The document is an industrial training report submitted by Jayesh Mohansing Rajput to fulfill requirements for a Bachelor of Pharmacy degree. It provides an overview of his training at Glenmark Pharmaceuticals Ltd in Nashik, India. The report describes Glenmark's history and facilities, including departments for documentation, production, quality control, and quality assurance. It also lists some of Glenmark's regulatory approvals and top-selling products.

1. INDUSTRIAL TRAINING REPORT
AT
GLENMARK PHARMACEUTICALS LTD
SUBMITTED TO
KAVAYITRI BAHINABAI CHAUDHARI NORTH MAHARASHTRA UNIVERSITY, JALGAON
In partial fulfillment of the requirement for award of
BACHELOR OF PHARMACY
SUBMITTED BY
Mr. JAYESH MOHANSING RAJPUT
Under valuable guidance of
ASST. PROF. R.N.CHAUDHARI
Assistant professor
Department of pharmacognosy
J.E.S.’S COLLEGE OF PHARMACY (DEGREE),
Waghoda road, NANDURBAR.

2. CERTIFICATE
This is to certify that the project entitled GLENMARK PHARMACEUTICALS LIMITED has been
completed by Mr. JAYESH MOHANSING RAJPUT for the partial fulfillment of final year B. pharmacy
course of KAVAYITRI BAHINABAI CHAUDHARI NORTH MAHARASHTRA UNIVERSITY,
JALGAON during the academic year 2019-2020 under the guidance of ASST. PROF. R.N.
CHAUDHARI at J.E.S’S COLLEGE OF PHARMACY, NANDURBAR. The dissertation is the record
of his own work and is now ready for evaluation.
Prof. R. N. Chaudhari Prof. R. S. Chaudhary
Training and Placement Officer Principal
J.E.S’S college of pharmacy, Nandurbar J.E.S’S college of pharmacy, Nandurbar
EXTERNAL EXAMINER
PLACE: NANDURBAR
DATE:

3. ACKNOWLEDGEMENT
Whenever we are standing on most difficult step of our life, we often remind about
the great god for his blessings and kind help and he always helps us in tracking of
the problems by some means in our life time.
I am grateful to those peoples who helped me in the preparation of this training
report. It is their support and blessings, which has brought me to write this training
report, I have deep sense of gratitude for them.
I am thankful to respected Mr. YOGESH SONAR (Sr. Manager-HR) for his hearted
support and affectionate encouragement without which my successful INDUSTRIAL
TRAINING would not have been possible. I am also thankful to department
headstand employees of GLENMARK PHARMACEUTICALS Ltd. Finally, I am very
grateful to all persons whose caring and loving support contributes a major share in
the completion of my work.
Thanks to all!!!
Mr. JAYESH M RAJPUT
(Final year B. pharmacy)

4. INDEX
SR
NO
CONTENTS PAGE
NO
1 INTRODUCTION 5
2 HISTORY 6
3 OBJECTIVES 8
4 REGULATORY APPROVALS 8
5 INDUSTRIAL LAYOUT 9
6 DOCUMENTATION DEPARTMENT 12
7 INSTRUMENTS DEVICES AND EQUIPMENTS 13
8 PRODUCTION DEPARTMENT 19
9 QUALITY CONTROL DEPARTMENT 20
10 QUALITY ASSURANCE DEPARTMENT 21
11 PRODUCTS 23
12 PERSONNEL AND ADMINISTRATION 24
13 CONCLUSION 24

5. 1. INTRODUCTION
Glenmark pharmaceutical is a pharmaceutical company headquartered in
Mumbai, India that was founded in 1977 by Gracias Saldhanha as a generic drug
and active pharmaceutical ingredient manufacturer; he named the company after
his two sons. The company initially sells its products in India, Russia, and Africa.
The company went public in India in 1999, and used some of the proceeds to
build its first research facility. Saldanha’s son Glenn took over as CEO in 2001,
having returned to India after working at Price water house coopers. By 2008
Glenmark was the fifth biggest pharmaceutical company in India.
By 2011 the founder of the company was one of the richest men in
India, and Glenmark had worldwide sales of $778 million, a 37% increase over the
last year’s sales; the growth was driven by Glen mark’s entry into the USA and
European generic markets. in the mid of 2010s the generics industry in general
began transitioning to the end of an era of giant patent cliffs in the
pharmaceutical industry; patented drugs with sales of around $28 billion were set
to come off patent in 2018, but in 2019 only about $10 billion in revenue was set
to open for competition, and less the next year. Companies in the industry
responded with consolidation or trying to generate new, patented drugs. Glenn
saldanha took the company down the path of seeking innovation, which was
controversial within the company and with shareholders. The company focused
on new drugs and biosimilars in the fields of cancer, dermatology and respiratory
diseases, which it sought to monetize by partnering with major pharmaceutical
companies. In 2016 it had four such drugs in clinical trials. For the financial year
2016-2017 its sales were around 81 billion INR (ca. $1.25 billion), making it the
fourth-biggest Indian pharmaceutical company. In May 2019, Yasir rawjee is
elected as CEO of Glenmark life sciences.

6. 2. HISTORY
1977:- The Company was incorporated on 18th, November, as “Glenmark
Pharmaceuticals Private Limited” under the companies act, 1956, and became a
deemed public company on July 1, 1990, the word private was deleted on July 1,
1991 and became a public limited company on January 12, 1996. The company is
engaged in research and development, manufacturing and marketing of
Pharmaceutical formulations, domestically as well as overseas. The company has
two brands i.e. ASCORIL EXPECTORANT and CANDID-B among the ORG top 300
leading pharmaceutical brands in India.
1979:- The Company entered the anti-fungal market, where competition was less
due to the relatively smaller market size, by introduction CANDID cream. The
company launched CANDID lotion. It also introduced CANDID V-3, CANDID V-1
and CANDID V-GEL.
1981:- The Company launched CANDID-B cream, a topical anti-fungal steroid
combination to target the hitherto untapped market.
1985:- CANDID mouth paint was launched for oral thrush, targeted as
pediatricians. The company launched ASCORIL, a cough expectorant, and it is one
of the most successful brands of the company and ranked 103rd
as per ORG Aug
’99-MAT.
1987:- The Company started a Research and Development department at its
NASHIK factory.
1990:- The Company launched CANDIDERMA and it is now the number two brand
in its segment with a market share of 6.6%.
1993:- The Company launched CANDID EAR DROPS.
1995:- The Company launched CANDID TV SUSPENSION and CANDIDTRAL.
1997:- The Company established a cardiac center at Dadar, in Mumbai.
1999:- Altacef, Suprocin, Suprocin B, Scalpe and Elovera were launched during the
year and have been the most successful product by the company, recording high
growth. The company has acquired three brands, viz. ALEX, FLUCORT and SENSUR
from LYKA LABS LTD.

7. 2003:- Fire breaks out at kurkum factory and manufacturing operations have been
suspended. The company ties up with APOTEX, Canada, for the supply of a new
generation bulk drug in cardiac segment. Glenmark pharmaceuticals Ltd acquire
two FDA approved products from CLONMEL healthcare Ltd.
2005:- Glenmark forges alliance with 2 US firms to sell products in US.
2006:- Glenmark pharmaceuticals- Glenmark USA acquires exclusive marketing
rights to 3 additional generic products.
2007:- Glenmark pharmaceuticals received tentative US FDA approval for its
ANDA for TOPIRAMATE tablet. Glenmark receives MHRA, UK approval for its
state-of-the art semi-solids manufacturing plant at baddi. Glenmark launches
NABUMETONE and HYDROXYZINE HYDROCHLORIDE tablets; Glenmark launches
CLOBETASOL from its niche dermatology pipeline. Glenmark launches
TRANDOLAPRIL tablets.
2010:- Glenmark pharmaceuticals Ltd has entered into a settlement and license
agreement with SEPRACOR INC to market generic eszopiclone tablets.
2011:- Glenmark wins two prestigious global recognitions at SCRIP awards in the
year 2011.
2013:- Glenmark announces launch of hydrocortisone butyrate cream in the US.
2016:- Glenmark pharma discovers new molecule.
2017:- Glenmark pharma launches nicotine substitute gum.

8. 3. OBJECTIVES
 To manufacture “WORLD CLASS PHARMA FORMULATIONS”
 To satisfy “NEEDS AND EXPECTATION OF CUSTOMERS”
 To ensure “EMPLOYEE INVOLVEMENT”
 To build “QUALITY AT EACH AND EVERY LEVEL”
 To assure “COMMITMENT TO SAFETY”
 To involved in “CONTINOUS IMPROVEMENT”
4. REGULATORY APPROVALS
WHO – GMP
ANVISA (BRAZIL)
NDA – UGANDA
MOH – ETHIOPIA
TFDA – TANZANIA
MOH – CONGO
MCC – SOUTH AFRICA
MOH – OMAN
MOH – UKRAINE
INVIMA – COLUMBIA
MARKETS:-
ASIA, INDIA, AFRICA, CIS/RUSSIA, LATIN AMERICA

9. 5. INDUSTRIAL LAYOUT
 Ground floor plan
GLENMARK PHARMACEUTICALS
NASHIK PLANT,
BY JAYESH RAJPUT
GROUND FLOOR PLAN
LOADING OF PACKED
PRODUCTS
FINISHED
PRODUCTS
SHAMP
OO UNIT
PACKING
DEPARTM
ENT
BLISTER
PACKIN
G
DUSTING
POWDER
UNIT
RECE
PTIO
N
PLANT
MANAGERS
OFFICE
CONFEREN
CE HALL
LIFT
AND
STAIRS

10.  Underground floor plan
Underground floor plan
Storage unit
Dusting
Powder
storage unit
Bulk drug
storage
Raw
material
storage
room
LIFT
AND
STAIRS

11.  First floor plan
FIRST FLOOR PLAN
LIFT AND
STAIRS
DOCUMENTATION
DEPARTMENT
QUALITY
CONTROL
DEPARTMENT
ENGINERING
DEPARTMENT
QUALITY
ASSURANCE
DEPARTMENT
STORAGE ROOM 2STORAGE ROOM 1
STORAGE
ROOM 3

12.  Nashik Plant image
6. DOCUMENTATION DEPARTMENT
Documentation department is on the first floor of the plant which regulates sop
of the following
o Usage and storage log book
o Assurance records
o Sampling of sent finished and finished product
o Control sample and stability sample record
o In process quality assurance (IPQC) in active pharmaceutical ingredient
section records
o Release of finished products for distribution
o BMR- batch manufacturing record
o BPR- batch packing record
o Master equipment list
o Status labeling
o Use of rubber stamp during documentation and data compilation

13. o Controlled copy
o Uncontrolled copy
o Reviewed and approved products
o Revalidated products
o Disposal or scrap products
o Assurance and deposition of batch documentation
o Allotment of the product batch number
o Procedure for product registration
o Expiry dating
o IPQC store department records
o Depot records
o Storage room records
o Receipts, storage and destruction of finished product controlled sample
o Validating sample records
Documentation department has the responsibility to keep all the
documents and registers up to date.
7. INSTRUMENTS DEVICES AND EQUIPMENTS
Hot air oven

14. Dissolution test apparatus
Vacuum oven
Bulk density apparatus

15. Muffle furnace
Centrifuge
Magnetic stirrer

16. Ultrasonic bath
U.v cabinet
Bursting test apparatus

17. U.v visible spectrophotometer (double beam)
FT-IR spectrophotometer (Fourier transform infrared)
Karl fisher titrator

18. HPLC system
Polari meter
Digital PH meter
And many more….

19. 8. PRODUCTION DEPARTMENT
Production department is the place where drug are manufactured, labeled and
packed. The production department is aseptic area with the help of HEPA and
other air purifiers where pharmaceutical product is prepared.
The different dosage forms are produced in plant, are as follows: -
1. Dusting powder (candid dusting powder)
2. Cough syrup (ascoril cough syrup)
3. Medicated shampoo (Scalpe plus)
 DUSTING POWDER:-
Candid dusting powder is used to treat skin and vaginal infections caused
by fungus, ringworm and yeast. The powder form of this medicine inhibits
fungi and yeast from generating ergosterol, which is a component of the
microbial cell membrane. By creating holes in the microbial cells, this
medicine degenerates the building block of the fungi or the yeast; thereby
destroying them. It helps to cure skin infections such as athlete’s foot, jock
itch, and ringworm. It helps provide relief from conditions such as skin
irritation, redness, itching, cracking of the skin and discomfort caused by
such infections.
First of all clotrimazole I.P 1% w/w is weighed and then talc are
added and then it is passed through a particular sieve size for a uniform
content then the filling process starts and then the sealing of container
starts and then the process for quality control starts.
 COUGH SYRUP:-
Ascoril cough syrup is an antihistamine which works by blocking the action
of histamine in the body. It is used for relieving symptoms of sinus
pressure, sinus congestion, and runny nose, itching of the throat and nose,
watery eyes, and sneezing due to upper respiratory infections, hay fever
and allergies.
First of all guaifenesin drug is used and then terbutaline is mixed
with it then bromhexine is mixed in it and this operation is done in a highly
packed containers and a big mixer is used for mixing and for uniform size is

20. made and then it is added in containers and further to labeling and then
packing of the dosage form is done and further to storage department.
 MEDICATED SHAMPOO:-
Scalpe shampoo helps in treating seborrhoeic dermatitis of the scalp,
dandruff. It also helps in curing fungal infections, yeast infection of the skin,
flaking and itching. The medication prevents the growth of various types of
fungi by disrupting the production of the membranes that surround the
fungal cells. It contains ketoconazole topical and zinc pyrithione topical as
active ingredients. Scalpe skin shampoo works by interfering and
weakening with the formation of the fungal cell membrane; treating the
seborrhoeic dermatitis of the scalp. This shampoo interacts with alfentanil,
alprazolam b, aprepitant, artesunate and others.
The shampoo is prepared in a sterile area first ketoconazole
which is also a main drug is used and then zinc pyrithione are mixed and
then is packed in a plastic container and labeled and then further to store
department.
9. QUALITY CONTROL DEPARTMENT
Quality control department is the most important department in
standardization of the product. Quality control department is responsible
for sampling and analysis as per approved specifications. Release/reject
authority for all raw materials, packing materials, intermediate products
and finished products lies with the quality control only. The laboratory has
been designed and equipped with the facilities for chemical, instrumental,
microbiological and stability testing. Instrumental room is temperature
controlled.
FUNCTIONS OF QUALITY CONTROL DEPARTMENT:-
 To establish and revise quality control procedures of specification
 To prepare detailed and written instruction to carry out inspection, test and
analysis
 To establish written sampling and sampling procedures
 To evaluate the stability of finished product and raw materials

21.  To validate the method of analysis
 To maintain the analytical record of the test of all sample
 To participate in the self inspection programme
 To prepare secondary reference standards for testing of products and to
store under proper condition
EQUIPMENTS IN QUALITY CONTROL DEPARTMENT
 U.V spectrophotometer
 Digital pH meter
 Melting point apparatus
 Hot air oven
 Centrifuge apparatus
 Microscope set
 Tablet hardness test apparatus
 Single pan balance (electrical)
 Vaccum oven
 Ultrasonic apparatus
 Autoclave lab model
 Magnetic stirrer with hot plate
 Sieve analysis set
 Refrigerator 350 volt
 Bulk density apparatus
 Tablet dissolution test apparatus
 HPLC
 TLC
 Water bath with thermostat control
 Laminar air flow bench
10. QUALITY ASSURANCE DEPARTMENT
Quality assurance department is dedicated for maintaining total quality of system
and products as per WHO and CGMP requirements to ensure that pharmaceutical
product are of the quality required for their intended use.
FUNCTIONS/RESPONSIBILITIES OF QUALITY ASSURANCE DEPARTMENT:-

22. o Ensure compliance of national and international regulatory WHO and
CGMP requirements
o Approve and verify implementation of defined systems, standards and
procedure
o Ensure availability of approved procedures and specifications for reference
o Review batch manufacturing and testing records, before giving product
release
o Take action on product recalls and investigate the reasons
o Handling of regulatory inspection at the site
o Investigate complaints, deviation, quality incidents and non conformances
o Review product stability reports
o Annual product quality review
o Ensure implementations of pest and rodent control, as per defined
schedules
o To review and approval of master validation program, including
equipments, processes, facilities analytical methods, etc
o Review batch manufacturing records, verify reconciliation of batch inputs,
batch yields and finally release the product
o Internal audit
o Support validation activity
o Ensure WHO-GMP/CGLP training to the staff
o Ensure implementation of amendments in specification and procedures as
per current pharmacopoeia standards
o Document control
o Vendor development and approval
o Developing quality policy and standards

23. 11. PRODUCTS (from Nashik plant)
 Ascoril cough syrup (expectorant)
 Candid dusting powder
 Scalpe plus (medicated anti dandruff shampoo)

24. 12. PERSONNEL AND ADMINISTRATION
1. MR. YOGESH SONAR
PLANT HEAD, HUMAN RESOURCES AND ADMINISTRATION
2. MR. SANJAY JOSHI
PRODUCTION MANAGER
3. MR. RAJENDRA TAMBE
ASST. PRODUCTION MANAGER
4. MR. BHAGWAN GADGE
Q.A MANAGER
5. MR. GIRISH KULKARNI
Q.C MANAGER
6. MR. DATTATRAYA KALE
WAREHOUSE MANAGER
13. CONCLUSION
By my industrial training I can conclude that GLENMARK PHARMACEUTICALS.LTD
is a GMP certified industry. It is producing good quality pharmaceutical products
like dusting powder, cough syrup, medicated shampoo and many more and also
has a good and well developed engineering unit. The employees and employers in
the industry are all well experienced.
In my case training played an important role for me to understand the
different modern techniques are it gave me an idea about the large scale
development of medicines and active pharmaceutical ingredient and I also got
some innovative concepts about newer technologies, and Glenmark has a very
well developed proper management system, developed research and
development department, a good quality control as well as a good quality
assurance department and this all is because of the industries hard work and
dedicated employees,
I wish them for their bright future.