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.
Wintac’s facility maintains a vigorous compliance record with many regulatory agencies, international and domestic:
United States Food and Drug Administration
Agence Nationale De Securite of France
Pharmacy & Poison Board of Kenya
Therapeutic Goods Administration of Australia