Generic Pharmaceutical Manufacturer Somerset

Manufacturing & Compliance

Wintac, Limited

Wintac, Ltd. is an affiliate of Somerset Therapeutics that produces vials, ampoules, and ophthalmic products.  The company has been USFDA-compliant since 2013 and was most recently audited by the agency in April of 2017 for general GMPs and pre-approvals without any 483 comments.

The company was founded in 1987 and operates out of a 120,000 sq ft facility with a 70,000 sq ft of sterile operations area.  The company has also been audited by the Australian and French regulatory authorities.

Compliance Record

Wintac’s facility maintains a vigorous compliance record with many regulatory agencies, international and domestic:

Regulatory AgencyStatusLast Audited/Licensed
United States Food and Drug AdministrationCompliant2017
Pharmacy & Poison Board of KenyaCompliant2015
Agence Nationale De Securite of FranceCompliant2014
Therapeutic Goods Administration of AustraliaCompliant2013
Joint Director General of Foreign Trade of IndiaCompliant2017
Narcotics Control Bureau of IndiaCompliant2017
Central Drugs Standards Control Organization of IndiaCompliant2017
Drug Controller General of IndiaCompliant2017
Department of Factory Boilers and Industrial Safety and Health of IndiaCompliant2015
Karnataka State Pollution Control Board of IndiaCompliant2016
Petroleum and Explosives Safety Organization of IndiaCompliant2017
Office of Assistant Labor Commissioner of IndiaCompliant2004
Office of Superintendent of Central Excise of IndiaCompliant2001

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