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.

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 Agency

Status

Last Audited/Licensed

United States Food and Drug Administration

Compliant

2019

Agence Nationale De Securite of France

Compliant

2017

Pharmacy & Poison Board of Kenya

Compliant

2015

Therapeutic Goods Administration of Australia

Compliant

2013

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