
thasone
USP
1.0mg
5896. Each
gm
contains
:
Tobram
ycin
3.0mg
5897. Dexa
methaso
ne
1.0mg
5900. Each
555
5868.
5869. Com
position
ml
contains
:
Ofloxaci
n 3.0mg
5901. Dexa
methaso
ne
1.0mg
8.
5903.
9.
5909.
5904. Each
gm
contains
:
5905. Dexa
methaso
ne (as
Sodium)
1.0mg
5906. Neo
mycin
(as
Sulphate
) 3.5mg
5907. Poly
myxin B
Sulfate
6000uni
ts
5910. Each
ml
contains
:
5911. Dexa
methaso
ne as
Sodium
556
5868.
5869. Com
position
5912. Phos
phate
1mg
5913. Moxi
floxacin
e as HCl
5mg
5914.
1)
2)
3)
4)
Copy of approved Section by Central Licensing board.
NOC from existing manufacturer/registration holder permitting for transfer of product.
5916.
5918.
g.
Registration from M/s OBS Pakistan, Karachi to M/s AGP (Pvt) Ltd.,
Karachi.
5919.
M/s AGP (Pvt) Ltd., Karachi has requested for transfer of registration of
following products from M/s OBS Pakistan, Karachito their new name:-
5921.
1.
5924.
5922. Nam
e of
product
(s) &
composi
tion
5925. Vico
pin
500mcg
Tablet
5926. Each
tablet
contains
5923.
5929.
557
5921.
2.
5930.
5922. Nam
e of
product
(s) &
composi
tion
:
5927. Meco
balamin
500mcg
5928. (Man
ufacture
rs
specifica
tions)
5931. Vico
pin
500mcg/
ml
Tablet
5932. Each
ml
contains
:
5933. Meco
balamin
500mcg
5934. (Man
ufacture
rs
specifica
tions)
5923.
5935.
5936.
1)
2)
3)
5939.
NOC from existing manufacturer/registration holder permitting for transfer of product.
5938.
5940.
558
5941.
Case No.22
Renewal of Drug Manufacturing License No. 000541 (Formulation)
Show Cause Notice.
5942.
No.F2-9/2006-Lic
Licensing Division has informed vide letter

(Vol-I)
dated
13.03.2015
that
Drug
Manufacturing License (DML No. 000541) (formulation) of M/s

Klifton Pharma Located at Plot # E-37 and 38, Port Qasim, Karachi
has been invalid as per Rule 5(3) of Drugs (Licensing, Registering
& Advertising) Rules, 1976 as application for renewal of DML of
firm was received in the Division of Licensing on 16 th September,
2014 which is 62 days delayed from due date of renewal i.e. 17 th
July. The Licensing Division has directed the firm to stop the
production immediately and submit application for afresh grant of
DML on prescribed Form 1 along with all prerequisite as per rules.

5944.
Case No.23
Renewal of Drug Manufacturing License No. 000541 (Formulation)
Show Cause Notice.
5945.
No.F2-9/2006-Lic
Licensing Division has informed vide letter

(Vol-I)
dated
13.03.2015
that
Drug
Manufacturing License (DML No. 000666) (formulation) of M/s

Klifton Pharma Located at Plot # D-2, SITE, Jomshro has been
invalid as per Rule 5(3) of Drugs (Licensing, Registering &
Advertising) Rules, 1976 as application for renewal of DML of firm
was received in the Division of Licensing on 18 th November, 2014
which is 05 months delayed from due date of renewal i.e. 13 th June.
The Licensing Division has directed the firm to stop the production
immediately and submit application for afresh grant of DML on
prescribed Form 1 along with all prerequisite as per rules.
5946.

5948.
559
5949.
Case No.24
Transfer of registration from bulk import to local manufacturing of
registered products.
5950.
Following products of M/s. Genix Pharma Private Limited, Karachi are registered for
bulk import from M/s Vitabiotechs Ltd, England and repacked locally. Now firm has
requested for manufacturing of these registered products at its own facility. Details are as
follows:
5955.
5952. Produ
ct Name
5953.
5954.
5956. Perfect
ial
Capsules
5957. Each
Capsule
contains:
5958. Vitami
n
D
(100IU)
..2.
5mg
5959. Vitami
n
E
.
40mg
5960. Vitami
n
C
....
30mg
5961. Vitami
n
B1
...1
0mg
5962. Vitami
n
B2
.
5mg
5963. Nicotin
5983.
5984.
560
amide
18mg
5964. Vitami
n
B6
20mg
5965. Folic
Acid
.500ug
5966. Vitami
n
B12
9ug
5967. Biotin
..45ug
5968. Pantoth
enic
acid
40mg
5969. Iron
12mg
5970. Magnn
esium
..15mg
5971. Zinc
200ug
5972. Magne
se
.
..2mg
5973. Copper
561
5985.
..
2mg
5974. Silicon
.3mg
5975. Siliniu
m
.100ug
5976. Chromi
mum
.
.500ug
5977. Cystin
.
10mg
5978. Betacar
olene
.
...5mg
5979. PABA
.
30mg
5980. Echina
cea extract
.
195mg
5981. Bordoc
k
extract
.
.80mg
5982.
5986. Diabet
one
Capsules
5987. Each
capsule
contains:
5988. Vitami
n
6008.
6009.
562
A
.70
0ug
5989. Vitami
n
D
..5ug
5990. Vitami
n
E
.
30mg
5991. Vitami
n
B1
...1
5mg
5992. Vitami
n
B2
.
5mg
5993. Niacin
.
45mg
5994. Vitami
n
B6
25mg
5995. Folic
Acid
.500ug
5996. Vitami
n
B12
9ug
5997. Biotin
..200ug
563
6010.
5998. Pantoth
enic
acid
..40m
g
5999. Iron
8mg
6000. Magnn
esium
..100mg
6001. Zinc
15mg
6002. Magne
se
2mg
6003. Copper
..
1mg
6004. Siliniu
m
.100ug
6005. Chromi
mum
gft
..2
00ug
6006. Iodine
.
1000ug
6007.
6011. Visiona
ce
Capsules
6012. Each
capsule
6038.
6039.
564
contains:
6013. Vitami
n
A
.300ug
6014. Betacar
otene
.3mg
6015. Vitami
n
D3
..2.
5ug
6016. Vitami
n
E
..60mg
6017. Vitami
n
B1
.....
.7.6mg
6018. Vitami
n
B2
.
5mg
6019. Vitami
n
C
160mg
6020. Vitami
n
D3
.
2.5uug
6021. Folic
Acid
.250u
565
g
6022. Vitami
n
B6
..2mg
6023. Vitami
n
K1
.
100ug
6024. Vitami
n
B12
4.5ug
6025. Pantoth
enic
acid
...1
0mg
6026. Iron
.
3mg
6027. Magnn
esium
...50
mg
6028. Nicotin
amide
8mg
6029. Bhiofla
vonoids
(Citrus)
.16
mg
6030. Bilberr
y
powdered
566
exract
60mg
6031. Zinc
7.5mg
6032. Magne
se
2mg
6033. Copper
..
1mg
6034. Siliniu
m
.100u
g
6035. Chromi
mum
gft
..5
0ug
6036. Iodine
.100u
g
6037.
6040.
6041. The applicant has submitted following documents:i)
ii)
iii)
Copy of registration letter and renewal status

Form 5
Copy of last inspection report
6042.
6043. The case is placed before Registration Board for consideration.
6044.
567
6045.
Case No.25
6046.
Change of brand name of registered drug.
M/s PharmEvo (Pvt.) Ltd, Karachi has requested for change in brand name of
Adora Tablet to Adora Active Tablet, Reg. No. 076080. Firm has furnished following information to
support their request:
a. Copy of registration letters
b. NOC for CRF clearance
c. An undertaking that the proposed names do not resemble with already registered brands. In case
of resemblance/similarity with already registered drug, the applicant will be liable to change
immediately. Moreover, no case is pending at any forum / court of law regarding this matter
d. Fee @ Rs.20,000/- for the purpose
6047.
6048.
Registration Board in 247th meeting discussed use of suffix extra, fast, long, fort and
advised stake holders to forward their comments.
6049.

6050.
6051.
Case No.26:
Change of formulation - sodium carbonate from inactive to API

6052.
M/s GSK Karachi has informed that due to
global formulation harmonization process they are including

Sodium Carbonate in the API list from Inactive of existing
formulation for following products.
1. Eno Fruit Salt Regular (Reg No. 000180)
2. Eno Fruit Salt Lemon (Reg No. 016868)
3. Eno Fruit Salt Orange (Reg No. 019645)
6053.
6054. Firm has submitted following documents:
Fee @ Rs. 5000/- for each product.

Formulations as per details for label claim along with current and proposed claim.
complete batch formulation containing API and inactive, specification and stability data.
6055.
6057.
6058.
Case No.27 Combo pack Osmolar ORS (Reg. No.0454416) with ZincatOD Syrup (Reg. No.053094) M/s Atco Laboratories, Karachi
568
6059.
6060.
Registration Board in 247th meeting considered
request of M/s Atco Laboratories Ltd, Karachi for provision of

following two registered drugs in one Combo pack as per
following details:6061.
6062.
6063.
6064. Name of
drug(s) &
Composition
6065.
6066.
6067.
6068.
6069.
6078.
6079.
6070. Osmolar
ORS
6071. Each sachet
contains:6072. Sodium
Chloride BP
.1.3g
6073. Potassium
Chloride BP
.0.75g
6074. Sodium
Citrate BP
1.45g
6075. Glucose
Anhydrous
. 6.75g
6076.
6080. Zincat
OD Syrup
6081. Each 5ml
contains:6082. Elemental
Zinc (as Zinc
Sulphate
6083. Monohydra
te USP)
.20mg
6084.
6077.
6085.
6086.
569
6087. Firm has submitted following justifications to support their

request:The reason for making combo pack is that if both products are being used simultaneously
by the patient for management of diarrhea then it will ultimately reduce the use of
antibiotics and intravenous fluids for treatment of diarrhea.
It also helps malnourished children to recover more quickly from diarrhea.
Recent studies suggest that administration of Zinc along with low osmolarity oral
rehydration solution / salts (ORS) can reduce the duration and severity of diarrheal
episodes for up to three months.
According to WHO, Zinc and low osmolarity ORS are critical for the reduction of
diarrhea mortality.
6088.
6089. They have also furnished following documents:6090.
i.
copy of registration letter with last renewals
ii.
two copies of proposed art work of combo pack duly singed by QC & Production
inchange
iii.
Packaging specifications of combo pack
iv. Reference, indicting that the prescribing information is in line with information
approved by the international regulatory authority.
v. copy of valid DML, NOC for CRF
vi.
Undertaking
vii.
Variation fee of Rs.5000/- for the purpose.
6091.
6092. Registration Board deferred the case for presentation by the
firm.
6093.
570
6094. Registration-V
6095. Case No. 28
6096. M/s. Unison Chemical Works, Lahore has requested for
change of toll manufacturer of their following registered
products from M/s. Gobal Phamra, Islamabad to M/s.
McOlson Research Laboratories (Pvt.) Ltd; Sheikhupura:6097.
6098. Nam
e of
Drug(s)
6101. Unib
actum
2gm IV
Injectio
n
6102. Each
vial
contain
s:6103. Cefo
perazol
e (as
sodium
)
.. 1gm
6104. Sulb
actum
(as
sodium
)
.
1gm
6107. Unib
actum
1gm IV
Injectio
n
6105.
6111.
571
6108. Each
vial
contain
s:6109. Cefo
perazol
e (as
sodium
)
..
500mg
6110. Sulb
actum
(as
sodium
)
.
500mg
6113. Ucef
ore
1gm IV
Injectio
n
6114. Each
vial
contain
s:6115. Cefe
pime
(as
HCl)
1gm
6118. Ucef
ore
1gm IV
Injectio
n
6116.
6121.
572
6119. Each
vial
contain
s:6120. Cefe
pime
(as
HCl)
1gm
6122.
6123. The management of the firm has submitted relevant
documents as per form -5 alongwith fee of Rs. 50,000/
6124.
6125. Case No. 29:
6126. M/s. Wilshire Laboratories (Pvt.) Ltd; Lahore had requested for correction in
registration letter as under:6128.
Na
6129.
N
6132.
Z
6136.
Z
6133.
Ea
6137.
E
6134.
Di
6138.
D
6135.
(
6139.
(
6141.
6142.
It is submitted that the standard formulation of
Diclofenac Sodium Injection is 25mg/ml or 75mg/3ml and

573
all other brands are available in the same strength. If approved

we may correct the formulation/label claim of Zwitter
Injection 25mg as 25mg/ml or 75mg/3ml as approved by the
Registration Board in its meeting No. 236. The minutes of
meeting also reveals that firm had applied correct formulation.
6143.
6144.
6145. Case No. 30.
6146.
6147. M/s. Titlis Pharma, Lahore has requested to cancel the
registration of following product from M/s. Highnoon Labs,
Lahore and register in the name of their firm:6149. Name of
Drug(s)
6152. Gargalen
e Liquid
6153. Contains:
6154. Phenol
0.1% w/v
6155. Sodium
Phenolate
. 1% w/v
6156. Menthol
.
0.035%w/v
6157. Thymol
0.075% w/v
6158. Glycerine
6159.
574

10% w/v
i.
ii.
iii.
iv.
v.
6160.
6161. The firm has submitted following documents alongwith
shortcomings for this purpose:Application on Form-5.
Fee of Rs. 20000/- for this purpose.
Copy of initial letter of registration and renewal status.
NOC from M/s. Highnoon Labs; Lahore.
Approval of section by Central Licensing Board.
6162.
6164.
6165. Case No.31.
6166.
6167. M/s. Searle IV Solutions (Pvt.) Ltd; Lahore was requested
for transfer of registration of following products from M/s.
The Searle Company Ltd; Karachi to their name of the firm.
The Registration Board in its 246th meeting considered the
case and decided to cancel the registration of following from
the name of M/s. the Searle Company Karachi and registered
in the name of M/s. Searle IV Solutions (Pvt.) Ltd; Lahore:6168.
6169. Na
me of
Drug(
s)
6172. M
etron
zine
Inject
ion
6173. Ea
ch
100
ml
contai
ns:6174. M
etroni
dazol
e
6175.
575

.
. 500
mg
6177. Va
ptor
20
mg
Table
ts
6178. Ea
ch
tablet
contai
ns:6179. Ro
suvas
tatin
(as
Calsi
um)
.
20
mg
6182. Se
arl-
0.5
mcg
Table
ts
6183. Ea
ch
tablet
contai
ns:6184. Al
facalc
idol
0.5
mcg
6187. Rh
ulef
20
mg
6180.
6185.
6190.
576
Table
ts
6188. Ea
ch
film
coate
d
tablet
contai
ns:6189. Le
fluno
mide
.
20
mg
6192. Gr
avinat
e
Inject
ion
6193. Ea
ch ml
contai
ns:6194. Di
menh
ydrin
ate
50
mg
6197. Se
arl-
1
mcg
Table
t
6198. Ea
ch
tablet
contai
ns:-
6195.
6200.
577
6199. Al
facalc
idol
.. 1
mcg
6202. Pe
ditral
Liqui
d
6203. Ea
ch 5
ml
contai
ns:6204. So
dium
Chlor
ide
.....
.
17.50
mg
6205. Po
tassiu
m
Chlor
ide
7.50
mg
6206. Tri
sodiu
m
Citrat
e
6207. Di
hydra
te
6210.
578
..
14.5
mg
6208. De
xtrose
100.0
0 mg
6209. (Fl
avour
:
Oran
ge)
6212. Pe
ditral
Liqui
d
6213. Ea
ch 5
ml
contai
ns:6214. So
dium
Chlor
ide
.....
.
17.50
mg
6215. Po
tassiu
m
Chlor
ide
7.50
mg
6216. Tri
sodiu
m
6220.
579
Citrat
e
6217. Di
hydra
te
..
14.5
mg
6218. De
xtrose
100.0
0 mg
6219. (Fl
avour
:
Regul
ar)
6222. Rh
ulef
10
mg
Table
ts
6223. Ea
ch
film
tablet
contai
ns:6224. Le
fluno
mide
.
10
mg
6227. Se
arl-
6225.
6230.
580
0.25
mcg
Table
t
6228. Ea
ch
tablet
contai
ns:6229. Al
facalc
idol
.
. 0.25
mcg
6232. Co
Olest
a
Table
t
6233. Ea
ch
tablet
contai
ns:6234. Ol
mesar
tan
.
.. 20
mg
6235. Hy
droch
loroth
iazide
..
12.5
mg
6236.
6239. Va
6237.
6243.
581
ptor
Table
ts
6240. Ea
ch
tablet
contai
ns:6241. Ro
suvas
tatine
(as
Calci
um)
.
.
5
mg
6242.
6245. Ol
esta
20
mg
Table
t
6246. Ea
ch
tablet
contai
ns:6247. Ol
mesar
tan
Medo
xomil
20
mg
6248.
6251. Ol
esta
40
mg
Table
t
6252. Ea
ch
6249.
6255.
582
tablet
contai
ns:6253. Ol
mesar
tan
Medo
xomil
40
mg
6254.
6257. Pe
ditral
Liqui
d
6258. Ea
ch 5
ml
contai
ns:6259. So
dium
Chlor
ide
17.50
mg
6260. Po
tassiu
m
Chlor
ide
.
. 7.50
mg
6261. Tri
sodiu
m
Citrat
e
6262. Di
hydra
6266.
583
te
.
. 14.5
mg
6263. De
xtrose
.
..
100.0
0 mg
6264. (Fl
avour
:
Bana
na)
6265.
6268. Pe
ditral
Liqui
d
6269. Ea
ch 5
ml
contai
ns:6270. So
dium
Chlor
ide
17.50
mg
6271. Po
tassiu
m
Chlor
ide
6276.
584
. 7.50
mg
6272. Tri
sodiu
m
Citrat
e
6273. Di
hydra
te
.
. 14.5
mg
6274. De
xtrose
.
..
100.0
0 mg
6275. (Fl
avour
:
Bubbl
e
gum)
6278. Co
Olest
a
Table
t
6279. Ea
ch
tablet
contai
ns:6280. Ol
mesar
tan
6282.
585
.
.. 40
mg
6281. Hy
droch
loroth
iazide
..
12.5
mg
6284. Si
mbex
Table
ts
6285. Ea
ch
tablet
contai
ns:6286. Si
mvast
atin
.
10
mg
6287. Ez
etimi
be
10
mg
6290. Va
ptor
Table
t
6291. Ea
ch
tablet
contai
6288.
6293.
586
ns:6292. Ro
suvas
tatin
(as
Calci
um)
.
10
mg
6295. Si
mbex
Table
ts
6296. Ea
ch
tablet
contai
ns:6297. Si
mvast
atin
.
20
mg
6298. Ez
etimi
be
10
mg
6301. Rh
ulef
100
mg
Table
ts
6302. Ea
ch
tablet
6299.
6304.
587
contai
ns:6303. Le
fluno
mide
100
mg
6305.
6306. Meanwhile, The Managing Directors of M/s. The Searle
Company Karachi and Chief Executive of M/s. Searle IV
Solutions have submitted a joint request that they have
decided to keep all the above registrations in the name of M/s.
The Searle Company Ltd; Karachi and withdraw for transferof
their products.
6307. It is submitted that the matter has been discussed in 246 th
meeting of Registration Board and approval letter has not
been issued yet due to the above reason.
6308.
6310.
Submitted forconsideration of Registration Board.
6309.
Case No.32. CANCELLATION OF REGISTRATION AND
REGISTRATION OF DRUG(S) IN NEW NAME OF THE FIRM
WITHIN SAME SITE.
6311. M/s. Araf (Pvt.) Ltd; Lahore has requested for cancellation of registration from
their previous name of the firm i.e M/s. Remedy Pharmaceuticals (Pvt.) Ltd; Lahore and register
in their new name of the firm i.e M/s. Araf (Pvt.) Ltd; Lahore. The name of the firm was
changed from M/s. Remedy Pharmaceuticals (Pvt.) Ltd; Lahore to i.e M/s. Araf (Pvt.) Ltd;
Lahore within the same site:6313. N
ame
of
6315.
6316.
588
Drug
(s)
6318. X
encit
Table
t.
Each
tablet
Cont
ains:Cetiri
zine
Dihy
droch
lorid
e
10mg
6319. (
Man
ufact
urer
s
Spec
s)
6320.
6327. Fa
max
40mg
Table
t
Each
tablet
Cont
ains:Famo
tidine
..
6321.
6322.
6323.
6324.
6330.
6331.
589
40mg
6328. (U
SP
Spec
s)
6329.
6334. A
nurbi
Table
t
Each
tablet
Cont
ains:Flurb
iprof
en
.10
0mg
6335. (B
.P
Spec
s)
6340. G
esino
r
Table
t
Each
tablet
Cont
ains:Parac
etam
ol
.45
0mg
Orph
enadr
6336.
6337.
6343.
6344.
590
ine
Citrat
e
35mg
6341. (
Man
ufact
urer
s
Spec
s)
6342.
6347. Te
rbife
n
250m
g
Table
ts
6348. Ea
ch
tablet
conta
ins:6349. Te
rbina
fine
.25
0mg
6350. (
Man
ufact
urer
s
Spec
s)
6351.
6358. Lo
tadin
e
10mg
Table
t
6359. Ea
6352.
6353.
6354.
6355.
6362.
6363.
591
ch
film
coate
d
tablet
conta
ins:6360. Lo
ratidi
ne
.
.
10mg
6361. (U
SP
Spec
s)
6366. Re
viron
Table
t
75mg
6367. Ea
ch
film
coate
d
tablet
conta
ins:6368. Di
clofe
nac
Potas
sium
.
.
75mg
6369. (B
P
6370.
6371.
6372.
6373.
592
Spec
s)
6376. Re
viron
50mg
Table
t
6377. Ea
ch
film
coate
d
tablet
conta
ins:6378. Di
clofe
nac
Potas
sium
50mg
6379. (B
P
Spec
s)
6384. Re
dimi
n
500m
cg
Table
t
6385. Ea
ch
film
coate
d
tablet
conta
6380.
6381.
6388.
6389.
6390.
6391.
593
ins:6386. M
ecob
alami
n
.
.
500m
cg
6387.
6394. Re
motr
al SR
Table
t
Each
sustai
ned
relea
se
tablet
conta
ins :6395. Di
clofe
nac
Sodi
um
..1
00mg
6396. (U
SP
Spec
s)
6397.
6398.
6399.
6400.
6402.
6403. The management of the firm has deposited fee of Rs.
20,000/- for each product. They have provided approval of
title of the firm from Licensing Section. They have also
594
submitted applications on
documents for this purpose.
Form-5
alongwith
relevant
6404. Submitted for consideration of RegistrationBoard.

6405.
6406. Case No.33:
6407. The Registration Board in its 245th meeting deferred the
following products of M/s. Shrooq Pharma, Lahore for TOC
analyzer & liquid particle counter :6408.
6409.
Na
6410.
6411.
6412.
6414.
Mo
6420.
6423.
6428.
6421.
6424.
595
6422.
6425.
6415.
Inje
6426.
6416.
Eac
6427.
6417.
Dicl
596
6418.
(NS
6419.
(Ma
597
6430.
D-
6436.
6439.
6444.
6437.
6431.
Inje
6440.
6438.
6441.
6432.
Eac
6442.
6433.
Cho
6443.
598
6434.
(Vit
6435.
(B.P
6446.
Rise
6452.
6455.
6461.
6453.
6456.
6457.
6447.
Inje
6454.
6458.
599
6448.
Eac
6459.
6449.
Iron
6460.
600
6450.
(Ant
6451.
(US
601
6463.
Nal
6469.
6472.
6476.
6470.
6464.
Inje
6471.
6473.
6474.
6465.
Eac
6475.
6466.
Nal
602
6467.
(Opi
603
6468.
(Ma
6478.
Flud
6484.
6487.
6492.
6485.
6488.
6479.
Inje
6486.
6489.
6490.
6480.
Eac
604
6491.
6481.
Flup
605
6482.
(Ant
6483.
(B.P
6494.
Ligc
6500.
6503.
6507.
6501.
6495.
Inje
6504.
6502.
6505.
6496.
Eac
6506.
606
6497.
Lig
6498.
(Lo
607
6499.
(US
6509.
Life
6515.
6518.
6522.
6516.
6519.
6510.
Inje
6517.
6520.
6511.
Eac
6521.
608
6512.
Wat
6513.
(Wa
609
6514.
(US
6524.
Hire
6530.
6533.
6537.
6531.
6532.
6534.
6525.
Inje
6535.
6526.
Eac
6536.
610
6527.
Mec
6528.
(Act
611
6529.
(Ma
612
6539.
Para
6545.
6548.
6553.
6546.
6549.
6547.
6550.
6540.
Infu
6551.
6541.
Eac
6552.
6542.
Para
613
6543.
(Mil
6544.
(Ma
614
6555.
Lefe
6561.
6564.
6569.
6562.
6565.
6566.
6563.
6556.
Infu
6567.
6557.
Eac
6568.
6558.
Lev
615
6559.
(Qui
616
6560.
(Ma
6571.
M.C
6577.
6580.
6585.
6578.
6581.
6582.
6579.
6572.
Infu
6583.
6573.
Eac
6584.
617
6574.
Cipr
6575.
(Qui
618
6576.
(B.P
6587.
Coz
6593.
6596.
6602.
6594.
6597.
6598.
6588.
Infu
6595.
6599.
6600.
6589.
Eac
6601.
619
6590.
Fluc
6591.
(Ant
6592.
(Ma
620
6604.
Ken
6610.
6613.
6617.
6611.
6614.
6612.
6605.
Infu
6615.
6606.
Eac
6616.
621
6607.
Oflo
6608.
(Qui
622
6609.
(Ma
6619.
Met
6625.
6628.
6633.
6626.
6629.
6630.
6627.
6620.
Infu
6631.
623
6621.
Eac
6632.
6622.
Met
6623.
624
(Am
6624.
(B.P
6635.
Lins
6640.
6643.
6648.
6641.
6644.
6645.
6642.
6636.
Infu
6646.
6637.
Eac
6647.
625
6638.
Line
6639.
(Ox
626
6649.
6650. The area FID has confirmed that the firm has installed TOC
analyzer and particle counter and both are operational. Now
the firm has requested to grant them registration of above
mentioned products.
6651. Submittedforconsideration of Registration Board.
i.
ii.
iii.
6652. Case No.34:

6653.
6654.
The Registration Board in its 241st meeting deferred
the following product of M/s. Neutro Pharma, Lahore for
opinion by following experts:6655.
Head. Department of ICU, MH, Rawalpindi.
Head. Department of Anesthesia, PIMS, Islamabad.
Brig. Dr.Muhammad Aslam khan
6656.
6657.
6662.
6658.
6659.
6663.
6664.
N Pack
6667.
1. 6672.
6677.
6660.
6661.
6666.
Size
MRPRs.
6668.
6669. 6670.
6674.
6673.
6675.
N
2ml
5500/6681.
6682.
Ea
per
6678.
6671.
6676.
6683.
6665.
D
6679.
6684.
6685.
The firm has the submitted that the third expert nominated by the Board is Head of Department
of ICU, Rawalpindi , is also Brig. Dr. Muhammad Aslam Khan who has already provided expert
opinion and both the experts has commented as under:6686.
6687.
Comments
Nam
627
6688.1. Said drug is already in practice worldwide and few centers in

Prof. Pakistan.
2. On page 14 there is typographical mistake showing that said
firm not checked before submission on serial No. 1. It is not
Lidocaine but Dexmedatomidine HCl as active ingredient .
Calculation from gram to microgram may be revisited
according to their statement of manufacturing step (25L to 206
litres).
3. Said firm has not mentioned about the country of import for
raw material and how quality of that material will be
maintained during transport to Pakistan.
4. Are they going to check the efficacy drug in animallab?
6689. 6690. Dexmedetomidine is a highly selective, centrally

Brig.
acting alpha-2-agonist with anxiolytic, sedative, and some analgesic
effects. It has no deleterious effects on respiratory drive. According to
the approved product information from the United States Food and
Drug Administration (FDA), dexmedetomidine is indicated for initial
sedation of mechanically ventilated patients for up to 24 hours.
6691. Its indications include sedation of initially-intubated
and medicinally-ventilated patients during treatment in an intensive
care setting. Procedural sedation prior to and/ or during awake fiber
optic intubation; sedation prior to and/ or during surgical or other
procedures of nonintubated patients.
6692. Dexmedetomidine may be less likely to cause delirium,
than sedative agents in the ICU. It will be a useful addition in the
armamentarium of the intensivist unit and anesthetists.
6693. In view of the above I recommend this drug for
registration at an affordable price.
6694.
628
6696.
6697. Case No.35
6698.
6699. M/s. The Schazoo Pharmaceutical Laboratories (Pvt.) Ltd;
Sheikhupura has informed that during shifting their files the
original registration of following product has been lost and
they have lodged proper FIR for this:6700.
6702. Name
s of
Drug(s)
with
formulat
ion
6705. Veer
Tablet
6706. Each
film
coated
tablet
contains:
6707. Entec
avir as
monohy
drate
.. 1mg
6708.
6709.
6710. The management of the firm has deposited fee of Rs.
5000/- for this purpose and also furnished copy of FIR attested
by police station Gulberg Lahore. They have requested to
issue duplicate registration letter for above mentioned product.
6711.
6712. Submitted forconsideration of Registration Board.
6713.
629
6714.
6715. Case No.36.
6716.
6717. The Registration Board deferred the following products of
M/s. Searle IV Solutions (Pvt.) Ltd; Lahore for PSI by
Director DTL, Peshawar, Area FID and ADC:6718.
1.
6719. B
rand
Nam
e
6720. D
osag
e
For
m
6721. C
omp
ositi
on
6722. (p
har
mac
ologi
cal
Gro
up)
6723.
6724. Fi
nish
ed
prod
uct
spec
ifica
tion
6739. IS
O
Mac
IV
6740. In
jecti
on
6741. E
ach
100
6725.
6726.
6731.
6736.
6737.
6727.
6728.
6729.
6730.
6732.
6733.
6734.
6735.
6764.
6765.
6766.
6769.
6772.
6770.
6767.
6768.
6771.
630
ml
cont
ains:
6742. (T
otal
amin
o
acids
..1
0.64
1g)
2.
6743. L-Isoleucine..0.56g
6744. L-Leucine..1.25g
6745. L-Lysine HCl..1.10g
6746. L-Methionine..0.35g
6747. L-phenylalanine.0.935 g
6748. L-Threonine.0.65 g
6749. L-Tryptophan...0.13 g
6750. L-valine.0.45g
6751. L-Alanine0.62g
6752. L-Arginine HCl..0.955g
6753. L-Aspartic acid0.38g
6754. L-Cysteine HCl (H2O)
.0.145g
6755. L-Glutamic acid..0.65g
6756. L-Histidine HCl(H2O)
.0.811g
6757. L-Proline..0.33g
6758. L-Serine.0.22g
6759. L-Tyrosine0.035g
6760. Amino acetic acid..1.07g
6761. (Amino acids)
6762. (Manufacturers Spec.s)
6763.
6773. A
mino
Rib
6774. I
V
Injec
tion
6775. E
ach
1000
ml
6808.
6809.
6810.
6813.
6816.
6814.
6811.
6812.
6815.
631
cont
ains:
-
3.
6776. (Amino acids (L-form)

..50.0g)
6777. L-Isoleucine..3.20g
6778. L-Leucine..2.40g
6779. L-Lysine HCl..2.50g
6780. L-Methionine..3.00g
6781. L-Phenylalanine.4.00g
6782. L-Threonine..2.00g
6783. L-tryptophan1.00g
6784. L-Valine..3.20g
6785. L-Alanine..6.00g
6786. L-Arginine HCl2.66 g
6787. L-Arginine.4.00g
6788. L-Histidine HCl .H2O..1.35g
6789. L-Proline.2.00 g
6790. Glycine (amino acetic acid)
.14.0g
6791. D-Sorbitol.100.00g
6792. Vitamin C..400.00mg
6793. Inositol..500mg
6794. Nicotinamide.60.00mg
6795. Pyridoxine HCl..40.00mg
6796. Riboflavin sodium
phosphate.2.50mg
6797. Water for injection .q.s
6798. Electrolytes (mEq/L)
6799. Sodium..35
6800. Potassium..25
6801. Magnesium..5
6802. Acetate.35
6803. Malate.22
6804. Chloride..38
6805. (Amino acids, vitamins &
sorbitol)
6806. (Manufacturers Spec.s)
6807.
6817. V
D3
6818. In
jecti
on
6819. E
ach
6823.
6824.
6825.
6827.
6830.
6828.
6826.
6829.
632
ml
cont
ains:
6820. C
hole
calci
ferol
.5.
0mg
6821. (
Vita
min
D)
6822. (
USP
Spec
.s)
6831.
6832. The panel comprising Dr. Khalid Khan, Director DTL,
Peshawar, Mr. Asim Rauf, FID Lahore and Miss Sara
Mahreen ADC, Lahore has recommended to registration the
above mentioned products of M/s. Searle IV Solution (Pvt.)
Ltd; (Formerly Mac & Rains Pharmaceuticals) 1.5KM, Manga
Raiwind Road, Manga Mandi, Lahore.
6833.
please.
6835.
6836. Case No. 37.
6837.
6838. The Registration Board in its 238th deferred the following
product of M/S CCL Pharma Lahore
for submission of
application on form-5D and remaining fee and confirmation

for approval by USFDA, EMA, regulatory body of Japan or
Australia and Expert opinion. Case will be then placed before
Registration Board being a new molecule:6839.
6840.
6841.
6842.
Na
6843.
6844.
6846.
6845.
633
1.
6847.
Co
6852.
6853.
6855.
6854.
6848.
Ea
6856.
6849.
Iro
6850.
(Ir
6851.
6857.
6858.
634
6859.
6860.
6861. The firm has submitted form-5D and along with relevant
fee of Rs. 50,000/- for this purpose. The dossier of the firm
is evaluated by the Evaluation Cell. And the firm has
submitted the availability in TGA, Australia
6862.
6863. Submitted for consideration of Registration Board for being
a new molecule for nomination of expert.
6864.
635
6865. RRR Section

6866. Case No.38: M/s. Global Veterinary & Technical Services
(Pvt.) Ltd; Multan has applied for renewal of registration
following drugs .The detail of renewal status is mentioned
below:6868.
6869.
Na
6870.
6871.
6874.
6875.
En
6876.
6877.
6880.
6881.
En
6886.
6887.
Col
6892.
6893.
Co
6878.
6897.
6898. M/S Global Veterinary &Technical Services (Pvt) Ltd.,
Multan has submitted documents that they haveapplied for the
Renewal /change of manufacturer name in R-1 Section.
6899. Registration-I section was requested in the matter to verify
the above said application. The Reg-I section has informed
that the request of the firm was received in R-I section but
decision was not occurred due to GMP compliance of the
manufacturing facility of the firm in Korea, later on the issue
of GMP resolved but approval of change of name was still not
done. He has proposed that to place the matter before the
636
Registration Board for further deliberation and decision on the

matter please.
6900. Submitted for consideration of Registration Board please.
6901.
6902. Case No.39:
6903.
The name of M/s. Fakma Pharma, Lahore was
changed from M/s. Fakma Pharma, Lahore to M/s.

Pharmawise Labs (Pvt.) Ltd; Lahore in year 2000 on their
request. Subsequently, the firm requested that either change all
registration letters with new name of their firm or issue a letter
to reflect the said change in each of the registration letter,
however, they did not deposit any fee for this purpose. The
case was placed before the registration Board in 164th meeting
of held on 30-7-2001 wherein Registration Board had decided
the case as under).
6904. The request of the firm was not acceded to and the was
directed to deposit the requisite fee of Rs. 8000/- for each
product for transfer of registration in the new name
6905. It is submitted that as per practice in vogue, in case a firm
changes their name/ title, such a firm apply for transfer of
registration form previous name to new name with full
registration fee. However, the owner of the firm has the view
that there is no provision in law for transfer of registration
with full fee on same premises. Further, the firm is also of the
opinion that the change of the name of company from M/s.
Fakma Pharma, Lahore to M/s. Pharmawise labs (Pvt) Ltd:
Lahore on Drug Manufacturing License is deemed to be valid
for all purposes contingent to their Drug Manufacturing
License.
637
6906. The above position was presented before registration board

in its 246th meeting held on 10-11th December, 2014 for
guidance/ orders in the matter. Registration Board decided to
seek opinion of Legal Affairs, Division, DRAP in the matter.
6907. The opinion of legal division is as under:6908. Facts of the case of M/s. Breez PharmaICI were different
the facts of the case of M/s. Pharmawise therefore, the two
cases are not be taken on the same analogy and equated.
6909. Advise of the Law Division to make the respective rules
exploit and clear may be proceeded. In the meanwhile the
registration Board may decide the matter as per applied rules.
6910. Submitted for the consideration of Registration Board.
6911.
638
6912. Item No.IV: Cases referred by Biological Evaluation &

Research Division.
6913. Case No.01 Expert pool for the evaluation of Bioloigical Drugs.
Registration Board in its 248th Meeting deliberated on
6914.
the proceedings of ECBD and discussed that 500 registration

applications of biological drugs are pending, including applications
of public health importance. The Board decided that in future these
applications shall be scrutinized/ evaluated by Biological Division
itself, and if opinion is required, it shall be taken from the experts of
relevant field. The Board advised Biological Division to prepare a
list of experts of biological field for consideration in its forthcoming
meeting.
6915. Further, available list of experts including the nominees from the
Higher Education Commission of Pakistan are placed below for the
board.
6916. Human Biologicals:
6917.
6918.
Name
a
n
d
D
es
ig
n
at
io
n
of
th
e
m
e
m
b
er
6919. Position/
Expertise
6920.
639
1.
2.
6921.
Dr.
A
a
m
er
I
k
ra
m
6922.
Cons
ul
ta
nt
,
M
ic
r
o
bi
ol
o
gi
st
,
A
F
I
P,
R
a
w
al
pi
n
di
.
6923.
6924. Ph.D.
(Microbiology)
6925. MBBS
6927.
Dr.
A
bi
d
A
6930. Meritorious
Professor
&
D.G. AQ Khan
Institute
of
Biotechnology
&
Genetic
6926.
640
z
h
ar
6928.
PhD
M
ol
e
c
ul
ar
M
e
di
ci
n
e
(
A
u
st
ra
li
a)
a
n
d
M
.S
c
B
io
C
h
e
m
is
tr
y.
6929.
3.
6932.
Dr.
R
o
m
Engineering
University of
Karachi,
Karachi.
6931.
6935. Ph.D Bio

Chemistry UK
6936. B.Sc
Chemistry
Peshawar
641
e
n
a
Q
a
zi
6933.
Shau
k
at
K
h
a
n
u
m
M
e
m
o
ri
al
C
a
n
s
er
H
o
s
pi
ta
l
&
R
e
s
e
ar
c
h
C
e
nt
re
,
University
642
L
a
h
o
re
.
6934.
4.
5.
6937.
Dr.
K
h
al
id
S
a
e
e
d
B
u
k
h
ar
i
6938.
B.
P
h
ar
m
a
c
y
L
a
h
o
re
.
6939.
6940. Country
Advisor
(Medicine),
WHO country
office,
Park
Road,
Chak
Shahzad,
Islamabad.
6943.
Dr.
A
z
6947. Hamdard
Institute of
Pharmaceutical
Sciences,
6941. M. Phil
Clinical
Pharmacy
6942.
643
h
ar
H
u
ss
ai
n
6944.
Profe
ss
or
,
D
e
a
n
&
D
ir
e
ct
o
r
H
a
m
d
ar
d
I
n
st
it
ut
e
o
f
P
h
ar
m
a
c
e
ut
ic
Islamabad.
644
al
S
ci
e
n
c
e
s,
H
a
m
d
ar
d
U
ni
v
er
si
ty
,
Is
la
m
a
b
a
d
6945.
Ph.D.
(
P
h
ar
m
a
c
y
P
ra
ct
ic
e)
,
P
e
645
n
a
n
g,
M
al
a
y
si
a
6946.
Mast
er
o
f
P
h
ar
m
a
c
y
(
C
li
ni
c
al
P
h
ar
m
a
c
y
)
U
ni
v
er
si
ty
S
ci
e
n
646
6.
7.
c
e
s
M
al
a
y
si
a,
P
e
n
a
n
g,
M
al
a
y
si
a.
6948.
Dr.
Ij
a
z
G
h
a
ni
6949.
MBB
S,
F
C
P
S
6950.
(Viro
lo
gi
st
)
6953.
Dr.
I
6951. Armed
Forces Institute
of Pathology
6952. (HEC
nominee)
6957. Professorof
Pathology &
chairman
647
k
ra
m
D
in
6954.
MBB
S,
M
p
hi
l
6955.
(Bact
er
io
lo
gi
st
)
6956.
8.
6959.
Jawa
d
A
h
m
e
d
6960.
FCP
P
F
el
lo
w
C
ol
le
g
Department of
Pathology,Liaqu
at
University of
Medical &
Health Sciences
Jamshoro
6958. (HEC
nominee)
6963. Professor of
Microbiology /
Director,
Institute
of
Basic Medical
Sciences,
Khyber
Medical
University,
Peshawar,
Khyber
Pakhtunkhwa,
Pakistan.
6964. (HEC
nominee)
6965.
648
e
o
f
P
at
h
ol
o
gi
st
s,
P
a
ki
st
a
n
(
h
o
n
o
ra
r
y
)
6961.
PhD,
D
e
p
ar
t
m
e
nt
o
f
M
ic
r
o
bi
ol
o
g
649
y,
U
ni
v
er
si
ty
o
f
L
e
e
d
s,
L
e
e
d
s,
U
K
6962.
9.
6966.
Talat
P
a
nj
w
a
ni
6967.
Phd
in
C
h
e
m
is
tr
y
6968. Dr.
Panjwani
Center
for
Molecular
Medicine and
Drug Research,
International
Center
for
Chemical and
Biological
Sciences
6969. (HEC
Nominee)
10.
6970.
Peter
Jo
h
n,
6973. Principal &

Dean,
6974. Atta-UrRahman School
650
6971.
M.Sc,
M
.P
hi
l,
P
h
D
,
P
os
t
D
o
c.
of Applied
Biosciences
6975. National
University of
Sciences &
Technology
(NUST), Sector
H-12, Islamabad
6976. (HEC
Nominee)
6972.
11.
6977.
Dr.
S
h
a
hi
d
B
ai
g
6978.
Phd
in
H
u
m
a
n
M
ol
ec
ul
ar
G
6979. Professor,
Deputy Chief
Scientist, Head
Health
Biotechnology
Division,
Group Leader
6980. Human
Molecular
Genetics
Laboratory,
6981. National
Institute for
Biotechnology
and Genetic
Engineering
(NIBGE)
6982. (HEC
Nominee)
651
e
n
et
ic
s
12.
6983.
Ali
M
u
h
a
m
m
a
d
W
ar
y
a
h
6985. Assistant
Professor &
Incharge,
Molecular
Biology
6986. Department
,LUMHS,
Jamshoro
6987. (HEC
Nominee)
6984.
Phd
M
ol
ec
ul
ar
B
io
lo
g
y
13.
6988.
Abdul
B
as
it
K
h
a
n
6990. Senior
Scientific
Officer
6991. PCSIR
Laboratories
Complex, Off
University Road,
Karachi-75280
652
14.
6989.
Phd
in
M
ic
ro
bi
ol
o
g
y
A
us
tri
a
6992. (HEC
Nominee)
6993.
Tahir
S
ar
w
ar
6994. Assistant
Professor
6995. Institute of
Basic Medical
Sciences
(IBMS)
6996. Khyber
Medical
University
(KMU),
Peshawar
6997. (HEC
Nominee)
15.
6998.
Dr.
S
y
e
d
H
as
n
ai
n
A
li
6999. Professor
7000. Department
of Medicine
7001. The
Aga
Khan
University,Karac
hi, Pakistan
7002. (HEC
Nominee)
653
S
h
a
h
16.
7003.
Syed
M
u
h
a
m
m
a
d
Z
a
hi
d
A
za
m
7004. Associate
Professor
Gastroenterolog
y
7005. Head of
Medical UnitV/National
Institute of Liver
& GI Diseases
7006. Dow
International
Medical College
7007. Dow
University of
Health Sciences
(DUHS),
Karachi.
7008. (HEC
Nominee)
17.
7009.
Tahir
S
ul
ta
n
S
h
a
m
s
7010. Consultant
Hematologist
BMT Physician
7011. National
Institute of
Blood Disease &
Bone Marrow
Transplantation,
ST- 2/A, Block17,Sir Shah
Sulaiman Road,
Gulshan e Iqbal,
Karachi
7012. (HEC
Nominee)
654
18.
19.
20.
21.
7013.
Dr.
S
a
m
in
a
T
uf
ai
l
7014. Consultant
Hematologist
and head of
Pathology
Department
PAEC General
Hospital,
Islamabad
7016.
Dr
.
A
zi
z
ul
H
as
a
n
A
a
m
ir
7017. Professor
7021.
Dr.
Ib
ra
r
A
h
m
a
d
7022. Senior
Registrar
7025.
Prof.
D
r.
S
7026. Dean/Profess
or
7015. (HEC
Nominee)
7018. Department
of Diabetes and
Endocrinology
postgraduate
medical institute
7019. Hayatabad
medical
complex,
Peshawar,
Pakistan
7020. (HEC
Nominee)
7023. Diabetes and

Endocrinology
unit Lady
Reading
Hospital
Peshawar
7024. (HEC
Nominee)
7027. Faculty of
Pharmacy
655
aj
id
B
as
hi
r
7028. University of
Sargodha,
SargodhaPakistan
7029. (HEC
Nominee)
22.
23.
7030.
Maj
G
e
n
Pr
of
D
r
A
b
d
ul
K
h
al
iq
N
a
v
ee
d
7031. Dean Riphah

Academy Of
Research &
Education
7034.
Dr.
A
b
d
ul
H
a
m
ee
d
7035. Principal
Scientific
Officer
(Associate
Professor)
7032. & Prof /

Head of
Department of
Biochemistry,
Islamic
International
Medical
College, AlMizan IIMCT
Complex, Old
Supreme Court
Building, 274Peshawar Road,
Rawalpindi
Pakistan
7033. (HEC
Nominee)
7036. Institute of
Biomedical and
Genetic
Engineering
(IBGE),24Mauve Area, G9/1,Islamabad,
656
Pakistan.
7037. (HEC
Nominee)
24.
7038.
Mazh
ar
Iq
b
al
7039. Associate
Professor,
7040. Pakistan
Institute of
Engineering &
Applied
Sciences
(PIEAS),
Islamabad
7041. (HEC
Nominee)
7042.
7043.
7044.
7045. Veterinary Biologicals:
7046.
7047.
Na
7048. Position/
Expertise
7049.
7050.
7051.
Dr
7052.
Pri
7055. National
veterinary
laboratory,
Islamabad.
7053.
Na
7054.
7056.
7057.
Pr
7058.
7060. Ex-Vice
Chancellor,
University
of
UVAS, Lahore.
657
Po
7061.
7059.
7062.
7063.
Dr
7066. Post Doc

Veterinary
Medicines from UK,
7064.
D
7065.
7067.
7068.
Pr
7069.
Po
7073. Dean, Faculty

of
Biosciences,
University
of
Malakand.
7074.
7070.
(S.
7071.
Ph
7072.
7075.
7076.
Dr
7077.
7078.
7079. Head
of
Division
Soil/Environmenta
l Biotechnology &
Genetic
Engineering
(NIBGE), Jhang
Road, Faisalabad.
7080.
7081.
7082.
Pr
7085. Director Institute

of Microbiology,
7083.
Ph
7086. University of
Agriculture,
Faisalabad
658
7088.
7084.
(V
7087. (HEC Nominee)
7089.
M
7092. Associate
Professor/Chairma
n
7093. Department of
Patho-biology
7090.
Ph
7091.
7094. University of
Arid Agriculture,
Rawalpindi
7095. (HEC Nominee)
7096.
7097.
S.
7098.
Ph
7099.
An
7103.
7104.
Dr
7105.
D
7109.
7110.
Dr
7114.
7115.
Dr
7100. Professor/Dean
Faculty of
Sciences
University of Arid
Agriculture
Rawalpindi
7101. (HEC
Nominee)
7102.
7106. Department of
Pharmacology, AlNafees Medical
College, Isra
University,
7107. Islamabad
Campus, Pakistan
7108. (HEC
Nominee)
7111. Associate
Professor and
Chairman
7112. Department of
Clinical Sciences,
Faculty of
Veterinary and
Animal Sciences
(HEC Nominee)
7113. (HEC
Nominee)
7116. Assistant
Professor of
Medicine C.M.S
659
7119.
Department
7117. University of
Veterinary and
Animal SciencesLahore
7118. (HEC
Nominee)
7121. House # 12,
Main, Margalla
Town, Phase II,
Islamabad
7122. (HEC
Nominee)
7120.
Za
7123.
7124. In addition to above experts, the expert from DRAP and

National Institute of Health shall also be invited for evaluation
of registration dossiers having experience in manufacturing/
quality control of human biological drugs. The list of experts
shall be upgraded regularly to incorporate new incomers.
Having
adapted
pool
of
experts
in
biologicals,
recommendation will be forwarded to the Federal Government

for rescinding S.R.O. 1150(I/)/ 2014 and 1151(I)/ 2014. As per
directions of the Board, case to rescind the above mentioned
SROs is being processed through legal procedure.
7125. Case No.02
Policy for renewal of registration of Bioloigical Drugs.
7126. Renewal section (RRR) has referred all the cases for the renewal of Biological
Drugs to the Directorate of Biological drugs. The Directorate of Biological Drugs is already
suffering from lack of human resource to deal the pending registration applications of biological
drugs. Technically it is a good step to perform all the functions connected to biological drugs in
the directorate of Biologicals under the same roof. The renewal process can be used as reevaluation of biological drugs and organizing the data of all the registered biological drugs.
However, under the current working conditions, it is proposed that the renewal section may
continue the renewal of biological drugs as per policy. As soon as the Directorate of Biological
660
drugs is strengthened with human resource and infrastructure, the activity shall be assigned to the
Directorate of Biological Drugs.
7127.
7128.
Matter is placed before the Board for deliberation and decision.
Case No.03 Registraion of drug, namely EYLEA OF M/S. BAYER Pakistan

(Pvt.,) Ltd, Karachi.
7129. The following drug of the firm M/s. Bayer Pakistan (Pvt) Ltd., Karachi was approved
in 240th meeting of Registration Board (Extract from Board Meeting Minutes)

7130.
.No.
7131.
7133.
7132.
7136.
7139.
7142.
7137.
7138.
7143. Regist
7140.
ration Board
7134.
7144.
6.
7145.
7146.
7135.
7152.
7170.
00/
7141.
7171.
7180.
ed
7169.
Rs.120,0
7153.
Approv
7172.
7154.
7147.
7173.
7148.
7155.
7174.
7149.
7156.
7175.
7150.
7157.
7151.
Germany.
7176.
7158.
7177.
7159.
7178.
7160.
7179.
29.03.2013
661
7161.
7162.
7163.
7164.
7165.
7166.
7167.
7168. occlusion
(CRVO).
7181.
7182. The price of the Aflibercept 40 mg/ml was fixed in 12th

DPC, and firm requested for the issuance of the registration
letter. As per CoPP it was noticed that the primary
manufacturing site is Reneneron Pharmaceuticals, New York
USA, while Bayer Pharma AG Berlin Germany is only the
packing and release site. Case of the firm was placed before
the Chairman, Registration Board. The Chairman Registration
Board observed that the mistake in the minutes has happened,
therefore, registration letter with correct manufacturing and
release site as per CoPP and Form 5 A be issued and matter
may be placed in the forthcoming meeting of registration
662
board for validation/ information. Accordingly, registration

letter had been issued.
7183.
Case is placed before the Board for validation and information.
7184.
7185. Case No.04

7186.
Registraion of drug, Benlysta of M/S. GSK, Karachi

The following drug of the firm M/s. GSK., Karachi was approved in 240 th meeting of
Registration Board (Extract from Board Meeting Minutes).

7187.
No.
7188.
7190.
7189.
7193.
7196.
7194.
7195.
7197.
7200. Registration
Board
7198.
7234.
7235.
7240.
7243.
7241.
7244.
7245.
7191.
7201.
7202.
7203.
7204.
7192.
7214.
7215.
7236.
7237.
7238.
7242.
7205.
7206.
7239.
7216.
7199.
07.06.2012
vial
7246.
7247.
7207.
7217.
7208.
7248.
7209.
7218.
7249.
7210.
7250.
7211.
7219.
663
7212.
7251.
7220.
7213.
Pharma, Italy.
7252.
7221.
7253.
7222.
7254.
same.
7223.
7224.
7225.
7226.
7227.
7228.
7229.
664
7230.
7231.
7232.
7255.
7233.
7256.
disease activity.
7268.
7257.
7258.
7259.
7269.
7287.
7288.
7289.
7290.
7291.
7293.
7296.
7294.
7297.
7298.
7295.
7292.
7299.
7260.
7270.
7300.
7261.
7262.
7301.
7271.
7263.
7302.
7264.
7272.
7303.
7265.
7273.
7266.
7304.
7274.
665
7267.
7305.
7275.
7306.
7276.
7307.
7277.
7278.
7279.
7280.
7281.
7282.
7283.
7284.
666
7285.
7286.
7308.
7309. The price of the drug Belimumab (80mg/ml) was fixed in 12th
DPC and firm requested for the issuance of the registration letter.
Following two anomalies were noticed;
7310. i).
Name of drug is recorded as Benlysta Powder for infusion, whereas s per
CoPP, the product is Benlysta powder for concentrate for infusion.
7311. ii).
In CoPP, sterile water for injection is not part of the pack, whereas same is
recorded in the minutes (Column 6 above). The firm has also informed that they have not applied for
diluents with product.
7312.
The case is placed before the Board for correction of name of the product and
correction of diluent approval please.
7313. Case No.5
Registration of drugs of Merixil Pharma, Islamabad.
7314. The following two products of M/s. Merixil pharma were discussed in 248 th Meeting
of Registration Board. Briefly, the products were earlier approved by the Registration Board in its
225th Meeting in the name of M/s. Sami Pharmaceuticals, Karachi, however, the GMP inspection of
the company was not carried out. The firm M/s. Merixil Pharma, Islamabad also applied for the same
products but the applications were not supported with sole company agreement. The firm M/s. Sami
Karachi agreed to withdraw their applications in 246 th Meeting of the Registration Board which was
acceded to. Now the firm M/s. Merixil Pharma, Islamabad has provided their sole company
agreement from Xiamen Amoytop Biotech Co., Ltd., Xiamen, Fujian, P.R. China.
7315.
The Board in its last meeting decided to evaluate the dossiers of the company by the
section.
667
7316.
7323.
7318.
Na
7319.
7324.
M/s
7325.
7322.
7329.
7330.
7331.
7326.
7327.
668
7328.
669
7332.
7333.
M/s
7334.
7338.
7339.
7340.
7335.
670
7336.
7337.
671
7341.
7342.
The dossiers of the products were evaluated by the section.
7343.
The firm has submitted following documents;
672
1) Application on Form 5 A along with all the required information.

2) Fee Rs. 100,000/3) Valid GMP certificate duly notarized (Valid upto 22.11.2017). The GMP certificate also
indicates the firm Xiamen Amoytop Biotech Co., Ltd., Xiamen, Fujian, P.R. China is
manufacturer of Human Interleukin-11 (rHulL-11).
4) CoPP duly notarized indicating that the product is actually on the market in exporting
country.
5) Letter of authorization for five years to Merixil Pharma, Islamabad by M/s. Xiamen Amoytop
Biotech Co., Ltd., Xiamen, Fujian, P.R. China.
7344.
7345.
Additional documents and details submitted by the firm are;
a) Strain related information and construction of engineered strain.

b) Growth characteristics of parent strain, establishment of cell bank system (master bank
and working cell bank) and their characteristics, number of passages and control test of
master cell bank.
c) Quality and stability of working cell bank
d) Protein purification details, molecular data and host cell protein data and certificate for
purification details
e) Flow chart of manufacturing procedure, master formula.
f) Quality monitoring points during production
g) Manufacturing process of concentrated solution with flow chart, validation procedure
including validation of final lot for equipment and process.
h) Product specification, analytical procedure, assay validation, validation report of protein
content in finished product and concentrate.
i) SOP for analytical process with list of SOPs and COA for three batches indicating all the
tests including abnormal toxicity test on mice.
j) Pre-clinical study and clinical studies.
k) Product is on market in China, Peru, Brazil and Paraguay as per firms information.
l) Characterization studies in comparison with Originator Neumega (USA) for Ultraviolet
spectroscopy, peptide mapping, N-terminal 15 amino acid sequence, molecular weight by
SDS page, identification of restriction enzyme mapping of the recombinant plasmid and
mass spectrometry. Comparison satisfactory with Neumega.
m) Identification with immunodot method, Impurities meet the predetermined requirement.
n) A phase II clinical study on interleukin 11 mutein to treat patients with chemotherapy
induced thrombocytopenia in comparison to Neumega on 83 patients with conclusion of
Amoy mIL 11 has equivalent thrombopoeitic activity.
7346.
7347. As per import policy, case is placed before the Board for a decision, as manufacturer is
in China, a Non SRA country.
7348.
7349.
Case No.06.
DEFERRED CASE OF 241ST MEETING FOR POULVAC SE
VACCINE BY M/S. HI-TECH PHARMACEUTICAL, LAHORE.
7350.
The following case was discussed in 246 th Meeting of
Registration Board. Extract from Minutes is as below

673
7351. The following case of M/s. Hi-Tech Pharmaceutical, Lahore was deferred in 241st
Meeting of Drug Registration Board reasons mentioned in the last column below: 7352.
7353.7354. Appl
7355.
7356.
7357.
7358.
Sl.# icant
7359.7360. M/s
6. Hi-Tech
Pharmaceut
ical, Lahore
7361. Man
ufactured
by:
7362. M/s
Pfizer
Animal
Health
(Pfizer Inc),
2000
Rockford
Road,
Charles
City, Iova,
USA
7363.
7374.
7375.
7376.
7364.
7365.
7366.
674
7367.
7368.
675
7369.
7370.
7371.
7372.
7373.
7377.
7378. The firm has submitted application to Animal Husbandry Commissioner Dr. Qurban Ali and
submitted clarification to Director Biological Drugs, DRAP, Islamabad. Clarification submitted to
DRAP and comments of Animal Husbandry Commissioner are tabulated below: 7379.
7380. Clarification submitted by the
7381. Comments of Animal Husbandry Commissioner
firm to DRAP
7382.
676
For inactivation, formalin is added to

the total volume of the bacterial
suspension, not over 1%
Source of formalin brand used holds
37% formaldehyde solution, of this
37% branded formaldehyde stock
solution, maximum upto 1% of
formalin is used in total volume of the
bacterial suspension.
Dose of Poulvac SE is 0.3mL/bird and
each dose contains 0.0006mL i.e.
0.2% of 37% formaldehyde solution.
7383.
7384. Formalin is used to produce inactive bacterial vaccines.
For this purpose, 37% formalindehyde gas is added to water to
produce reagent commonly known as formaline, which is then used
in a very small concentration (as is used in the subject product
Poulvac SE at the rate of 1% to the total volume of bacterial
suspension). Therefore, 37% formaldehyde solution or formalin at
the rate of 1% is part of normal procedure to produce such
inactivated vaccines.
7385.
7386.
7387. Earlier Decision: Registration Board referred the case to Expert
Committee on Biological Drugs (Vet) for its consideration.
7388.
7389.
It is proposed that the case may be decided by the Board in light of comments of Dr. Quban Ali
(Animal Husbandry Commissioner), National Veterinary Laboratories, Islamabad.

7390.
7391.
Case No.07.
Karachi
7392.
EXTENSION OF SHELF LIFE of M/s. Eli Lilly (Private) Limited,
The following cases of firm M/s Eli Lilly Karachi are submitted for the extension of
shelf life details as under:7396.
7404.
7398.
7399.
7400.
7405.
7406.
7409.
7416.
7417.
677
7425.
7426.
7434.
7435.
7443.
7444.
7454.
7455.
7461.
7463.
7464.
7470.
7472.
7473.
7479.
7481.
7482.
7488.
7489.
The firm has submitted following documents.
1. Fee Rs. 5000/- for each application.

2. CoPP duly legalized/ notarized from country of origin. Shelf life indicated as three (3) years in the
attachment to CoPP.
3. Brand name of products at S.No. 1 and 2 is given as Umuline Profil 30 100ui/ml and Umuline NPH
100 ui/ ml in the CoPP. The firm has submitted undertaking that they will submit corrected CoPP
with brand names registered in Pakistan within 3-4 months.
7490.
Case is submitted before the Board for a decision.
7491.
678
7492.
Case No. 08. REGISTRATION OF DRUGS OF M/s. EXCEL PHARMAINSPECTION ABROAD ALREADY CONDUCTED
7493. M/s Excel Health Care, Karachi has applied for registration of their following
products. The company have deposited an amount of Rs 100,000/- against each product: 7494.
679
15.
18.19.
16.
21.
22.
17.
20.
23.
7495.
24.
25.
27.
28.
29.
1.
31.
32.
37.
26.
38.
45.
46.
53.
54.
61.
62.
69.
70.
33.
34.
35.
30.
39. 40.
2.
Care Laboratories
(Pvt) Ltd, Karachi
43.
49.
50.
(Pvt) Ltd, Karachi
51.
52.
Excel Health
57.
Care Laboratories
58.
(Pvt) Ltd, Karachi
59.
63. 64.
5.
44.
Excel Health
Care Laboratories
55. 56.
4.
41.
42.
47. 48.
3.
36.
Excel Health
60.
Excel Health
65.
Care Laboratories
66.
(Pvt) Ltd, Karachi
67.
680
68.
7496. The policy of advance parallel inspection was discussed in 237 th Meeting of
Registration Board; however, the policy was revised in 238th Meeting of Registration Board.
Meanwhile, the inspection abroad was conducted which is summarized above. Earlier the case was
placed in 244th Meeting of Registration Board where in it was decided that the case is in complete
and should be processed through ECBD.
7497.
Matter is placed before the Board for a decision.
7498.
7499. Case No. 09. EXEMPTION OF URDU TEXT ON INFLUVAC SUSPENSION FOR
INJECTION (reg. No. 028437) by M/s. Abbott laboratories Pakistan (limited)
7500.
The following product of the firm M/s. Abbott Laboratories (Pakistan) Limited,
Karachi was registered in 2003.
7501.
No.
S. 7502.
No.
Reg. 7503.
Name of drug and

7504.
composition
Manufacturer
7505.
7507.
1. 7508.
1
02843
Name of
7509.
7512.
7506.
Change of Manufacturer Name and
date
And date of Reg.

Solvay
Pharmaceuticals,
Netherlands
7510.
7513. (24.02.2003)
7514.
Abbott Health Care Products,
Netherlands
7515.
(24.08.2011)
7511.
7516.
681
7517.
The firm has requested to grant one time import permission of 5000 packs (Pack size 10s) as
they are first time importing the product. The firm has also informed that they shall print the Urdu text at their
licensed premises at Abbott Laboratories (Pakistan), Opposite Radio Pakistan transmission centre, Hyderabad
Road, Landhi Karachi.
7518.
The case is placed before the Board for a decision.
7519.
7520.
Case No. 10. EXTENSION IN EXEMPTION FOR THE BIOLOGICAL

DRUGS IMPORTED FROM M/S FERRING GERMANY BY M/S ATCO
KARACHI.
7521. Atco Laboratories Limited, Karachi have submitted that they are
importing following Biological drugs from M/s Ferring Pharmaceutical, Germany since 1994
that are in the process of shifting their manufacturing facility and it would not be possible for
them during this period to incorporate all requirements according to their local labeling rules on
the packaging material. As these products are rare/ already in the market and patient needs them,
therefore, M/s Atco Laboratories Limited, Karachi has requested for extension in exemption in
Labeling and Packing Rules for the Biological Imported Drugs for at least twenty months are
more: 7524.
7528.
7532.
7525. Exe
mption
requeste
d
7526.
7529.
Generic Name not in bracket.
ii) Drug registration number to be printed locally.
iii) MRP to be printed locally.
iv) Urdu instruction to be printed locally.
v) Pharmaceutical specification.
7533.
7534. -do-
7537.
7538.
7539. -do-
7542.
7543.
7544. -do-
7546.
682
7547. The Drug Registration Board in its 246 th Meeting has

decided to grant only exemption in urdu version at time of
import and print locally at the licensed manufacturing site.
The firm has approached once again with request to grant
exemption for all the five requirements tabulated above.
7548.
The Board in its 248th Meeting decided to offer personal hearing opportunity to the firm. The
firms representative is called for the personal hearing before the Board.
7549.
7550.
Case No. 11. EXTENSION IN SHELF LIFE of already registered drug

namely Novo Seven 1mg/ml (reg.no. 066157) and Novo Seven 2mg/ ml (reg.
no. 066158) of m/s. Novo Nordisk Pharma, Karachi.
7551. M/s. Novo Nordisk (Private) Limited, Karachi have requested to approve the
extension of shelf life of their following registered drugs from 24 months to 36 months. As the
current stability studies conducted on this product confirms that the product is well stable when
tested at 36 month time interval:7552.
7553.
7554.
7555.
7556.
7557.
7558.
7559.
7563.
7564.
7565.
7566.
7560.
683
7561.
7562.
7567.
7568.
7572.
7573.
7574.
7575.
7569.
7570.
7571.
7576.
7577. The firm has deposited required fee Rs.5000x2=10,000/- and submitted following
supporting documents:7578.
i) Form 5-A
684
7579.
7580.
by
7581.
ii) Copy of registration letter of NovoSeven 1mg and NovoSeven 2mg Injection.
iii) Original CoPP of NovoSeven 1mg Injection and NovoSeven 2mg injection attested
7582.
7583.
7584.
iv) Summary of Product Characteristics

v) Stability Data for 36 Months.
7585.
Submitted for consideration of Drug Registration Board.
Embassy of Pakistan.
7586.
7587.
Case No. 12. EXTENSION IN SHELF LIFE, CHANGE OF MANUFACTURER

NAME OF THE PRINCIPAL AND CHANGE OF EXCIPIENTS OF ALREADY
REGISTERED DRUG NAMELY VAXAPOX, (LIVE ATTENUATED VARICELLA
VACCINE, LYOPHILIZED, REG. NO. 074628) OF M/s. SIND MEDICAL
STORES
7588. M/s. Sind Medical Stores, Karachi has requested to approve the
followings:
1. Shelf life extension for their registered product i.e. VaxaPox, Live Attenuated Varicella
Vaccine, Lyophilized), Reg. no. 074628, from 18 months to 36 months.
7589. The firm has deposited required fee Rs.100,000.00 and
submitted the following supporting documents:i)
ii)
iii)
iv)
v)
vi)
Bank deposit slip for Rs. 100,000/- (One Hundred Thousand only) as a product registration
variance DRAP fee.
Original letter of the manufacturer regarding change of total shelf life of the product.
Notarized (CCPIT) copy of SFDA China approval for the said change in the products shelf
life from 18 months to 36 months.
Stability Data for the extension of VaxaPox total shelf life from 18 months to 36 months.
Copy of the Pak Embassy attested Free Sale Certificate (FSC) for Varicella Vaccine.
Scanned copy of the Brochure for the said product.
7590.
2. Change in the name of manufacturers company name due to the principal company
internal matters from M/s. Changchun BCHT Biotechnology Co. Ltd., China to M/s.
Changchun BCHT Biotechnology Co., China
7591.
7592.
i)
The firm has submitted the following supporting documents for the said change:-
Original letter from the manufacturer regarding change in the name of company.
ii)
Copy of SFDA - China approval for the said change.
iii)
Original authorization letter from the principal company for the local agent.
685
iv)
v)
vi)
Copy of the Pak Embassy attested FSC for the product with the new name of the company.
Pak Embassy attested cGMP Certificate with the new name of the company.
Copy of Bank Deposit slip in account of DRAP fee for the change of company name.
7593.
3. Change of excipients in the formulation of the product i.e. Vaxapox, (Live attenuated
7594.
Varicella vaccine, lyophilized).
7595.
7596. The firm has requested for the approval of the following for the
said product:
7597.
7598. Old
Version and
list of
Excipients of
VaxaPox
(Varicella
Vaccine,
Live)
7599. (From)
7602.
1- 1- The Stabilizer of the harvest virus liquid has

1been changed from:
7603. Phosphat
e
buffer
containing
5% Sucrose
2and
1%
Human
Albumin.
7604.
23- 2- Preparation of the final bulk product has been
changed from:
7605. according
to the virus
titer,
the
formed virus
liquid can be
7600. New
Version and
Changed
Excipients of
VaxaPox
(Varicella
Vaccine,
Live)
7601. (To)
7607.
Phosphate Buffer containing 5% Sucrose,

2.5% Dextran, 2% Mycose, 0.8% Sodium
Glutamate, 0.4% Urea, 0.18% Arginine, 0.1%
Glucose and 1% human Albumin.
7608.
7609. Accordin
g to virus
titer,
the
formed virus
liquid can be
properly
diluted
by
addition of
the harvest
virus liquid
and
mannitol in
1% of the
686
properly
diluted
by
addition
of
0.7%,
Gelatin, 0.8%
Sodium
Glutamate,
0.4% Urea,
0.18%
Arginine,
0.1%
Glucose
final
concentratio
n.
7606.
7610.
7611. And the firm has submitted the following supporting
documents:i)
ii)
iii)
iv)
Original Principal Company letter for the said change.

Copy of SFDA - China approval for the change in excipients of the product.
COA for the Excipients which are included in the said vaccine.
Product insert sheet with mentioning the Composition of the vaccine including excipients of the
said vaccine.
7612.
7613. Firm has also submitted revised Form 5-A with all the relevant
information.
7614. The case has initially discussed in the 241 st DRB meetings held
on 23-12-2013 and had been referred the case to the ECBD for their
recommendation.
7615. Matter is placed before the Board for its consideration.
7616.
7617.
Case No. 13. LOCAL MANUFACTURING OF BIOLOGICAL DRUGS BY M/s.

GETZ PHARMA, KARACHI.
7618.
A. Product Unipeg (Interferon alfa 2a) 180mcg in vials and 180mcg in Prefilled syringes(2products).
7619.
7620.
The firm shall import the interferon concentrate from Beijing Kawin, China and
local formulation and pegylation at their own facility.

687
7621.
7622.
7623. Docu
Docu
ments /
Data
submitt
nt
ed
s/
M/s
Macter,
at
Karachi
7624.
by
a
re
q
ui
re
d
as
p
er
2
4
6t
h
R
B
m
ee
ti
n
g
1.
7625.
Legali
7626. GMP Legalized
by
certificat
embassy
ze
Pakistan
No.CN2
indicate
0130242
Manufacturing
dated
interferon alfa 2a.
of
but
688
not
the
of
03.09.20
ce
13, valid
rti
till
fi
02.09.20
ca
18
te
issued to
of
M/s.
bi
Beijing
ol
Kawin
Technol
gi
ogy
ca
issued
by
dr
SFDA
China
confirmi
as
ng
an
recombi
ev
nant
id
human
en
interfero
ce
n alfa 2b
th
injection
at
s but not
th
for
interfer
on alfa
an
2a.
7627.
uf
ac
tu
re
r
is
689
an
au
th
or
iz
ed
m
an
uf
ac
tu
re
r
of
th
at
pa
rti
cu
la
r
bi
ol
o
gi
ca
l
dr
u
g
in
its
co
u
690
nt
ry
of
or
ig
in
.
7628.
7629.
7630. CoPP
7631.
for
interfero
n alfa 2a
3MIU
finished
drug
issued
by
Beijing
Food
and
Drug
Adminis
tration
China.
2.
7632.
7633. Data
Struct
from
ur
Beijing
al
Kavin is
si
not
provided
il
7634.
691
ar
InProPh
it
arma,
Netherla
of
nds
su
request
bj
of Getz
ec
Pharma,
conduct
bi
ed
ol
structura
gi
similarit
ca
y studies
at
dr
indepen
dent
entity
pr
that
SGS
Laborat
uc
ories,
Woking
(c
ham,
UK.
nc
en
tr
on
is
Intact mass.
Automated N-Terminal sequences.
at
e/
re
ad
y
to
fil
692
l
b
ul
k
fo
r
fu
rt
he
r
pr
oc
es
si
n
g)
w
it
h
re
fe
re
nc
e
bi
ol
o
gi
ca
l
pr
o
d
uc
693
t
(i
n
n
o
va
to
r)
3.
7635.
7636. The
Manu
product
fa
Unipeg
ct
is
ur
already
er
registere
to
d in the
name of
an
the
uf
compan
ac
y and is
tu
importe
re
d in bulk
th
concentr
ate form
fi
from
ni
M/s.
sh
InProPh
ed
arma,
bi
Netherla
ol
nds.
7637.
o
gi
ca
l
pr
694
o
d
uc
t
fo
r
tri
al
st
u
di
es
.
4.
7638.
Bioco
m
pa
ra
7639. Refer
ence
product
used is
Pegasys
180mcg
(19.23K
DA).
7650.
7651.
bi
lit
y
st
u
di
es
in
cl
u
di
n
g
id
en
7640. Appe
arance
clarity
physical
testing.
7652.
7641. Identi
fication
by RP
HPLC.
7642. Poten
cy
by
ELISA.
7643. Poten
cy
by
Biologic
al
695
tit
y
te
sti
n
g
to
pa
re
nt
m
ol
ec
ul
e,
p
ur
it
y
te
Activity.
7644. Impu
rities of
Molecul
ar
Masses
by SDS
page.
7645. Steril
ity
testing.
7646. Endo
toxin by
LAL.
7647. Toxic
ity
testing
AMES2
assay...
Mutagen
ecity,
g,
7648. Syria
n
Hemeste
r Mice.
in
7649.
sti
n
vi
tr
o
bi
ol
o
gi
ca
l
ac
696
ti
vi
ty,
p
ot
en
cy
an
d
to
xi
ci
ty
w
it
h
su
p
p
or
t
of
is
oel
ec
tr
o
fo
cu
si
n
g
da
697
ta,
ge
l
el
ec
tr
o
p
h
or
es
is,
W
es
te
rn
Bl
ot
an
d
ot
he
r
an
al
yt
ic
al
te
ch
ni
q
ue
698
s)
an
d
st
ab
ili
ty
st
u
di
es
of
fi
ni
sh
ed
bi
ol
o
gi
ca
l
pr
o
d
uc
t
5.
7653.
Other
s
7654. Clini
cal
studies
conduct
ed
on
Peg-in
publishe
d
in
Internati
7658.
699
onal
Journal
of
Pharmac
y 2013
3(4):655
-662 ISS
No.2249
-1848
7655. Stabil
ity
studies
on 10%
of
commer
cial
scale
batches
(3batches).
7656. Phar
maco
vigilanc
e data
7657.
7659.
B. Product Enoxa (Enoxaparin 20mg/0.2ml, 40/0.4ml, 60mg/0.6ml, 80mg/0.8ml) in prefilled
syringe form
7660.
Import of concentrate powder from M/s. Hebei Changshan Biochemcial Pharmaceutical
Co., Ltd., China and local formulation at the firms facility.

7661.
7662.
7663.
Do
7664. Docu
7665.
ments /
Data
submitt
ed
by
M/s
700
Macter,
Karach
i
1.
7666.
Le
7667. GMP
7668. Legalized by
certifica
embassy of Pakistan
te
but not indicate the
No.CN2
Manufacturing of
013031
Enoxaparin.
4 dated
15.01.2
013,
valid till
7669. The
also
firm
provided
has
the
company credentials.
14.10.2
018
issued
to M/s.
Hebei
Changs
han
Bioche
mical
Pharma
ceutical,
Shijiazh
uang,
China
issued
by
SFDA
China
for
manufac
turing of
small
701
volume
parental.
7670.
7671.
7672. CoPP
7673.
for
Enoxap
arin
finished
product
issued
by
China.
702
2.
7674.
7675. Data
Str
7676.
from
Hebei
China is
certifica
te
of
analysis
as USP
35
and
in house
specific
ations
for;
3.
7677.
Characterization
Identification
pH
Specific absorbance
Benzyl Alcohol
Sodium
Nitrogen
Heavy metal
LOD
Sulphates
BET
Microbiological Examination
Solvents
Anti factor Xa activity.
Anit factor IIa activity
7678.
7679.
Ma
703
4.
7680.
Bi
7681. Refer
ence
product
used is
Clexane
(Sanofi
Aventis.
......)
7693.
7694.
7682. As
per USP
35
7683. Appe
arance
7684. Clari
ty
7685. pH
7686. Ident
ification
7687. Assa
y
7688. Anti
factor
Xa to
7689. Anti
factor II
a
7690. Steril
ity
704
7691. Endo
toxin
7692.
5.
7695.
Ot
7696.
Stability studies as per ICH
Q1 for 3 batches for 6 months.
7697.
7698.
7699.
7700. Case is placed before the Board for a decision.
7701.
Case No. 14. EXTENSION

IN
CONTRACT
MANUFACTURING
OF
BIOLOGICAL DRUGS BY M/s. SCOTMAN PHARMA, ISLAMABAD FOR M/s.
WERRICK PHARMA, ISLAMABAD
7702. The firm M/s. Werrick Pharam, Islamabad has requested for the
grant of extension of toll manufacturing of below mentioned
products from M/s. Scottman Pharma, Islamabad.
705
7703.
128.
129. Name of the

Drug
130.
Re
7704.
T
132. Cell-Aid
134.
Depot
Injection
03
h
80mcg
e
133. (Interferon
Alfa 2b)
135.
136. Cell-Aid
138.
Depot Injection
03
100mcg
137. (Interferon
Alfa 2b)
139.
140. Cell-Aid
142.
Depot Injection
03
120mcg
141. (Interferon
Alfa 2b)
143.
144. Cell-Aid Alfa
146.
2a 3miu
03
145. (Interferon
Alfa 2a)
147.
148. Cell-Aid Alfa
150.
2b 3miu
03
149. (Interferon
Alfa 2b)
151.
152. Cell-Aid
154.
Depot Injection
03
50mcg
153. (Interferon
alfa 2b)
firm has informed that the last extension for toll manufacturing was valid upto 31.08.2013 after which the
131.
extension has not been granted.

7705.
The case of M/s. Scottman Pharma, Islamabad was under review for the status of section
for biological drugs. The case also remained under investigation by NAB. The Licensing Board in its
239th Meeting has approved the section of bio tech anti virals and bio tech interferon sections of the firm.
Further, the Board in its 246 th Meeting has also devise the policy for the grant of registration of
biological products.
7706.
The matter is placed before the Board for a scientific deliberation on harmonization of
registration requirements, as per decision recorded in 247 th meeting of DRB and on Policy of Contract
Manufacturing of Biologicals.
7707.
706
7708.
7709.
7710.
7711.
Case No. 15. CHANGE IN FORMULATION OF ALREADY REGISTERED

DRUG PREMARIN 0.3MG TABLETS (REG. NO. 039594)
7712.
7713.
7714.
7715.
7716.
7717.
7718.
7719.
7720.
7722.
7723.
7724.
7725.
7721.
7726.
7727.
7728.
7729.
7730.
707
7731. And the firm has submitted the following supporting

documents:7732.
i.
ii.
iii.
iv.
v.
Fee of Rs:100,000
Form 5-A
Registration Letter/Renewal Status of Premarin 0.3mg Tablets
CoPP legalized by Embassy of Pakistan
NOC for CRF
7733.
7734.
please.
The matter is placed before the Board for a decision
7735.
7736.
7737.
7738.
7739. Case No. 16.

MMR VACCINE CASE OF M/S.
AMSONS VACCINE AND PHARMA,
ISLAMABAD
7740.
7741. The vaccine name Measles, Mumps, Rubella vaccine live, attenuated (freeze
dried) was registered in the name of M/s. Amsons Vaccine and Pharma (Reg. No. 013272). As
per copy of transfer of registration, the product is registered in the form of Naked vials from
Serum Institute of India and local repacking at M/s. Amson Vaccine and Pharma, Islamabad.
The company has now informed that the manufacturer abroad has difficulty in exporting naked
vials. The firm has requested to grant permission to import labeled vials instead of naked vials.
7742. Request of the firm is placed before the Board for a decision.
7743.
7744.
Case No. 17.
VETERINARY BIOLOGICAL DRUGS
7745.
7746.
The following applications of veterinary biological drugs are placed before the Board.
7747.
7748.
7749.
7750.
7751.
7752.
708
7753.
7754.
7755.
7758.
7761.
7762.
7764.
7763.
7756.
7759.
7757.
7760.
709
7765.
7766.
7767.
7770.
7768.
7771.
7774.
7775.
7777.
7778.
7790.
7791.
7776.
7772.
7769.
7773.
7779.
7780.
7783.
7787.
7788.
7789.
7781.
7784.
710
7785.
7782.
7786.
7792.
7793.
7796.
7799.
7800.
7802.
7801.
7794.
7797.
711
7803.
7798.
7795.
7804.
7805.
7807.
7809.
7810.
7812.
7811.
7808.
7806.
712
7813.
7814.
7815.
7817.
7819.
7820.
7822.
7821.
7818.
7816.
713
7823.
7824.
7825.
Currently the division has some products which are contract manufactured in previously
known as Eastern Europe and now are part of EU/EMA, like Hungry, Slovakia, and Serbia and release site
and mother institute is in France (Western Europe).
7826.
Matter is placed before the Board for a decision
7827.
714
7828.
7829. Item No.V:
Division.
7830.
A,
7831.
Quality Assurance & Lab Testing
Deferred Cases
Case No.1 Manufacture & Sale of Substandard Drugs Galtran 50mg Tablet, Batch
No. 483 by M/s Gaba Pharmaceutical Laboratories Karachi.
7832. Brief of the Case.
7833.
The sample of Galtran (Diclofenac Na) 50mg Tablets Reg. No. 061316 Batch No. 483
Mfg. Date. 05-13 Exp Date. 05-15Manufactured by M/s Gaba Pharmaceutical Laboratories, Karachi drawn
by FID Karachi-II from manufacturing premises on 08-01-2014, was declared Substandard vide CDLs test
report No.KQ.33/2014 dated 06th March 2014 by Federal Government Analyst. On explanation letter
issued by the FID, the firm challenged the CDL report and requested for Appellate Testing under Section
22(5) of Drugs Act, 1976. The Appellate Laboratory also declared the sample as Substandard vide their test
report 04-MNHRS/2014 dated 03rd July 2014. The results of the CDL and NIH on the basis of which the
drug sample has been declared substandard are reproduced as under:7834. FGA,
CDLs
Report
7836. SubStandard
with regard
to:7837.
7838. Disinteg
ration
Time:(The
Tablets
Cracked in
0.1M HCl
and
the
contents
escaped
into
the
medium)
7839.
7840. Does
not comply
7841.
7842. Remark
7835. Appellat
e Lab
Testing
7846. SubStandard
with regard
to:7847. Disintegr
ation Time:7848.
7849. Determin
ed:- All the
six tablets
shows sign
of cracks
and
disintegratio
n in the first
two hours in
0.1M HCl
7850.
7851. Limit:Tablets
should not
show any
715
s:The
sample is of
Substand
ard
quality
under the
Drugs Act
1976.
7843.
7844. Test
Report No.
KQ33/2014
7845. Dated
06-03-2014
sign of
cracks or
disintegratio
n in the first
two hours in
0.1M HCl
7852.
7853. Does not
comply with
BP 2011.
7854.
7855. Conclusi
on:The
sample is of
Substanda
rd quality
on the basis
of the test
performed.
7856.
7857. Test
Report
No.04MNHSR/20
14
7858. dated 0307-2014.
7859.
2.
The FID has concluded that the Company M/s Gaba Pharmaceutical Labs, Karachi is guilty
of manufacturing substandard drug. and has violated Section 23(1)(a)(v) of the Drugs Act
1976 The FID has requested permission for prosecution in the Drug Court Sindh Karachi and
for cancellation of registration of drug The FID has sent the names of following persons
involved in the manufacturing of substandard drug:
7860.
7861.
7862.
7863.
7864.
3.
i
ii.
iii.
iv.
.
M/s Gaba Pharmaceutical Labs, Karachi

Mr. M. Amin,
(Proprietor)
Mr. Mehrab Ali
(Quality Control Manager),
Mrs. Zakia Rana (Production In charge),
As per procedure a show cause notices were issued to the firm and its other accused persons,
offering opportunity of personal hearing before the Drug Registration Board.
4.
The case was placed before Drug Registration Board in its 248 th meeting held on 19 th March
2015. The accused persons were also called for personal hearing in the said meeting of the Board
but the owner of the firm submitted that due to illness it is not possible for them to come for
716
personal hearing. The Board decided to defer the case till next meeting. They have been called for
personal hearing again accordingly.
7865.
7866.
The case is submitted for the consideration of the Board, please.
7867.
7868.
Case No.02
Manufacture & Sale of Sub-Standard Drug- Regogent Eye/Ear
Drops Batch .No. E-058 Mfd. by M/s Amros Pharmaceutical Karachi. (F. No. 0339/2014-QC)
7869. Background of the case:
7870.
The Assistant Drugs Controller (ADC), Karachi, Ms Ume Laila vide her letter date 15-
07-2014 intimated that she took the sample of the dug under reference from the export consignment for
Nigeria on 20-01-2014. It was further submitted that the drug sample has been declared as of substandard
quality by FGA, Central Drug Laboratory (CDL), Karachi vide its test report No.EXP.19/2014, dated 14 th
July 2014. Salient features of the CDL test report are reproduced as under
7871. Assay for Gentamycin:
7872.
7873.
7874.
7875.
Determined amount %w/v:

Calculated amount %w/v:
Percentage:
Limits:
0.2535%
0.3%
84.5%
90.0% to 135.0% Does not comply.
7876.
7877. Remarks:The sample is of Substandard quality under

the Drugs Act, 1976.
7878.
7879. 2.
As per examination of documents submitted, it was
evident that the drug sample under reference was drawn by the
ADC on 20-01-2014. However the CDL test report reflected that the
sample was received in the Lab on 12-06-2014 meaning thereby the
sample was sent to the Lab almost after four months and 21 days
after its seizure for test/analysis. As per record of this office, it was
also apprised that boards portion of sample has not been received
in the QC Section.
7880. 3.
The ADC concerned was asked for explaining the
reasons for not sending the sample to the CDL Karachi and
717
disposing off the Boards portion with in 07 days vide letter dated
16-09-2014. Both these said actions of the ADC weakened the said
case of substandard drug under reference as mandatory provision
laid down under Section 19(3) of the Drugs Act 1976 was not
complied with.
7881. 04.
In response, the ADC informed that the sample was
delivered to the CDL on 20-01-2014 and acknowledgment receipt

of CDL was furnished in this regard. The Director CDL also
confirmed vide reply dated 23-10-2014 that the sample was sent to
the Lab by ADC Karachi with Form-4 on 20-01-2014. However the
stance of ADC regarding sending Boards portion was not correct as
neither the Boards portions of the samples nor Memorandum
bearing No.UL-01-03/2014-ADC(K) Export dated 20-01-2014 was
not received in the Directorate of QA since January 2014 to 31-102014. As per communication made by the ADC, it is very clear that
the mandatory provision of Section 19(3) of the Drugs Act 1976,
and rules framed there under was not followed. So the ADC was
asked again as why the Boards portion was not forwarded as per
above stated mandatory provision of the law
7882. 05.
The ADC in response to this office letter dated 17-10-
2014 sent retaining sample of the drug under reference and stated
that beside all misunderstanding and minor error of lower staff, I am
again sending the retaining sample of aforesaid batch which was
available in her custody. The view point of the ADC Karachi
regarding sending Boards portion is not correct as no sample as per
memorandum bearing No. UL 01-03/2014-ADC (K)-Export date
20-01-2014 has been received in Directorate of QA/LT Islamabad.
The retaining sample sent by the ADC afterwards and received by
QC Section on 31-10-2014 is without memorandum and can not be
entertained as the same has not been forwarded with in mandatory
07 days time period as prescribed under Section 19(3)(ii) of Drugs
Act 1976.
718
7883.
7884. 06.
The Director CDL was asked to comment on the delayed
analysis of the sample of the drug under reference sent/delivered to

the Lab on 20-01-2014 as same should have been analysed/reported
with in 60 days of the receipt of sample as required under Section
22(2) of Drugs Act 1976. No extension in the testing period was
sought from the competent authority as per record of Directorate of
QA/LT. The test report of the samples was issued on 14-07-2014 i.e.
05 months and 25 days after the receipt of sample by the Lab. It has
also been stated that samples from export consignment are liable to
be charged for testing fee by CDL for test analysis. It was also
submitted that the date of receipt of testing fee is considered as the
date of receipt of sample as per policy framed after repeated
observations by audit and public accounts committee of National
Assembly on outstanding testing fee. In the instant case the relevant
voucher of testing fee for the sample was submitted to CDL on 1206-201, therefore the same was mentioned as the date of receipt of
sample. It has been further stated that CDL tested and reported the
drugs sample under reference with in only one weak after receiving
the sample with complete legal formalities.
7885. 07.
The stance of the Director CDL Karachi is not covered
under the law/rules and any policy followed by the Lab is not in the
record of Directorate of QA/LT uptill now and approved by DRAP.
As per Section 22(2) of the Drugs Act 1976, it is mandatory for
Government Analyst to submit the test report of the sample of any
drug sent to him for test/analysis with in 60 days. The Director CDL
Karachi has not adhered to the above stated mandatory provision of
Section 22(2) of Drugs Act 1976.
7886. 08.
In the instant case the Board portion has not been
received as required under Section 19(3) (ii) of the Drugs Act 1976
and the CDL test report has been issued after the laps of mandatory
time period. In view of above, it was therefore, proposed to place
the case before the Registration Board for consideration, direction
719
and decision as the firm has challenged the CDL test report under
Section 22(4) of the Drugs Act 1976. The Board may also inquire
further from Director CDL Karachi and ADC Karachi on the issue.
7887. 09.
The worthy Chairman Registration Board directed to
bring the case before the Board for discussion.

7888. 10.
The case was placed before Drug Registration Board in
th
its 248 meeting held on 19th March 2015 but due to paucity of time
the Board deferred the case till next meeting of the Registration
Board. The case is again submitted for consideration and further
directions of the Board in the matter.
7889.
7890. Case No.03: Manufacture & Sale of Substandard Drugs
Benzirin-C Mouth Wash, Batch No. 70 by M/s Adamjee
Pharmaceuticals (Pvt) Ltd., Karachi (F.No. 03-04/2014-QC)
7891. Background of the case:
7892.
The Sample of Benzirin-C Mouth Wash Batch No 70, manufactured by M/s Adamjee
Pharmaceutical (Pvt) Ltd Karachi was taken by FID-III, Karachi, Mr. Abdul Rasool Sheikh on 23-122013 from manufacturers premises. It was declared substandard by Federal Government Analyst (FGA),
CDL Karachi vide Test report No. 1013/2013, dated 28-01-2014. On explanation letter issued by the FID,
the firm challenged the CDL report and requested for Appellate Testing under Section 22(5) of Drugs Act,
1976. The Appellate Laboratory also declared the sample as Substandard vide their test report 02MNHRS/2014 dated 24-04-2014. The results of the CDL and NIH on the basis of which the drug sample
has been declared substandard are reproduced as under
7893.
7894. FGA,
CDLs
Report
7897. SubStandar
d
with
regard
to:pH
7898. Determined 4.76
7895. Appellate
Lab Testing
7896.
7905. SubStandard with

regard to:7906.
7907. Assay for
Cetylpyridinium
Choloride
720
7899. Limits
5.0 to 7.0
Does not
comply
7900.
7901. ii.
Assay
for
Benzyda
mine
HCL
7902. Deter
mined
amount
84.666%
7903. Limit:
- 90.0%
to 110%
7904. Does
not
comply
159.94%
7908. Limit:-90%
to 110%
7909. Does not
comply with
manufacturers
specifications.
7910.
7911.
7912.
2.
The FID has concluded that the manufacturer is guilty of manufacturing substandard
drug. The FID has sent the names of following responsible persons involved in the manufacturing of
substandard drugs and has requested for prosecution of the following persons of the firm in Drug Court
along with cancellation of the registration of the product under reference.
7914.
7915.
7916.
7917.
7913.
ii.
Farooq Hamirani,
iii. Shahid Ahmed Khan
iv. Asim Kamal Ansari
7918. 2.
i.M/s Adamjee Pharmaceutical Pvt Ltd Karachi

Managing Director,
Production Manager,
QA Manger,
As per responsibility fixed by the FID, show cause
notice dated 11-06-2014 were issued to the firm and the above
named accused persons of the firm. They were also called for
personal hearing accordingly. The case was considered by the Drug
Registration Board in its 244th meeting held on 23-07-2014.
7919. 3.
7920.
Decision of Registration Board:-
The Board in view of personal hearing of Mr. Asim Kamal Ansari QC Incharge of the
firmand available record/facts of the case decided as under:-
721
7921.
To conduct Product Specific Inspection (PSI) and evaluation of firms Quality
Assurance System by the following panel.
7922.
a.
Director QA/LT,
7923. b. Area FID
7924. c.
Director DTL Karachi
7925.
The report of the panel shall be presented before the Board in its next meeting.
7926. 4.
The report of the panel inspection conducted on 23-122014 has been received and the conclusion of the same is
reproduced as under:-
7927.
The Panel, after reviewing all the necessary documents relating to the post
investigations carried out to find the root-cause of the failure, is of the opinion that the firm is
competent enough to treat and investigate any market complaint and may take necessary steps
to mange the recalls. In this particular case sufficient investigation were also made to
ascertain the cause of the failures at both the Government Labs Rests of the GMP conditions
and QA System was found complaint & good
7928.
7929. Conclusion of the report of the panel for PSI was submitted for
information and appraisal of the Registration Board in its 248 th
meeting held on 19-03-2015 but due to paucity of time the Board
deferred the case till next meeting of the Registration Board. The
case is again submitted for information and appraisal of the Board,
please.
7930.
7931.
B.
7932.
New Cases
Case No.04: Manufacture & Sale of Misbranded

Drug - L.S Minerals
Granules/Powder (For Vet Only) Batch No. V061F45 By M/S Nawan Laboratories
(Pvt) Ltd Animal Health Division, Karachi (F. No. 3-21/2015-QC).
7933.
The sample of L.S Minerals Granules/Powder (For Vet
Only) Batch No. V061F45, Manufactured by M/S Nawan

Laboratories (Pvt) Ltd Animal Health Division, Karachi. drawn by
FID Karachi from manufacturers premises on 11-12-2014, has
been declared Misbranded by the Federal Government Analyst,
CDL, Karachi vide test report No.R.KQ.528/2014 dated 12 th
722
February 2015 . The result of the CDL report is reproduced as

under:7934.
Description:-
Off white to brown coloured granules.
Identification:-
Calcium, Phosphorus, Copper and Iodine identified.
7935.
7936.
7937.
7938. Remarks:-
The sample is a registered product (Registration
Number: 021306) in Pakistan as evidenced by Ministry of health

registration letter, dated 11/5/1998, however the registration number
is not mentioned on the label as required under rule 3(f) of the
Drugs (Labeling & Packaging) Rules 1986. Hence, the sample is
declared Misbranded under Section 3(s)(i) of the Drugs Act
1976.
7939.
7940. 2.
In response to explanation letter issued by the FID, the
firm vide their reply has accepted their mistake and has stated that
some of the stickers escaped impression during stamping of
registration number. It has also been stated that they have rectified
the short coming. The firm did not challenge the CDL test report as
evident from the reply.
7941. 3.
The FID has concluded that the company M/s Nawan
Laboratories (Pvt.) Ltd, Karachi. is guilty of manufacturing

Misbranded drug and has contravened Section 23(1) (a)(iii) of
Drugs Act 1976. The FID has sent the names of the following
responsible persons have been furnished along with the case
documents.
i.
7942.
M/s Nawan Laboratories (Pvt.) Ltd, Karachi.

ii.
Mr. Ehsan Awan ,
(MD/Director),
7943.
iii.
M.Akram Rana,
7944.
iv.
Miss Faryal Sultan
7945.
v.
Mr. Muhammad Rashid
Plant Manager
(Production Incharge
(QC Manager)
7946.
723
7947. 4.
As per procedure show cause notices have been issued to
the firm and above named accused persons, offering opportunity of

personal hearing before the Drug Registration Board. They have
been also called for personal hearing.
7948.
The case is submitted for the consideration of the Board.
7949.
7950.
7951.
7952.
7953.
7954.
7955.
7956.
7957.
7958.
7959.
7960.
Case No.05: Manufacture and Sale of Adulterated &Substandard Phenviler

Injection, Batch No. J-1913, By M/S Ahsons Drug Company, Tando Adam-Sindh F.
No. 03- 27/2015-QC.
7961.
The Federal Government Analyst, CDL Karachi vide
which sample of subject cited drug has been declared Substandard

vide test report No. R.KQ.81/2015 dated 06th March 2015. The
result of CDL on the basis of which sample under reference has
been declared sub-standard are reproduced as under:7962.
Description:Colourless Solution in ambered glass ampoule containing

visible black particles. Does not comply.
7963.
7964. Remarks:- The sample is Adulterated and Sub-Standard
under the Drug Act 1976
724
i.
.
7965. The FID served an explanation letter to the firm. The company in
response vides their reply dated 30-03-2015 did not challenge the
report and has submitted as under:
i.
That during optical checking of the said batch of the Drug a few rejected ampoules
were unfortunately mixed up with the released ones and ultimately packed
unintentionally.
7966.
ii.
That investigation was conducted to ascertain the source of black particles and no
deviation was found during any stage of production and that the firm is taking extra
care during washing of ampoules.
7967.
iii.
That since registration of the product i.e. 1999, no such type of complaint was
launched from market/customers or any regulatory authority.
7968.
iv.
That the whole batch has been voluntarily withheld and recalled back and
quarantined in factory premises till further instructions of the authorities.
7969.
v.
That the firm has requested to withdraw this case in the light of aforesaid submission
etc.
7970.
7971.
The FID after pursuing the firms reply has furnished
names of following Directors and Technical Staff of the firm for

violation of Section 23(1)(a)(iv) & 23(1)(a)(v) of Drugs Act, 1976
and has recommended:7972.
a.
Cancellation of registration of drug under reference.
b.Permission for prosecution against the above name persons of the company.
7973.
7974. i. M/s Ahsons Drug Company, T/1, SITE, Tando Adam, Sindh.
7975. ii. Abdul Wahan Ansari, Managing Director of the firm.
Syed Anwar Ali Bukhari, Quality Control Manager.
Tanvir Ahmed Memon, Production Incharge.
7976.
7977. .
the firm and accused persons of the firm offering opportunity of

personal hearing before the Drug Registration Board. They have
been also called for personal hearing.
7978. The case is submitted for the consideration of the Board.
7979.
725
Case No.06: Manufacture & Sale Of Sub-Standard Drug- Jfalbazin Oral

Suspension (For Vet. Only) Batch No.Jfl.1305, Reg No. 041265 By M/S Jfrin
Pharmaceutical Laboratories, Hub Balochistan (F. No.3-05/2015-(QC)
7980.
7981.
7982.
The Sample of Jfalbazin Oral Solution (For Vet. Only) Reg No. 041265, Batch
No.Jfl.1305 By M/S Jfrin Pharmaceutical Laboratories, Plot No. 17& 20 Hub Balochistan was taken by
FID Quetta at Karachi on 30-12-2014 from manufacturers premises. It was declared substandard by
Federal Government Analyst vide .KQ.610/2014 dated 13 th January 2015. The Appellate Laboratory also
declared the sample as Substandard vide their test report 02-MNHRS/2014 dated 30-03-2015. The results
of the CDL and NIH on the basis of which the drug sample has been declared substandard & Misbranded
respectively which are reproduced as under:7983.
7984. FGA,
CDLs
Report
7986. SubStandard
with regards
to
7987.
7988. Assay for
Albendazole:
7989. Determine
d
amount/100ml
: 1.98275g
7990. Stated
amount/100ml
: 2.5g
7991. Percentage:
79.31%
7992. Limits:
90.0%to
110.0%
7993.
7994. Does not
comply.
7995.
7996.
7997. Remarks:The sample is
7985. Appellat
e Lab
Testing
8001. Remarks
:8002. (Variation
in the colour
of the label
on
immediate
and
outer
packing in
the
same
Batch
No.JFL1305
has
been
observed).
Reference of
Pharmacopo
eia i.e. BP,
USP,
or
manufacture
rs
specification
is
neither
mentioned
on
the
immediate
pack nor on
the
outer
726
of
Substandar
d
quality
under
the
Drugs
Act
1976.
7998.
7999. Test Report
No.
KQ610/2015
8000. Dated 13th
January 2015
packing
which
is
violation of
packing and
labeling
rules
of
Drugs Act
1976
8003.
8004. Conclusi
on:The
sample
is
Misbranded
8005.
8006. Test
Report
No.02MNHSR/20
15
8007. dated 3003-2015.
8008.
8009. 2.
In response to the explanation letter issued by the FID
has concluded that the firm has violated Section 23(1)(a)(v) of
Drugs Act 1976. FID has recommended as follows.
8010.
a.
Based on report of FGA, CDL the FID had directed the firm to hold the sale &
manufacturing of under reference drug till finalization of the report and upon subsequent
instruction from the Director Quality Assurance the matter would be taken up as per provision of
DRAP Act, 2012 and Drugs Act, 1976. The FID has informed that as per reply of the firm the
instruction given to firm seemed complied and the defective batch was up held for further
investigations.
8011.
b.
The FID has recommended that the registration of the Drug under reference may be
cancelled after due deliberations in the up-coming meeting of Registration Board and further
recommended that permission for prosecution against all involved in the manufacturing of said
drug (Jfalbazin Oral Solution, Reg No. 041265) may be granted.
8012.
8013. 3.
However the FID has furnished the names of the
following persons of the firm responsible for the offence.
8014.
8015.
8016.
8017.
8018.
i.
ii.
iii.
iv.
M/S Jfrin Pharmaceutical Laboratories, Hub Baluchistan.

Ms Rukhsana Parveen,,
Director,
Mr. Javed Ahmed,
Production Incharge,
Mr.S.Manzer Ahmed
Q.C Incharge,
8019.
727
8020. 4.
An explanation letter was issued by the FID to the firm.
The firm had requested Appellate Testing under Section 22(5) of

Drugs Act, 1976 from Appellate Lab, NIH, Islamabad. The sample
were sent to Appellate Lab NIH Islamabad which declared the
sample as of Misbranded
8021. 5.
the firm and accused persons of the firm offering opportunity of

personal hearing before the Registration Board. They have been
also called for personal hearing.
8023.
8024.
Case No.07: Manufacture and Sale of Substandard Synocip (Ciprofloxacin)

250mg Tablets Batch No. T-4019 By M/s Synchro Pharmaceuticals Lahore. No.F.359/2014-(QC)
8025.
The sample of Synocip (Ciprofloxacin) 250mg Tablet
Batch No. T-4019 manufactured by M/s Synchro Pharmaceutical

Lahore, drawn by FID Lahore-I on 17-10-2014 from manufacturer
premises were declared substandard by Federal Government
Analyst vide Test report No. LHR.258/2014 dated 16-12-2014. A
letter was sent to FID on 30-12-2014 and 23-01-2015 by DRAP
Islamabad. An explanation letter was issued by the FID to the firm.
The firm had requested Appellate Testing under Section 22(5) of
Drugs Act, 1976 from Appellate Lab, NIH, Islamabad. The
Appellate Laboratory also declared the sample as of Sub-standard
quality vide its test report No. 01-MNHSR/2015 dated 19 March
2015. The results of the CDL and NIH on the basis of which the
drug sample has been declared substandard & Misbranded are
reproduced as under:8026. Sub-Standard with regard to Dissolution Test:
8027.
8028. (CDL Result)
Stage-1
728
8029.
8030.
8031.
8032.
8033.
8034.
8035.
8036.
8037.
8038.
8039.
8040.
8041.
8042.
8043.
8044.
Limits for (Stage-1):- Each unit is not less than
Q+5% i.e. 75+5=80%
8045. Stage-2
8046.
8047.
8048.
8049.
8050.
8051.
8052.
8053.
8054.
8055.
8056.
8057.
8058.
8059.
8060.
8061. Average of 12 units = 769.849/12=64.154%

8062.
8063.
Limits for (Stage-2):- Average of 12 units (S1+S2) is equal to or greater than Q

(75%) and no unit is less than Q-15% (75-15=60%)
8064. Does not comply with USP 37.
8065.
Remarks:- The sample is of Sub-Standard
quality under the Drug Act 1976.
8066.
729
8067. Sub-Standard with regard to Dissolution Test.

8068. (Appellate Testing Result):
8069. Dissolution Test
8070. Determined amount:
8071.
53.16%
Limits: Not less than 80% of the stated amount Does not comply with
USP-32.
8072. Remarks:The sample is of Substandard quality on the
basis of tests performed.
8074.
8075.
Case No.08: Manufacture & Sale Of Sub-Standard And Adulterated DrugJfenroxil (Enrofloxacin) Oral Solution (For Vet. Only) Batch No.Jfl.4511 By M/S
Jfrin Pharmaceutical Laboratories, Hub Balochistan
8076.
The Sample of Jfenroxil (Enrofloxacin) Oral Solution (For Vet. Only) Batch No.Jfl.4511
By M/S Jfrin Pharmaceutical Laboratories, Plot No. 17& 20 Hub Balochistan was taken by FID Quetta at
Karachi on 30-12-2014 from manufacturers premises. It was declared substandard and Adulterated by
Federal Government Analyst vide .KQ.611/2014 dated 05 th January 2015. which is reproduced as under,
The company had not challenged the report of CDL Karachi
8077. FGA, CDLs Report
8078.
8079. Adulterated
&
Substandard with regards
to Description:8080. Finding of Lab:8081. Faint Yellow solution in
clear glass vial containing
visible black particles.
8082. Does not comply
8083. Remarks:8084. The
sample
is
Adulterated
8086.
730
&Substandard under the

Drugs Act 1976.
8085. Test
report
No.
R.K.Q.611/2014 dated 2201-2015
8087.
8088. 2.
In response to the explanation letter issued by the FID
Baluchistan has concluded that
8089. the firm has violated Section 23(1)(a)(iv) and 23(1)(a)(v) of
Drugs Act 1976. FID has recommended as follows
8090.
a.
Based on partial report of FGA, CDL the firms registration may be cancelled in
up coming meeting of RB.
8091. 3.
The FID Baluchistan at Karachi has furnished the names
of the following persons of the firm responsible for the offence.
8093.
8094.
8095.
8096.
ii.
iii.
iv.
8092.
i.
Baluchistan.
Ms Rukhsana Parveen,,
Mr. Javed Ahmed,
Mr.S.Manzer Ahmed
8097. 4.
M/S Jfrin Pharmaceutical Laboratories, Hub

Director,
Production Incharge,
Q.C Incharge,
A show cause notice was issued to the firm on 12-03-
2015 and other accused, offering opportunity of personal hearing

before the Registration Board. The representative of the firm could
not appeared before the Board. The Registration Board in its 248 th
meeting decided the case as under:8098. Due to paucity of time the Board deferred the case till next meeting of the
Registration Board accordingly the firm has been called again for personal hearing.
8099.
8100. 5.
The firm now again has been called for personal hearing
before 249th meeting for Registration Board and the representative

and responsible persons of the firm have again been called for
personal hearing in the light of decision taken before 248 th meeting
of the Board..
731
8102.
8103. Case No. 09 (CARRY FORWARD):
Spurious
of
Registration of Tyno SF Cough Syrup of M/s Reko Pharmacal,
Lahore and Dextromethorphan Cough Syrup of M/s Ethical
Lab.
8104. Report of PQCB:
8105.
The Secretary, Provincial Quality Control Board, (PQCB) Punjab had reported that the
PQCB Board, in its meetings held on 29-12-2012 and 11-01-2013 considered the case of substandard
Dextromethorphan Active Pharmaceutical Ingredients, Batch No. DMR-02-12-029 and DMR-02-12-030
Manufactured by M/s Konduskar Laboratories (Pvt) Ltd., MIDC-India, was being used for manufacturing
of Tyno SF Cough Syrup by M/s Reko Pharmacal, Lahore and Dextromethorphan Cough Syrup by M/s
Ethical Labs Lahore respectively. The samples were drawn by Drug Inspector, AllamaIqbalTown, Lahore
from manufacturers premises. The PQCB Board observed that the raw material, in question, was used for
manufacturing of Tyno SF Syrup and Dextromethorphan Cough Syrup, which resulted in death of number
of patient, which is criminal negligence and gross lap in GMP compliance by the manufacturer. The
PQCB decided to recommend to the Federal Government for cancellation of Drug Manufacturing License
of the firms and cancellation of registration of the Drugs. But, detail record/documents relating to the case
has been provided by PQCB Punjab. On receipts of news reports regarding death of a number of persons
at Lahore, who allegedly consumed Tyno SF Cough Syrup of M/s Reko Pharmaceuticals Lahore, the team
of Provincial Health Department sealed the firms premises on 25-11-2012. The Provincial Health
Department de-sealed the factory on 27-11-2012 on administrative grounds.
8106.
Action Taken by DRAP:
8107. As per record/ information available with DRAP, the Board was apprised background of the
case is as under.
8108.
1.
The drugs sales outlets in Lahore were randomly checked by Federal
Inspector of Drugs for availability of the said drug but no stocks were found.
2. A team of Federal Inspector of Drugs and Assistant Drug Controllers inspected the
firm on the same day i.e 27-11-2012 when the company was de-sealed by the
Provincial Inspector. The FID & ADC checked Production and Quality Control
record of the suspected batches of Tyno SF Cough Syrup was checked. Samples of
the four suspected batches of the Syrup and active raw materials used in their
manufacturing were drawn for test/ analysis by the Federal Government Analyst.
The available stocks of Tyno SF Cough Syrup were ordered not to dispose off by
the FID while the active raw material was sealed by the Provincial Drug Inspector.
8109.
732
3. The Federal Government Analyst subsequently declared four suspected batches of

Tyno SF Cough Syrup and the samples of active raw materials Dextromethorphan
(Batch No. DMR-02-12-029) used in their manufacturing as of standard quality
manufacturing. The provincial health authorities later furnished a sub-standard test
repots of DTL Punjab in respect of the same batch Dextromethorphan raw
material, imported from Konduskar Laboratories by M/s Reko,
8110.
4. In December, 2012 another incidence was reported regarding deaths in Gujranwala

due to unknown poisoning, the Punjab health authorities reported that
Dextromethorphan Cough Syrup and Cocil Syrup of M/s Ethical Lab as suspected
drugs. During further investigation it was found that the source of
Dextromethorphan raw material, i.e. M/s Kundoskar India, utilized in these
products was the same as that of Tyno SF Cough Syrup of M/s Reko.
8111.
5. A joint inspection (with the provincial health authorities) of M/s Ethical Labs
Lahore, whose syrup viz Dextromethorphan Cough Syrup and Cocil cough Syrup
(containing Dextromethorphan) were suspected to be involved, was also carried out
on 28-12-2012 and the production and quality control record was thoroughly
cheeked by the inspection team. The entire stocks of suspected drugs present in the
premises were order not to dispose off and 19 different samples of finished drugs
and raw materials were taken for test/ analysis by the provincial inspectors. The
Federal Inspector of Drugs also drew samples of suspected drugs from the firms
premises. The reports of investigation of cause of death are awaited. The Syrup
Section and suspected raw materials of the firm were sealed by the provincial drug
inspectors.
8112.
6. There have been a number of news reports that all the victims were drug addicts
and there is possibility that they have taken some other drugs or narcotics along
with the Cough Syrup in excessive quantities. The Forensic Toxicology Analysis
Report issued by Home Department, Government of Punjab, also reported Opiates,
Cannabinoids, Ethanol, and other sedative/ psychotropic substances in the samples
drawn from 11 victims, suggesting concomitant ingestion of narcotics and other
related substances by them.
8113.
7. The test reports of the samples of finished products and raw materials used in these
cough syrups, sent by Punjab Government to UK for testing, revealed that the two
batches of Dextromethrophan (DMR 02-12-029 & DMR 02/12-030) raw material
imported from M/s Konduskar, India contains heavy contents of Levomethorphan
(up to 22%), which is the semi finished form of Dextromethorphan.
8114.
8. While the role of Levomethorphan and other narcotics / psychotropic drugs

detected in the victims samples is being investigated, both the Provincial
Government and Drug Regulatory Authority of Pakistan has taken necessary
actions to confiscate the imported raw material and finished products from the
market.
8115.
733
8116. The Central Licensing Board took up the matter in its 231st Meeting held on 3001-2013, and after hearing representatives of M/s Reko Pharmacal and Ethical Labs took following
decisions.
i.
8117.
Import of any raw material / drug form M/s Konduskar India is banned forthwith.
ii.
WHO Pakistan may be approached with the request to take up the matter with the Indian
authorities through WHO India.
Suspension of License of Oral Liquid / Syrup Section of M/s Reko Pharmacal for one year or
till completion of investigation and decision by the competent forum, whichever is earlier.
iii.
8118.
iv.
Suspension of License of Oral Liquid / Syrup Section of M/s Ethical Labs for one year or till
completion of investigation and decision by the competent forum, whichever is earlier.
8119.
v.
Recommendations to the Drug Registration Board for Cancellation of Registration of Tyno

SF Cough Syrup of M/s Reko Pharmacal and Dextromethorphan Cough Syrup and Cocil
Syrup of M/s Ethical Labs.
8120.
vi.
Detail panel GMP inspection of the M/s Reko Pharmacal and M/s Ethical Labs
8121.
8122.
The Licensing Board further decided to take up the matter again after completion of
investigation by the relevant quarters.

8123.
The Central Licensing Board after review of the
available details of the case noted that the matter of excessive

consumption of the Cough Syrups along with narcotics and other
related substances by the victims requires to be properly
investigated in order to find actual cause of deaths and subsequent
fixation of responsibility.
8124.
8125. Decision:i.
The CLB took the following decisions.
While endorsing the ban on import from M/s Konduskar India, the Board recommended for
involving trade bodies and diplomatic channels for taking up the matter with the Indian
authorities.
8126.
ii.
Ministry of Commerce may be approached with the recommendation that a cautious approach
made may be adopted for granting Most Favored Nation (MFN) status to the India in view of
the substandard imports.
8127.
734
iii.
A committee with following composition is constituted to thoroughly investigate the matter

and submit its finding and recommendations to the Board on priority basis.
a. Representative from DRAP
b. Representative from the Government of Punjab
c. Two Experts in Pharmaceutical Sciences
d. Any other co-optive member the committee may require
8128.
iv.
v.
Suspension of registration of Tyno SF Cough Syrup of M/s Reko Pharmacal till completion
of investigation and decision by the competent forum.
Suspension of registration of Dextromethorphan Cough Syrup and Cocil Syrup of M/s Ethical
Labs till completion of investigation and decision by the competent forum.
8129.
8130. Consideration of the Case by Registration Board:
8131.
The Drug Registration Board in its 237th meeting held on 26-02-2013 considered in the
light of recommendation of the Secretary, Provincial Quality Control Board (PQCB), Punjab and
Central Licensing Board. The Registration Board in its 237thmeeting taken the following decisions.
8132.
While endorsing the ban on import from M/s Konduskar India, the Board recommended for also
involving trade bodies and diplomatic channels for taking up the matter with the Indian
authorities.
8133.
Ministry of Commerce may be approached with the recommendation that a cautious approach
made may be adopted for granting Most Favored Nation (MFN) status to the India in view of the
substandard imports.
8134.
A committee with following composition is constituted to thoroughly investigate the matter and
submit its finding and recommendations to the Board on priority basis.
a. Representative from DRAP
b. Representative from the Government of Punjab
c. Two Experts in Pharmaceutical Sciences
d. Any other co-optive member the committee may require
8135.
Suspension of registration of Tyno SF Cough Syrup of M/s Reko Pharmacal till completion of
investigation and decision by the competent forum.
8136.
Suspension of registration of Dextromethorphan Cough Syrup and Cocil Syrup of M/s Ethical
Labs till completion of investigation and decision by the competent forum.
8137.
8138. In consequence of the orders of DRB, following committee was
constituted by CEO DRAP.
8139.
8140.
8141.
8142. Design
735
ation
8143.
8144.
S
8146.
8147.
P
8145. Membe
r Appellate
Board
Chairman
Committe
e
8148. Membe
r
8149.
8150.
P
8151. Membe
r
8152.
8153.
M
8155.
8156.
D
8154. DDG,
Secretary/
Coordinat
or of the
Committe
e
8157. Membe
r
8158.
8159. The above committee has sent a report for the registration board
to considered the conclusion of the report is reproduce here under
for kind information of DRB.
8160. The committee in its report based on to the facts, findings, review of documents, analysis of
different reports and discussions based on scientific facts the committee has reached the conclusion
that suspected batches of the products i.e. Tyno SF cough syrup and Dextromethorphan cough syrup
manufactured by M/s. Reko Pharmacal, Lahore and M/s Ethical laboratories Lahore respectively
meet the Pharmacopoeal requirements, hence, these firms cannot be held responsible for the loss of
precious lives which occurred in two incidents. The deaths are attributed to overdosing of
Dextromethorphan and combining of other narcotic CNS depressants/noxious substances with the
Tyno SF syrup and Dextromethorphan syrup.
8161.
8162. The case along with the committee report was placed before
245th meeting of Registration Board. The Board discussed the case
at length and decided as under:8163. Registration Board decided that Mr. Jamil Anwar Member of the Registration
Board, Deputy Director General (E&M) Lahore&Islamabad will furnish the pending status
736
of these petitions filed by M/s Ethical laboratories Pvt Ltd and M/s Reko Pharmacal Lahore
for consideration of the Board in its up-coming meeting.
8164. The case was again placed before registration board in its 246 th
meeting who decided the case as under:8165. Registration Board again decided that Mr. Jamil Anwar Member of the Registration
Board, Deputy Director General (E&M) Lahore&Islamabad will furnish the pending status
of these petitions filed by M/s Ethical laboratories Pvt Ltd and M/s Reko Pharmacal Lahore
for consideration of the Board in its up-coming meeting.
8166. The Registration Board in its 246 thmeeting decided the case as
under:8167. Decision:- Registration Board again decided that Mr. Jamil
Anwar Member of the Registration Board, Deputy Director General
(E&M) Lahore&Islamabad will furnish the pending status of these
petitions filed by M/s Ethical laboratories Pvt Ltd and M/s Reko
Pharmacal Lahore for consideration of the Board in its up-coming
meeting
8168. The Director DTL Lahore Mr Jamil Anwer also the member of
registration Board informed in writing that these Firms have
withdrawn their Writ Petitions at Lahore.
8169. The case was considered by the Registration Board in its 248 th
meeting held on 18th-19th March, 2015.
8170. 2.
under:-
The Board, in view of the case background decided as
8171. Decision:
Registration Board discussed the matter at length in the light of above
proceedings of the case. Mr. Jamil Anwer, Director DTL Lahore showed his reservations on the
report of the Committee with the following observations as under:i.
The panel does not have any of the members from the Government of the Punjab, Health
Department.
8172.
8173.
ii. The adverse reports of DTLs Punjab, Appellate laboratory NIH, Islamabad,
8174. HEJ & laboratories of UK (MHRA) has not been reflected in the panel /Committees
report.
8175.
8176.
iii. Mr. Jamil Anwer Director DTL Lahore further apprised the Board that he had been
part of the proceedings in instant case when this sad incident happened and will share the
factual position of the case before Registration Board.
737
8177.
8178.
iv. Mr. Jamil Anwer Director DTL Lahore was asked by the Board to send the
documentary evidences of facts of this case to Secretary Registration Board, so that same
may also be incorporated.
8179.
v. The matter is deferred for next meeting of Registration Board.

8180. The Honorable Member of the Board (Mr. Jamil Anwar Director
DTL Lahore) has not furnished documentary evidences of facts of
this case.
8181. Accordingly
the
case
is
submitted
consideration/appraisal/decision by the Board.
again
for
8182.
8183. Case No.10: MANUFACTURE AND SUPPLY OF SUBSTANDARD HEPAFERON INJECTION BY
M/S
PHARMEDIC LABORATORIES (PVT) LTD , LAHORE- TO
GOVT OF KHYBER PAKHTOON KHAWA
8184.
Registration Board in its 248h meeting held on 18 th and 19th March 2015 considered the
case of M/s Pharmadic Laboratories (Pvt) Ltd Lahore.

8185. Background: The background of the case is that the
Registration Board in its 248th meeting held on 18th-19th March,
2015 discussed the case of supply of sub-standard Hepaferon
Injection (Interferon) to Government of Khyber Pakhtunkhawa
Batch No.80-87. The Federal Inspector of Drugs (FID) Peshawar
was directed bythe Registration Board to submit the certified copies
of decisions of Drug CourtPeshawar and Peshawar High Court,
Peshawar in the instant case. The FID has submitted the copies of
the orders the Peshawar High Court, Peshawar and the copies of
decision of Drug Court Khyber Pakhtunkhwa, Peshawar The Board
after thorough deliberations and in the light of decisions of the
Courts and view point of the member from the M/o Law Justice and
Human Rights decided the case as under:8186. Registration Board was briefed about the background of the
case. SheikhSarfraz Ahmad, representative from Ministry of Law
was of the view that after the decision of the Drug CourtPeshawar
738
a fresh reference requires to be sent to Law Division for seeking

opinion. The Board agreed to the proposal.
8187. Decision:
The Drugs Registration Board decided that the
opinion of Law Division may be solicited in the light of decision
of the Drug Court, Khyber Pakhtunkhawa, and Peshawar which
are self explanatory in which the Honorable Drug Court ordered
that the complaint of the prosecution is dismissed.
8188.
Keeping in view of the decision of the Drug Court
Khyber Pakhtunkhawa, Peshawar the M/o Law Justice and Human

Rights has been requested to furnish view/ comments as whether the
responsibility fixed by Federal Inspector of Drugs, Peshawar under
Section 23(1)(a)(v)(vii) and 23(1)(a)(vii), 23(1)(b)(f) of Drugs Act,
1976 for prosecution may be set aside after the decision of the Drug
Court Khyber Pakhtunkhawa, Peshawar or otherwise.
8189. Accordingly a U.O note to Ministry of Law & Justice has been
forwarded for taking comments on the subject issue. The comments
are awaited
8191.
Case No.11: Manufacture and Sale of Sub-Standard Stearox 1ml Injection Batch
No. H110112 M/s Gyton Pharmaceutical Lahore
8192. The Brief about the background ofthe case is as under:8193. The samples of Stearox Injection Batch No. H110112, Mfg by
M/s Guyton Pharmaceutical Lahore drawn by FID Karachi from
Central Pharmacy of JPMC, Karachi on 26-02-2013, was declared
Substandard vide test report No.261/2013 dated 03-04-2013 by
Federal Government Analyst. The FID has identified following
persons responsible in the case.
8194.
Mr. Talat Ahmad Anjum

8195. .
(Q.C In-charge)
Muhammad Imran Khalil
(Production In-charge)
8196.
739
As per procedure show cause notices was issued to the firm 20th February 2014 and above accused,
offering opportunity of personal hearing before the Drug Registration Board. They were also called for
personal hearing accordingly.
8197.
8198.
The case was placed before 244th meeting of Registration Board which decided the case as under:8199. The accused of the firm were called for personal hearing, but
they could not appear before the Board. The Board decided to defer
the case and a final opportunity of personal hearing shall be given in
next meeting of the Board
8200.
8201. The case was again placed before 245 th meeting of Registration
Board wherein accused as identified by FID Lahore were also called
for personal hearing accordingly. The Board decided the case as
under
8202.
Decision:Mr. Muhammad Salman Ali, Advocate High Court appeared on behalf of

M/s Guyton Pharmaceutical Lahore. The Board did not accept power of Attorney on
behalf of the firm. The Board decided the case as under:8203. i. The production of the injection Stearox 1ml Registration No.
040336 shall be stopped. One more opportunity of personal hearing
is granted with the direction that the Management and Technical
Personnel shall appear before the Board failing which the ex-parte
decision shall be taken.
8204. ii. The Board further decided that the firm will recall all the
marketed batches of sub-standard drugs from distribution / sale
outlets / institutional supplies if any and area FID shall take report
from the firm and submit a compliance report to Chairman
Registration Board.
8205. iii. One more opportunity of personal hearing was granted by the
Board with the direction that the Management and Technical
Personnel shall appear before the Board failing which the ex-parte
decision shall be taken.
8206.
The case was presented before the Registration Board agin in its 246 th meeting on 11-12-
2014. The Board decided the case as under in the light of personal hearing of Mr. Bilal Khurshid Chief
Executive of the firm:740
8207. Decision:i
The Board took the following decision:-
The area FID Mr. Abdul Rasool Shiekh to take the samples of the batch and submit the
investigation report of the case again as the firm has disowned the supply of specific Batch.
8208.
ii
The production of the firm in the steroidal Injectable section shall be stopped along with
suspension of registration of Stearox 1ml Registration No. 040336 which had already been
suspended in 245th Meeting till investigation of the case is finalized.
8209.
iii
The firm will be asked to provide on stamp paper regarding their statement of disowner
ship of supply of this batch.
8210.
iv
The case will be submitted before the Registration Board after completing the investigation.
8211.
8212. The undertaking on stamp paper has not submitted by the firm.
Mr. Abdul Rasool Sheikh, the area FID submitted the following
recommendations vide is report received on 28-01-2014:i
The document submitted by the supplier contained some vital information including evidence
of the payments made, case memos, delivery challan and more then this the authority letter
given by the manufacturer to M/s Al-Amin Sukkur for institutional supply.
8213.
ii
On the other hand the manufacturer not submitted the sale record that particular batch No.
H110112 and other information that was sought by the under signed (FID).
8214.
iii
Amid this situation the FID has recommended that both the parties may be called for
personal hearing into the up-coming meeting of Registration Board so that facts may be
further disclosed in front of the Board and then in the light of discussion decision may be
made.
8215.
8216. The case was again submitted before 248 th meeting of the Board
which could not heard the case due to paucity of the time and
deferred the case till next meeting of the Board.
8217.
8218. The case is again submitted for consideration of the Board.
8219.
8220.
Case. No.12: Supply of Substandard/Adulterated Injection Ofcil 100ml to DHQ

Hospital Hafizabad (25000 vials and M/s Medisearch Pharma Pvt Ltd 5Km Raiwind
Manga Road Lahore which supplied Almajax 250ml Suspension to DHQ Hospital
Hafizabad (35600) Bottles
741
8221.
The Secretary Provincial Quality Control Board (PQCB) Punjab Mr. Tallat Farooq Ahmad has
forwarded two recommendations to DRAP as under:8222.
i.
The Federal Government Cancel the Drug Manufacturing License of M/s
Mediceena Pharma, (Pvt) Ltd., 27-KM Raiwind Road Lahore on supply of Substandard / Adulterated injection Ofcil 100ml to DHQ Hospital Hafizabad (25000
vials) and M/s Medisearch Pharma (Pvt) Ltd., 5-KM, Raiwind Manga Road,
Lahore which supplied substandard Almajax 120ml Suspension to DHQ Hospital
Hafizabad (35600 bottles).
8223.
ii.
The Federal Government Cancel the Registrations of the said drugs of M/s
Mediceena Pharma, (Pvt) Ltd., 27-KM Raiwind RoadLahore and M/s Medisearch
Pharma (Pvt) Ltd., 5-KM, Raiwind Manga Road, Lahore.
8224.
8225. Brief Background:
8226.
The Provincial Quality Control Board (PQCB) after
scrutiny of the report of Government analyst i.e report Nos. TRA.

22863 & 22864 dated 21-11-2014 Batch No. JX168 of Almajax
suspension, and statement of the Drug Inspector observed that this
is a criminal negligence on the part of manufacturers and gross
loose in GMP compliance. The Punjab Government (PQCB)
observed that there is a dire need to take quick action against the
said firms to safeguard the public health at large and submitted the
above mentioned recommendations.
8227.
The case is placed before Registration Board for
decision on the recommendations of (PQCB) Punjab by

Registration Board regarding cancellation of Registrations of Drugs
of these firms as per law with the proposal that recommendations
may also be send to Division of Licensing for further necessary
action at their end so that public health may be saved from risk.
8228. Decision of Registration Board:a. To get the complete investigation along with all the reports and case
background from the Secretary Provincial Quality Control Board Health
Department Government of Punjab Lahore through the DDG (E&M) Lahore.
b. The area FID Lahore will be asked to submit the case background in writing
along with all relevant reports for perusal of the Registration Board for decision.
8229.
742
c. The Board further decided the case shall be forwarded to Directorate of

Licensing for further necessary action in the light of recommendation of the
Provincial Quality Control Board (PQCB) Punjab.
8230.
8231. The decision/reminders have been again conveyed to DDG
(E&M) Lahore and FID Lahore the report is awaited.
8232.
Submitted for appraisal/consideration of the Registration Board.
8233.
743

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Agenda 249th Registration Board Meeting

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Agenda for 249th Meeting Registration Board to be held on 18-19th May, 2015.

Confirmation of minutes of 248th meeting Registration Board

Cases referred by Pharmacy Services Division

Cases referred by Pharmaceutical Evaluation & Registration Division

Cases referred by Biological Evaluation & Research Division

Cases referred by Quality Assurance & Lab Testing Division

Item No. I: Confirmation of minutes of 248th meeting Registration Board.

Antimicrobial resistance is resistance of a microorganism to an antimicrobial drug that

Infections caused by resistant microorganisms often fail to respond to the standard

resistant Staphylococcus aureus, another common source of severe infections in the

Antimicrobial resistance is a major concern to the public health, threatening the

Making antimicrobial resistance a core component of professional education,

The incidence, prevalence, range across pathogens and geographical; patterns

Objective 4 : Optimize the use of antimicrobial medicines in human and animal

Data on antibiotic use will be collected and analyzed in Provinces to develop a

Polio End-game strategies-Poliovirus Type 2 challenge study. A Five Arm

World Health Organization (Geneva)

Syed Sohail Zahoor

It is hereby informed that the subject study is well planned to

Case No. 03: Recombinant Bovine Growth Hormone (rBGH or rBST)

Canada and European Union Bans on rBGH Use:

Pharmaceutical Evaluation & Registration Division.

Case No.03: Guidelines on stability studies

Long Term stability (5C 3 C)

One Lab scale batch.

Lab scale trial batch:

Dry Suspensions / Sachets (Oral)

Qty. Per Test

Dry Powder Injections

Cream / Ointment / Gel

Liquid Syrup / Suspension

Pre-Filled Syringe (PFS)

Pilot Batch (10% of Commercial Batch)

Frequency of tests (Accelerated) 0, 1,

Dry Suspensions / Sachets

Dry Powder Injections

Import of raw material:

Submitted for consideration of the board.

Case No. 04: Registration applications of new drug manufacturing licenses

Aqua Pro Injection

Each 2ml contains:

BNF : Water for

Each 2ml contains:

1.Me-too status not confirmed.

& strength not provided/not

2.Me-too status not confirmed.

Optinac Eye Drops

Optiket 0.5 % Eye

Local: Visol Gel

Optim Eye Drops

price Rs. 190.0

Rs. 20,000/As Per SRO

CEFOXIL Oral dry

CEFOXIL Oral dry

Rs. 20,000/As Per SRO

for finished product

for finished product

for finished product

& strength not provided/not

for finished product

for finished product

for finished product

1.Potentiometer is required for

Canada, TGA & MHLW for