INDUSTRIAL TOUR REPORT PRAVASH

INDUSTRIAL

TOUR REPORT

SUBMITTED BY :- NAME :- PRAVASH PATEL ROLL No. :- 10121EN023 CLASS :- B.Pharm Part- IV DEPARTMENT OF PHARMACEUTICS IIT(BHU),VARANASI

TOUR REPORT

Acknowledgement

It is with utmost pleasure, I, Pravash Patel, express my gratitude with all those who have being helpful during

my industrial tour and helped me understand the fundamentals in a more practical and easy way.

I express my profound gratitude to Dr. B. Mishra head of department for organizing such an interesting industrial

tour. Then I would also like to thank Dr. R.S.Srivastava sir who accompanied us to the tour and made all possible

arrangements for smooth flow of the tour.

Next I would also like to thank the coordinator guides of various industries we visited to lead us in the working

areas and give a guided tour of the same. Also the various officers of Dr. Reddys Lab, Disto Pharmaceuticals

Hyderabad, IPC Chennai , Karnataka Antibiotics Limited Bangalore who out of their busy schedule , spared some

time out to discuss various sophisticated and valuable information related to the smooth functioning of these

million and billion rupees worth companies with us.

Lastly I would like to thank all my colleagues, in whose wonderful company I was able to relish the tour even

more. My special thanks to Miss Jagdeep Kaur Sandhu for coordinating with me to carry out the tour very

successfully.

Thanks and Regards

TOUR REPORT

Itinerary 1. Leaving from varanasi 02/12/2012

2. Visit to Dr. Reddys, Hyderabad 05/12/2012

3. Visit to Disto Pharmaceuticals Limited, Hyderabad

06/12/2012

4. Visit to IPC, Chennai 09/12/2012

5. Visit to Karnataka Antibiotics Limited 13/12/2012

6. Returning back to varanasi 15/12/2012

TOUR REPORT

Dr. Reddy's Laboratories Ltd

Dr. Reddy's Laboratories Ltd, is a pharmaceutical company based in Hyderabad, Andhra Pradesh, India. The company was

founded by Anji Reddy, who had previously worked in the publicly owned Indian Drugs and Pharmaceuticals Limited, of

Hyderabad, India. Dr. Reddy's manufactures and markets a wide range of pharmaceuticals in India and overseas. The

company has over 190 medications, 60 active pharmaceutical ingredients (APIs) for drug manufacture, diagnostic kits,

critical care, and biotechnology products.

Dr. Reddy's began as a supplier to Indian drug manufacturers, but it soon started exporting to other less-regulated markets

that had the advantage of not having to spend time and money on a manufacturing plant that would gain approval from

a drug licensing body such as the U.S. Food and Drug Administration (FDA). By the early 1990s, the expanded scale and

profitability from these unregulated markets enabled the company to begin focusing on getting approval from drug

regulators for their formulations and bulk drug manufacturing plants in more-developed economies. This allowed their

movement into regulated markets such as the US and Europe.

Dr. Reddy’s began as an API manufacturer in 1984, producing high-quality APIs to first the Indian, and later, the

international markets. In 1987, we started our formulations operations and, after becoming a force to reckon with in the

Indian formulations market, went international in 1991.

TOUR REPORT

Dr. Reddy’s - India today is more than a 200 million dollar venture with presence in almost all major therapeutic areas.

Our finished dosage business in India started in 1986 with launch of Norilet (norfloxacin). Our market penetration through

nearly 3000 sales force who connect to more than 3,00,000 doctors on a regular basis has yielded us reaching all corners

of the country and providing affordable and innovative medicines in all major therapeutic areas like gastro-intestinal,

oncology, pain management, cardiovascular, dermatology, diabetes, etc. Eight of our brands feature in the top-300 brands

in India that include drugs like Stamlo, Reditux, Omez and Ketorol.

Therapeutic Areas

» Gastro-Intestinal » Cardiovascular » Pain Management » Anti-Infective » Dermatology » Diabetology » Nutraceuticals » Oncology » Respiratory » Stomatologicals » Urology » Gynaecology » Haematology » Paediatric » Central Nervous System

TOUR REPORT

Disto Pharmaceuticals Pvt. Ltd (DPPL)

Disto Pharmaceuticals Pvt. Ltd (DPPL)was established in the year 2002 and is one of the leading pre-Formulation pharmaceutical manufacturing companies located in thePharmaceutical hub , Hyderabad, India. Disto is one of the fastest growing organizations in the specialized field of drug loaded Sustained and Delayed release pellets formulations . Focus on meeting customers demands on quality and delivery schedules is the key to Disto's success . DPPL is one of the largest manufacturers and exporters of niche products and has attained market leadership. The company has a major presence in Middle Eastern, African & Latin American markets and is continuously striving to increase its geographical reach. Products offered:

Treatment of benign prostatic hyperplasia

Antidepressant

Antinflammatory

Decongestant

Antihypertensive

Antiasthmatic

Mucolytic

Lipid lowering agent

Antispasmodic

Treatment of ulcerative colitis

Obesity management

Antifungal

Antiallergic

Antiulcerant

Antidiabetics

Antibacterial

TOUR REPORT

Services offered:

Extensive formulation development assistance including prototype construction, method development and validation

and process optimization

Bio-batches/Clinical Samples from a cGMP facility

Regulatory & Documantation support to the products offered

Customized drug-release profiles

TOUR REPORT

Research and Development

Improvement and optimization are continuously monitored at Disto.

Focused development work on solubility enhancement and taste masking.

Capabilities available for development of patent non-infringing products and processes

Under Development

Pellets

Carvedilol Phosphate Extended Release Pellets 20%

Tolterodine Tartrate Extended Release Pellets 2%

Blended Pellets of Ferous Glycine Sulfate & Folic Acid

Granules

Ibrufen taste masked granules

Aspirin taste masked granules

Sildenafil taste masked granules

Ciprofloxacin taste masked granules for suspension 20%

TOUR REPORT

KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD. (KAPL) BANGALORE

Karnataka Antibiotics & Pharmaceuticals Ltd., (KAPL) Bangalore is a Government Enterprise. From a modest beginning in 1984, KAPL has grown from strength to strength in the areas of manufacturing and marketing of various life saving and essential drugs. With an ISO accredition from KPMG, Netherlands, KAPL is recognised for its total commitment to quality and services in domestic and international markets. On profit from inception, KAPL facilities are approved by many international clients

MANUFACTURING FACILITIES MAJOR PRODUCT CATEGORY KAPL offers a comprehensive range of life saving dosage forms: (Pharma and Veterinary)

PARENTERAL ANTIBIOTICS.

NON–PARENTERAL ANTIBIOTICS & OTHERS.

PARENTERAL PRODUCTION – KEY FACILITIES

DRY POWDER PARENTERAL PLANT [ DPP – I ] A separate dedicated plant for ß-lactam [Penicillin] injectables like Benzyl Penicillin, Ampicillin Sodium, Benzathine Penicillin, Fortified Procaine Penicillin etc.

TOUR REPORT

DRY POWDER PARENTERAL BLOCK [ DPP – II ] For manufacturing Non ß-lactam & Cephalosporin injectables. SMALL VOLUME PARENTERAL [ SVP ] For manufacturing liquid injectables of 2 ml vials to 100 ml vials & ampoules of 1 ml to 10 ml. ß-LACTAM INJECTABLE FACILITY – Salient Features:

o High tech, automated aseptic continuous production line capable of handling multi products, multi dosages to the highest accuracy and with least human intervention.

o Vial washing, sterilization and cooling system: Gilowy, Germany – Capacity, 240 vials per minute.

o Line capacity – 80,000 vials per shift of 8 hours.

o Class 100 up to sealing.

o Separate classified area 10,000 for sealing process under class 100 LAF.

o Mezzanine at the top with all the services of utilities with separate AHUs.

o Loop system for de-mineralized water and water for injection.

o Automatic filling and stoppering operation without manual handling.

o Automatic Sticker Labeling Machine – 120 vials / minute.

NON ß-LACTAM INJECTABLES MANUFACTURING FACILITY: Filling and stoppering automatic equipment from “Perry” USA. Filling, stoppering under class 100. Continuous line, starting from filling to packing. Capacity 50,000 vials per shift of 8 hours. SMALL VOLUME PARENTERALS: 50,000 vials (2 ml) per two shifts / day. 50,000 ampoules (2 ml to 3 ml) per two shifts / day. Classified area 100 for filling and stoppering in sterile area. Mezzanine at the top with services and AHU’s.

TOUR REPORT

CGMP design / model for WFI plant with 500 litre / hour capacity. NON-PARENTERAL KEY FACILITY: TABLETS: Facility for Film coating, Enteric coating, Blister packing & Aluminium strip packing. Machines / equipments for manufacturing tablets from 6 mm to 13 mm, Capacity 10 lakhs per shift. Machines / equipments for large tablets / bolus upto 6 gram weight. CAPSULES: Separate area for ß-lactam & Non-ß-lactam capsules dosage forms. 10 lakh capsules per two shifts, size ‘2’ to size ‘0’. LIQUID ORALS & DRY SYRUP, SACHETS & POWDERS: Facility for liquid syrup & suspension from 30 ml bottle to 5 litre container. Facility for dry syrup bottles 30 to 100 ml. Facility for powders in sachets, containers, 20 gm to 5 kg. QUALITY ASSURANCE FACILITY: Separate area for Chemical, Pharmacological, Microbiological, instrumental analysis. Separate classified 100 area with HVAC for sterility testing. Separate instrument room with sophisticated latest analytical instruments like HPLC, IR, GC etc. Qualified & trained analyst & Microbiologist. RM & PM STORE: Segregation of RM & PM as per CGMP requirements. Receipt / Issues / Approval / Rejection through Integrated Information System. Cool room for storing antibiotics, capsules etc. Classified area for dispensing of RM for oral dosage form. KEY QUALITY ASSURANCE SYSTEMS FOLLOWED

TOUR REPORT

o In house testing as per international specifications. o Area / filters validations. o Aseptic filling process validation by broth fill trials. Protocol includes simulation

trials for intrusions / interruptions. o Water system validation [ DM & WFI ]. o IPQC. o Self inspection. o Training – GMP. o Medical Health Monitoring.

o Stability studies as per ICH guidelines for selected products. o Analytical method validation as per ICH guidelines. o Hold time for sterilized components – validation. o Equipment cleaning validation – product change over etc. o Routine biological control [ Water, clean rooms and other manufacturing areas]. o Effective handling of Market complaints.