Alkem laboratories limited (Daman)

A report submitted to RGPV, Bhopal (M.P.)

As a rerquirement for the award of the degree of
Bachelor of Pharmacy

Submitted by : Bundel Lodha (0155py151018)

RKDF SCHOOL OF PHARMACEUTICAL SCIENCE,BHOPAL
Nh-12,Hoshangabad Road jatkhedi, Bhopal
RKDF SCHOOL OF PHARMACEUTICAL SCIENCE,BHOPAL
Approved by –AICTE,PCI,New Delhi,RGPV Bhopal

CERTIFICATE
This is to certify that the student of Vl sem.
BUNDE LODHA have copleted his INDUSTRIAL TRAINING
REPORT in APRIL 2018 as per the ordinance of rajiv
Gandhi University of technology of Madhya Pradesh.

PRINCIPAL
 About Alkem Laboratories Ltd.
Alkem Laboratories Limited is an Indian pharmaceutical company based in Mumbai, Maharashtra, India.
Established in 1973 by
Mr. Samprada Singh, the company manufactures and sells branded generics, generic
drugs, active pharmaceutical ingredient(APIs) and neutraceuticals both in India and
internationally in 55 countries (mainly the US), including Australia, Europe, South East Asia, Latin
America, Africa and CIS.
The company has a wide ranging presence in the acute and chronic therapeutic segments
such as Anti-infectives, Gastro-intestinal, Pain Management, Vitamins, Minerals and
Nutrition, Central Nervous System, Anti-diabetic, Anti-osteoporosis, Anti-malarial,
Cardiovascular, Immunosuppressants and Nutraceutical segments.
As per its September 2015 figures, the company:
 Had a portfolio of 736 branded generic drugs
 Had 13 of its brands featured among the top 300 brands in India
 Was one of India’s top 10 pharmaceutical companies (in terms of domestic
sales) for the past 12 years
 Had 16 manufacturing facilities (all cGMP compliant):
 14 were in India
 2 were in US
 5 facilities were US FDA, TGA, UK MHRA approved
 Had 4 R&D facilities (2 in India and 2 in the US) employing 438 scientists
Ranked 5 in the Indian pharmaceutical market in terms of domestic sales in the fiscal year 2015, the
company enjoys a domestic market leadership in the following segments

 Ranked 1 in anti-infectives, with an 11.2% market share

 Ranked 3 in gastro-intestinals with a 5.6% market share
 Ranked 3 in pain/analgesics with a 5% market share
 Ranked among the top 10 in vitamins, minerals, nutrients and gynecology
 Alkem Laboratories Limited is listed on the National Stock Exchange of India (NSE) and the Bombay Stock Exchange (BSE).
• Alkem Laboratories Limited at-a-glance
• Sales Turnover USD 556 million
• Employees 13,132
• Field Force 5856
• Stockists 6576 Certifications US FDA
• Markets Served (countries) 55 TGA
• Manufacturing Facilities 16 UK MHRA
• R&D Centers 4 MCC
• ANDAs filed in the US 66
• Other Countries 983
• (Dossiers for each strength)
Source:
http://www.alkemlabs.com/, http://ww
w.alkemlabs.com/sites/default/files/files
/Annual-report-2015.pdf

•History of Alkem Laboratories Limited

Alkem Laboratories Limited was established in 1973 as a healthcare marketing firm by founders, Mr. Samprada
Singh and his brother, Mr. BN Singh. It started manufacturing in 1978, when it established its first plant at
Taloja, Mumbai
Since its incorporation in 1973, the company has grown significantl
• In the fiscal year 2015, it was the 5th largest pharmaceutical company in India in terms of domestic sales.
(Source: IMS Health
• ts domestic business grew at a CAGR of 14.2% from fiscal year 2011 to fiscal year 2015, which was faster than the Indian
pharmaceutical industry’s growth of CAGR of 12.2%. (Source: IMS SSA MAT March 2015)
• It was the 3rd fastest growing company among India’s top 10 domestic pharma companies by sales between the fiscal
year 2011 to 2015.
(Source: IMS SSA MAT March 2015
 Milestones
• 1973 – Starts operations as a healthcare marketing company
• 1978
– Establishes first plant at Taloja, Mumbai
– Alkem Laboratories Limited is incorporated
• 1992 – Establishes manufacturing facility in Mandura, Maharashtra (converted into an API
facility in 2005)
• 2003 – Sets up an in-house R&F facility for ANDA development at Taloja
• 2006 – Taxim becomes the first anti-infective drug in the Indian pharmaceutical industry to
cross INR 1,000 million in domestic sales
• 2007 – Files first ANDA in the US for the Amlodipine
• 2009 – Acquires Australian generic pharma company, Pharmacor Pty Ltd.,
• 2009 – Receives first ANDA approval in US for Amlodipine
• 2010 – Acquires US generic marketing company, Ascend Laboratories
• 2011 – Acquires Enzene, an Indian company engaged in the development of biosimilars
• 2012 – Acquires an API manufacturing facility in the US
• 2013 – Acquires another API manufacturing facility in the US
• 2014 – Clavam crosses INR 2,000 million in domestic sales in India
• 2014 – Acquires the “Clindac-A” brand in India from Galderma S.A.
• 2015 – Acquires a formulation manufacturing facility in the US
• BOARD OF DIRECTORS
• Founders: Mr. Samprada Singh, Mr. BN Singh
• Chairman Emeritus: Mr. Samprada Singh
• Executive Chairman: Mr. BN Singh
• Joint Managing Director: Mr. DK Singh
• Joint Managing Director: Mr. Sandeep Singh
• Directors: Mr. BP Singh, Mr. MK Singh, Mr. AK Purwar, Mr. RL Shenoy, Ms. Sudha
Ravi, Ms. Sangeeta Singh, Mr. AM Prasad, Mr. MC Shah
• Chief Executive Officer: Mr. Prabhat Agrawal
• Chief Financial Officer: Mr. Rajesh Dubey
• Sr. VP – Legal & Company Secretary: Mr. Manish Narang
Alkem Laboratories Limited Contact Details

HEAD OFFICE NVESTOR RELATIONS

Alkem Laboratories Limited
Devashish Building, Alkem House
Senapati Bapat Road, Lower Parel
Mumbai – 400 013
India
Email: contact@alkem.com
Phone: +91-22-3982 99 9
Mr. Gagan Borana
Alkem House, Senapati Bapat Marg
Lower Parel
Mumbai – 400013
India
Email: gagan.borana@alkem.com
Phone: +91-22-3982-9960
Fax: +91-22-2492-7190
Training Report | Alkem Pharmaceutical Limited
TABLE OF CONTENT

S/N CONTENT PAGE

1 Profile of Organisation
- About alkem
- Vision
- Mission
- Formulations

2 Production Section
- Production Section
- Granulation
- Compression
- Coating
- Packaging and Labelling
- Encapsulation

3 Capsule section
- Hard gelatin capluse

4 Quality Control & Quality Assurance Section

- Size and Shape
- Organoleptic Property
- Hardness and friability
- Weight Variation
5 Microbiology Section
- Microbiological Testing of Non-sterile produc
- Sterility Testing
- Validation
6 Engineering Section
- Electricity Unit
- Water Treatment System
- Water Softening Unit
- Chilling/Steam Unit
- Air Handling Unit (AHU)
- Effluent Treatment Plant (ETP)

7 Raw Material and Finished Goods Section

- Raw material
• Receiving
• Sampling
• Storing
• Dispensing
- Finished goods

8 Conclusion

9 Bibliography
 Training Report | Alkem Pharmaceutical Limited

VISION
“Our vision is to be aleading pharmaceutical company in India
and to become asignificant global player by providing high quality, and
affordable innovative solutions in medicine and treatment.”

MISSION
“We willdiscover, develop and successfully market pharmaceutical
products to prevent,diagnose, alleviate and cure diseases. We shall provide total
customer satisfaction and achieveleadership in chosen markets, products and
services across the globe, through excellence intechnology, based on world-class
research and development. We are responsible to the society.We shall be good
corporate citizens and will be driven by high ethical standards in our
practices.”
 Training Report | Alkem Pharmaceutical Limited

FORMULATIONS

Our extensive range of finished dosage Formulations covers

every aspect of human life. Our basket of formulations contain more
than 850 products in several forms belonging to 45therapeutic
segments and 12 specialities including cardiovascular, gastrointestinal
analgesics,haematinics, anti-infectives and antibiotics, respiratory
agents, antidiabetics, immunogicals andoncology. The manufacturing
expertise is available for almost all dosage forms including sterileas
well as non-sterile products. All of which are approved by all
prominent internationalregulatory bodies, including USFDA
 Training Report | Alkem Pharmaceutical Limited
PRODUCTION SECTION
GENERAL ISNTERCATIONS AND PRECAUSIONS
• Ensure area and equipment cleanliness before starting the manufacturing operations.
• Check and ensure that all manufacturing equipment and other required accessories are clean ready for use.
• wear gloves and nose mask during all manufacturing process.
• counter check the weight of all ingredients before using in the batch.
• Get line clearance from QC for manufacturing.
• Air handling unit (AHU) system should be kept ON throughout the manufacturing the process.
• Temperature should be kept between 25ºC ± 2ºC and relative humidity should be kept between 50±10%.
• Ensure that only QC approval purified water is being used for manufacturing purpose.
• Always transfer solution to the manufacturing vessels through 20 meshes.
•During the preparation of this product, no other product processing should be done in the same area.
• Whenever sifting through SS mesh is involve; check the mesh integrity before and after use.
• All critical aspects during manufacturing like temperature, duration of mixing ,weight, etc. must be checked and
recorded by the supervisor.
• Supervisor to ensure completion of al in-process record during various stages of manufacturing operation till
completion of the batch.
• release from QA should be taken from all in-process tests mentioned in batch manufacturing record .

• No over writing is allowed in batch manufacturing record. If initial data is wrong entered, cancel the data by
single stroke arrow and put initials. Record reasons for change as footnote on the same page.
• All the details whatever is necessary should be recorded in batch manufacturing record (BMR).
•Send a test request from to QC after manufacturing is completed.
• Check all polyethylene bags before and after material loading for black particles and sealing.
• Check calibration of respective equipment/machine before use.