Mumbai: The US Food and Drug Administration (US FDA) has classified Sun Pharmaceutical Industries’ Baska manufacturing facility in Gujarat as Official Action Indicated (OAI) following an inspection conducted in September, the company said in a regulatory filing on Thursday.
The inspection at the Baska facility was carried out between September 8 and September 19, 2025, after which the US regulator assigned the OAI status, indicating that regulatory action may be required to address the observations made during the inspection.
Sun Pharma, however, said it continues to manufacture and supply approved products from the Baska unit to the US market, suggesting that the classification does not immediately disrupt supplies. The company added that it is engaging with the regulator and will work towards bringing the facility back to a fully compliant status.
An OAI classification is considered the most serious inspection outcome by the US FDA and typically follows unresolved compliance issues observed during inspections.
For Indian drugmakers, US FDA scrutiny is closely tracked by investors as the US remains a key export market for generic medicines.
Sun Pharma, India’s largest pharmaceutical company by market capitalisation, has faced periodic regulatory observations at some of its plants in the past and has undertaken remediation measures to resolve them.
The latest disclosure comes amid continued regulatory vigilance by the US FDA on overseas manufacturing facilities supplying to the American market.