PROJECT REPORT ON

ACTIVE PHARMACEUTICAL INGREDIENTS

IN AARTI LIMITED.

SUBMITTED BY:
ASMA ISAQ BOBADE
T.Y.B.M.S.

SEMESTER V

ACADEMIC YEAR: 2009-10

PROJECT GUIDE:
PROF. MEHTAB AHMED

SUBMITTED TO:
UNIVERSITY OF MUMBAI

BURHANI COLLEGE OF COMMERCE & ARTS,

NESBIT ROAD, MAZAGAON,

MUMABAI-400010.
 PROJECT REPORT ON

ACTIVE PHARMACEUTICAL INGREDIENTS

IN AARTI LIMITED.

SUBMITTED TO THE UNIVERSITY OF MUMBAI

IN THE PARTLY FULFILLMENT FOR THE DEGREE
OF BACHELOR OF MANAGEMENT STUDIES.

BY:
ASMA ISAQ BOBADE

PROJECT GUIDE
PROF. MEHTAB AHMED

BURHANI COLLEGE OF COMMERCE & ARTS,

NESBIT ROAD, MAZAGAON,

MUMABAI-400010.

UNIVERSITY OF MUMBAI

DECLARATION
I, Mrs,Asma Isak Bobade, a student of Burhani College of
Commerce And Arts, Nesbit Road, Mumbai-400010, studing
in T.Y.B.M.S.(semester ) hereby declare that I have
completed this project “Manufacturing of Active
Pharmaceutical Ingredient in Aarti Ltd” during the academic
year 2009-2010.The information submitted is true and
original to the best of my knowledge.

Date:

Place: Mumbai Signature of student

ACKNOWLEDGEMENT
 I would like to express my sincere gratitude to my professor guide Prof.
Mehtab Ahmed, for his invaluable inputs, uncompromising support &
constructive criticisms without which this project would not have been
completed.

I would like to thank my parents for their constant support. I would also
like to thank my friends for their support. My sincere thanks, to the
University of Mumbai and my college for giving me an opportunity to
release this project which helped me gain a persona study of management
with due official recognition.

I would also thanks the co-ordinator of the B.M.S. faculty, Prof. Mrs.
Waris for the help that she provided during the course of the year in her
capacity as the Head of the Department.

To the college Dean & the entire administrative staff, especially the library
staff for being so helpful in selecting various relevant books & magazines
which were of great help in selecting the right materials.

I sincerely thank them all.

EXECUTIVE SUMMARY
Over the last 15 years, the pricing and other competitive strategies of pharmaceutical
companies have been altered by revolutionary developments in information technology, new
state drug substitution laws, federal legislation, and the emergence of market institutions that
include health maintenance organizations (HMOs) and pharmacy benefit managers (PBMs).
The industry has also undergone significant structural changes that include growth of the
generic drug segment and substantial horizontal and vertical consolidation (e.g., acquisitions
of PBMs by drug companies) by drug companies. This report first examines these
institutional and structural changes, and then focuses on the nature of competition in the new
environment. The purpose of the report is to identify and discuss both possible antitrust
concerns and plausible procompetitive explanations of the emerging pricing and other
competitive strategies of pharmaceutical companies in this changing environment. Definitive
conclusions on whether particular strategies are anticompetitive, competitively neutral, or
procompetitive are likely to involve facts specific to these strategies and must await further
study. This report is intended as an initial step in developing a more complete understanding
of the competitive dynamics of pharmaceutical markets subject to ongoing informational,
institutional, and structural changes.

The report covers four primary areas of analysis. First, the report examines how information
technology has altered competition among drug companies. Less than two decades ago, the
information flows in the prescription drug industry were relatively simple. A pharmacist
would fill each prescription as specified by the doctor, unless the patient was willing to
accept a generic substitute. Retail pharmacies would manually order drugs from drug
wholesalers, who would deliver the product and replenish their own inventories with drugs
ordered from pharmaceutical companies. Physicians obtained drug information from reports
on clinical trials published in medical journals and distributed by drug company salesmen, or
in their regular practice by observing the success or failure of drugs prescribed for their
patients. Competition among drug companies was focused on gaining the allegiance of
prescribing physicians.

More recently, as described in the report, the doctor's prescription has become just the
starting point in determining what drug the pharmacist dispenses. Today, pharmacies are
typically part of PBM networks that administer the drug benefits portion of health insurer
plans for employers and others. Computers linking network pharmacies to PBMs enable
pharmacists to check which brand name or generic substitutions are required by the patient's
health insurer, whether the doctor is prescribing according to health plan policy, what co-
payment amount applies, and when drug stocks are low. The same computer technology
allows pharmacies to manage their drug inventories. The drug dispensing records of
pharmacies are increasingly being used to develop new products and services. Most
importantly, prescription drug usage and cost information can theoretically be merged with
the patient care records of doctors and hospitals, conceivably placing significant numbers of
patients in large, possibly nationwide clinical trials for existing prescription drugs. Through
disease state management (DSM), the firms administering prescription drug insurance plans
can learn more than was previously known about how well various drugs work, both relative
to other drugs and to non-drug therapies. This information enables insurers and other drug
buyers to focus more attention on comparisons of drug alternatives and their prices. While the
traditional focus was on gaining the allegiance of prescribing physicians, drug companies
now also compete for placement in health plan protocols and for contracts with HMOs.

The competitive implications of key contract provisions, including most-favored-nation

(MFN) and volume-based rebate provisions, are addressed in this report. In addition to
efficiency explanations for these provisions, their possible use as devices to raise prices is
considered. For example, volume discounts in drug company contracts with HMOs could
induce them to maximize their rebates by transacting exclusively with those companies
offering the most attractive terms. Exclusive dealing arrangements like this might force
competing drug companies to use more costly means of marketing their drugs or could
otherwise foreclose competition among them. The report outlines the conditions under which
such vertical contract provisions may lead to higher prices. These require an assessment of
the marketing alternatives available to rivals and an evaluation of conditions of entry in drug
and other downstream markets. Similar foreclosure analyses are applied to examine the
competitive implications of PBM acquisitions by pharmaceutical companies.

OBJECTIVE OF PROJECT WORK

 To show the Manufacturing functions for production of API Drugs.

 To show the manufacturing of API Drugs.

 To show the ingredients used in manufacturing of API Drugs.

 To show the functioning under taken by every Department in manufacturing of

API Drugs.

 To show the sale of the API Drugs.

 To show the huge technology used in production of API Drugs.

 To show how qualified organization work for a production of API Drugs.

 To show the involvement of department for proper handling of API Drugs.

 To show the safety precaution taking care while manufacturing of API Drugs.

TABLE OF CONTENTS
1) INTRODUCTION ……………………………………………………………………2

2) HIGHLIGHTS OF AARTI GROUPS..…...………………………………………….5

3) RESEARCH & DEVELOPMENT FOCUS………………………………………….6

4) LIST OF API PRODUCT’S…………………………………………………………8

5) MANUFACTURING OF API PRODUCT …………………………………………9

6) DESCRIPTION OF MANUFACTURING FACILITY ……………………………11

7) BRIEF PROCESS DISCRIPTION …………………………………………………16

8) PRODUCTION SYSTEM……………………………………………………………24

9) TECHNOLOGY USED FOR PRODUCTION OF API DRUGS …………………26

10) PACKAGING ………………………………………………………………………32

11) WAREHOUSING…...………………………………………………………………35

12) SALE………. ……………………………………………………………………….40

13) QUALITY SYSTEM ……………………………………………………………….43

14) VENTILATION SYSTEM…………………………………………………………54

15) WATER SYSTEM …………………………………………………………………55

16) MAINTAINCE SYSTEM ………………………………………………….………56

17) HYGIENE SYSTEM …………….……..………………………………….………57

18) SAFETY, HEALTH & ENVIROMENT..………………………………….………58

19) HR DEPARTMENT.……………………………………………………….………70

20) MILESTONES…….……………………………………………………………….72

21) REASEARCH & METHODOLOGY …………………………………………….73

22) CONCLUSION …..……………………………………………………………….74

23) BIBLOGRAPHY….………………………………………………………………75