Mumbai: Sun Pharma has announced that the company has received Official Action Indicated (OAI) status from the U.S. Food and Drug Administration (USFDA) for Baska facility.
The USFDA conducted an inspection at the facility from 8 September 2025 to 19 September 2025.
OAI means regulatory and/or administrative actions are recommended.
“We continue to manufacture and supply approved products from the facility to the US market. We will work with the regulator to achieve fully compliant status,” the company stated in a BSE filing.
Sun Pharma is a specialty generics company with a presence in specialty, generics and consumer healthcare products. Sun Pharma’s global specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for over 18% of company sales. Its manufacturing facilities are spread across six continents.
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