Sun Pharma Gets OAI Classification from USFDA for Baska Facility

Sun Pharma on Thursday said the US health regulator has classified its Baska facility in Gujarat under Official Action Indicated (OAI) category following an inspection.

The US Food and Drug Administration (USFDA) conducted the inspection at the plant from September 8 to September 19, 2025.

The USFDA has subsequently determined that the inspection classification status of this facility is Official Action Indicated (OAI), the Mumbai-based drug major said in a regulatory filing.

As per the USFDA, OAI implies that the regulator may withhold approval of any pending product applications or supplements filed from such facility till the outstanding observations related to non-compliance of manufacturing norms laid down by it.

“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 drug maker said.

Shares of the company were trading 2.38% down at ₹1,752.40 apiece on BSE.