DUC-Z PHARMACEUTICALS#IX
BEGIN:LTO;CDRR;DUC-Z
PHARMACEUTICALS#IX#Wholesaler#0;RNW
#0#0#1#0#0####0;10000;100;36000;461
00:END
IMPORTANT
READ THIS PAGE
CAREFULLY.
Provide information only
when asked for.
rinting Instructions
PAGE
.
ormation only
d for.
ages 1 and 4.
ages 1 and 3.
ages 1 and 2.
age 1 only.
APPLICATION F
1 GENERAL INFORMATION
PROCEED
GENERAL INFORMATION:
ESTABLISHMENT INFORMATION:
PRODUCT INFORMATION:
SUPPORTING INFORMATION:
SOURCES & CLIENTS:
APPLICANT INFORMATION:
ORDER OF PAYMENT
Amount Due: Php
Fee : Php
Legal Research Fee : Php
Surcharge : Php
OR Number :
Date Paid:
TURNED INITIAL
03 Oc
CDRR-RIX-DW-148
03-Jul-15
NO
4 SUPPORTING INFORMATION
PROCEED
2.6.1 Region: IX
2.7.0
2.7.1
2.7.2
2.7.3
E-mail Address:
Contact Detail 1
Contact Detail 2
Contact Detail 3
robert.dampor@yahoo.com
Landline:
Mobile:
Fax:
NA
9177262049
NA
PROCEED
License to Operate
I. The said establishment shall be open for business hours under the su
II. The pharmacist and other allied health professionals, upon and durin
other FDA-regulated establishment (if applicable);
IV. To change the business name of the establishment and/or brand nam
Drug Administration, or if the FDA rules later that it is misleading;
a. Have filed the application, and have paid the complete & appropria
X. Any violation of the above provisions and rules and regulations will a
Operate.
XI. I/We make this declaration in full knowledge and awareness of Repu
Administration Act of 2009, other allied laws and their implementing rul
Socia
CLIENTS
ON FORM 51SOURCES &None
m. Without the
STATUS
ATION: PROCEED
ATION: PROCEED
ATION: PROCEED
ATION: PROCEED
IENTS: PROCEED
ATION: PROCEED
Php
hp
hp
hp
46,100.00
10,000.00
100.00
36,000.00
03 October, 2015
ATION
Add or
Delete?
PROCEED
PROCEED
PROCEED
6 APPLICANT INFORMATION
The undersigned attest to have provided true and complete information in this fo
requirements at the time of submission. The undersigned agree to strict complia
Food and Drug Administration (FDA), including Good Manufacturing Practice (GM
(GDSP), Good Pharmacy Practice (GPP), and/or Good Laboratory Practice (GLP). F
authority to the FDA to verify the truthfulness of the information provided with th
6.1.2 Designation:
6.1.3 Tax ID Number:
6.1.4.0 Type of Gov't ID:
6.1.4.1 ID Number:
6.1.4.2 Date Expiry:
6.2 APPLICANT
6.1.1.0 Family
Name:
6.1.1.1 First
Name(s):
6.1.1.2 Middle
Name:
DAMPOR
ROBERT TITO
IBAEZ
PROCEED
6.2.2 Designation:
6.2.2.0 Family
Name:
6.2.2.1 First
Name(s):
6.2.2.2 Middle
Name:
AGOT
LILIA
TACLOB
Company Pharmacist
204-557-030-000
Professional Regulatory Commission
20092
28-Jul-15
PETITION
DUC-Z PHARMACEUTICALS
during employment in this establishment, is/are not and will not in any wa
nd name of products in the event that there is a similar or same name regis
the LTO application are the exact duplicate of the hard copy and, any discr
round for disapproval of application and/or the filing of legal action against
since the last renewal of LTO specifically but not limited to change of locat
ange in warehouse site, additional supplier and product lines, change in act
otice to the FDA of the change in business address, business name, owners
ound for revocation of the License to Operate;
Republic Act No. 3720, as amended by Republic Act no. 9711, otherwise k
ing rules and regulations.
WAIVER
ACKNOWLEDGEMENT
Expiry Date of ID
NA
Professional Regulatory
Commission:20092
28-Jul-15
___________
___________
ute the application form and this petition form, and they acknowledged to
n the date and place first above written.
1)
2)
3)
4)
5)
6)
7)
8)
9)
API
API
API
API
API
API
API
API
API
Manufacturer,
Manufacturer,
Manufacturer,
Manufacturer,
Manufacturer,
Manufacturer,
Manufacturer,
Manufacturer,
Manufacturer,
Address
Address
Address
Address
Address
Address
Address
Address
Address
Address
Address
Address
Address
Address
Address
Address
Address
Address
Address;
Address;
Address;
Address;
Address;
Address;
Address;
Address;
Address;
1)
2)
3)
4)
5)
6)
7)
8)
9)
API
API
API
API
API
API
API
API
API
Supplier,
Supplier,
Supplier,
Supplier,
Supplier,
Supplier,
Supplier,
Supplier,
Supplier,
Ad
Ad
Ad
Ad
Ad
Ad
Ad
Ad
Ad
PROCEED
PROCEED
nt
on
nes.
horized personnel;
at we assume primary
NT AND PRIVATE
__
Place Issued
_________________________
_________________________
the
, and
s
plier,
plier,
plier,
plier,
plier,
plier,
plier,
plier,
plier,
Address
Address
Address
Address
Address
Address
Address
Address
Address
Address
Address
Address
Address
Address
Address
Address
Address
Address
Address;
Address;
Address;
Address;
Address;
Address;
Address;
Address;
Address;
Department of Health
Food and Drug Administration
APPLICATION
FORM
1 1 0 0 0 0 0 SOURCES & CLIENTS:
1
1
1
1
1
Drug
1.2 Authorization:
License to Operate
1
0
0
1
PRO 1
0
1
1
1
0
1
Description (Optional):
0
2 ESTABLISHMENT INFORMATION
1.4 Primary Activity:
2.1 Name of Establishment
Wholes
DUC-Z PHARMACEUTICALS
1.3 Type:
Renewal
2.3 Tax Identification Number:
2.4 Office Address
TURNED INITIAL
0
0
E-mail Address:
Contact Detail 1
Contact Detail 2
Contact Detail 3
robert.dampor
Landline:
Mobile:
Fax:
0
1
0
1
0
1
0
0
0
1
1
Type of Amendment:
Source: Add/ Delete FAL
Page 40 of 78
1
Other Amendments
License to Operate
1
TRU 1
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Department of Health
Food and Drug Administration
Source: Change of BuFAL
Change of Importer/ DFAL
Product Registration FAL
License to Operate TRU
0
0
0
1
1
0
APPLICATION FORM
0 1
FAL
Reclassification
0 Activity: Additional
FAL
FAL
Finished Product
FAL
Raw Material
Free Sale, Certificate FAL
Pharmaceutical Product
FAL
Export Certificate
FAL
FAL
Product Line
ORDER OF PAYMENT
Amount Due:
Fee :
Legal Research Fee :
Surcharge :
OR Number :
Date Paid:
Computation Valid Until:
6 APPLICANT INFORMATION
0
0
0
0
0
0
Php
1
1
46100
10000
100
36000
The undersigned attest to have provided true and complete information in this form, and to provide com
the time of submission. The undersigned agree to strict compliance with the rules and regulations of the
Administration (FDA), including Good Manufacturing Practice (GMP), Good Distribution and Storage Pract
Pharmacy Practice (GPP), and/or Good Laboratory Practice (GLP). Further, the undersigned agree to gran
verify the truthfulness of the information provided with this application.
Signature
6.1.1.0 Family Na DAMPOR
6.1.1.1 First Name(ROBERT TITO
Latest photo of applicant
6.1.2 Designation:
6.1.3 Tax ID Number:
6.1.4.0 Type of Gov't ID:
6.1.4.1 ID Number:
6.1.4.2 Date Expiry:
6.2 APPLICANT
Signature
6.2.2.0 Family Na AGOT
6.2.2.1 First Name(LILIA
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Department of Health
Food and Drug Administration
Latest photo of applicant
6.2.2 Designation:
6.2.3 Tax ID Number:
6.2.4.0 Type of Gov't ID:
6.2.4.1 ID Number:
6.2.4.2 Date Expiry:
Page 42 of 78
APPLICATION
FORM
6.2.2.2 Middle Na TACLOB
Company Pharmacist
204-557-030-000
Professional Regulatory Commission
329986351.xlsx
NA
6.2.6.1 Contact De
Landline:
6.2.6.2 Contact De
Mobile:
20092 6.2.6.3 Contact De
42213 Fax:
09/17/2016 15:44:53
Department of Health
Food and Drug Administration
License to Operate
APPLICATION FORM
This form is the second page of a two-page application form for licensing by the Food and Drug Admi
PETITION
I/we am/are duly authorized to affirm the following declaration on behalf of the Company:
I. The said establishment shall be open for business hours under the supervision of PRC registered profe
II. The pharmacist and other allied health professionals, upon and during employment in this establishm
III. The approved and valid License to Operate shall be displayed in a conspicuous place of the establish
IV. To change the business name of the establishment in the event that there is a similar or same name
V. The attached electronic copy of files/documents/information of the LTO application are the exact dupli
VI. If applying for automatic renewal:
a. Have filed the application before expiry date;
b. Have paid the renewal fee prior its expiry date;
c. That there are no unapproved changes or variations whatsoever in the establishment since the las
VII. The products we manufacture, distribute or sell are registered or to be registered with FDA prior to d
VIII. The establishment whether for initial, renewal or automatic renewal, is still subject to inspection by
IX. Non-compliance
with the requirements329986351.xlsx
and/or failure to give notice to the FDA
of the change
in busin
Page
43 of 78
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Department of Health
Food and Drug Administration
APPLICATION FORM
IX. Non-compliance with the requirements and/or failure to give notice to the FDA of the change in busin
X. Any violation of the above provisions and rules and regulations will automatically be subject to the SU
XI. I/We make this declaration in full knowledge and awareness of Republic Act No. 3720, as amended b
WHEREFORE, the undersigned confirm the truth of our declaration and awareness of the foregoing duties
WAIVER
I HEREBY GRANT AUTHORITY TO THE FOOD AND DRUG ADMINISTRATION TO VERIFY THE AUTHENTICITY O
ACKNOWLEDGEMENT
2)
Known to me and to me known to be the same persons who execute the foregoing instrument consistin
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Department of Health
Food and Drug Administration
APPLICATION FORM
Series of : _____________________________
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Food and Drug Administration
APPLICATION FORM
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Food and Drug Administration
APPLICATION FORM
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Food and Drug Administration
APPLICATION FORM
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Food and Drug Administration
APPLICATION FORM
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Food and Drug Administration
APPLICATION FORM
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Department of Health
Food and Drug Administration
APPLICATION
FORM
4 SUPPORTING INFORMATION
Add or Del
0
1
1
1 PRO
Wholesaler
1
403-376-459-000
2.5.1 RegioIX
1
OG CITY
2.6.1 RegioIX
1
OG CITY
1
1
1
dampor@yahoo.com
e:
NA
9177262049
NA
1
1
1
1
1
Drug
Food
0
0
1
1
1
1
1
1
HUHS
Device
None
0
1
0
0
1
0
0
0
0
Page 51 of 78
1
1
1
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Department of Health
Food and Drug Administration
0
0
Php
APPLICATION FORM00 1
None
1
1
0
1
1
1
1
1
1
0
01
None
1
0
1
de complete requirements at
s of the Food and Drug
ge Practice (GDSP), Good
to grant authority to the FDA to
ng Address
1
1
1
1
0
01
None
1
0
1
ng Address
1
1
1
1
0
01
None
1
0
1
Page 52 of 78
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Department of Health
Food and Drug Administration
APPLICATION FORM
ntact Detail 1
NA
ntact Detail 2
1
1
1
1
9161479762
ntact Detail 3
NA
Page 53 of 78
0
01
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Department of Health
Food and Drug Administration
APPLICATION FORM
ablishment, is/are not and will not in any way be connected with any other FDA regulated establishment (if a
stablishment;
e name registered with the Food and Drug Administration or if it rules later that it is misleading;
ct duplicate of the hard copy and, any discrepancy/ prejudicial contents or wilful misrepresentation on any o
e the last renewal of LTO specifically but not limited to change of location, change of ownership, change of bu
tion by FDAs authorized representatives at any reasonable time and undertake to respond and cooperate fu
in business
business name, ownership,
or any other circumstances in relation
to the approval
of thi
Page 54 address,
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Department of Health
Food and Drug Administration
APPLICATION FORM
in business address, business name, ownership, or any other circumstances in relation to the approval of thi
ended by Republic Act no. 9711, otherwise known as the Food and Drug Administration Act of 2009, other a
g duties and responsibilities among others, and prays that this application for License to Operate be granted
TICITY OF ALL THE DOCUMENTS SUBMITTED FROM BOTH GOVERNMENT AND PRIVATE RESOURCES.
owing :
Identification Number
Date Issued
Place Issued
_________________________
___________
__________________
_________________________
___________
__________________
consisting of 2 pages including the application form, and they acknowledged to me that the same is their fre
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Food and Drug Administration
APPLICATION FORM
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Food and Drug Administration
APPLICATION FORM
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Food and Drug Administration
APPLICATION FORM
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Food and Drug Administration
APPLICATION FORM
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Food and Drug Administration
APPLICATION FORM
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Food and Drug Administration
APPLICATION FORM
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Department of Health
Food and Drug Administration
1
APPLICATION FORM
1
PR
OC1
EE1
1D
PR1
OC
EE1
1D
1
PR1
OC1
EE1
1D
1
None
0
1
1
1
1
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Department of Health
Food and Drug Administration
0
1
APPLICATION
FORM
01
1
None
0
1
1
1
1
1
0
01
None
1
0
1
1
1
1
1
0
01
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1
0
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1
1
1
1
0
01
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0
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Food and Drug Administration
APPLICATION FORM
0
01
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1
1
1
1
1
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Department of Health
Food and Drug Administration
APPLICATION FORM
ooperate fully with the FDA with regard to any subsequent post-ma
roval
of this
is a ground for delisting
of the License to
Page
65 application
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Department of Health
Food and Drug Administration
APPLICATION FORM
09, other allied laws and their implementing rules and regulations
S.
ssued
_______________________
_______________________
is their free and voluntary act and deed. WITNESS MY HAND AND
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Food and Drug Administration
APPLICATION FORM
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Food and Drug Administration
APPLICATION FORM
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Food and Drug Administration
APPLICATION FORM
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Food and Drug Administration
APPLICATION FORM
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Food and Drug Administration
APPLICATION FORM
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Food and Drug Administration
APPLICATION FORM
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