Sun Pharmaceutical Industries Ltd has informed the stock exchanges that the US Food and Drug Administration (US FDA) has classified its Baska manufacturing facility under Official Action Indicated (OAI) following a recent regulatory inspection.
The US FDA conducted an inspection at the Baska facility between September 8 and September 19, 2025. Based on the observations made during this visit, the regulator has subsequently assigned an OAI classification to the site. An OAI status indicates that the FDA has identified significant issues that may require regulatory action and expects corrective measures from the company.
Despite the inspection outcome, Sun Pharmaceutical clarified that the Baska facility continues to manufacture and supply approved products to the US market. The company stated that there has been no interruption to supplies from the site as of now.
Sun Pharma also emphasized that it is committed to working closely with the US FDA to address the observations raised during the inspection. The company plans to engage with the regulator and take necessary corrective and preventive actions to bring the facility back to a fully compliant status.
