Sun Pharma's Baska facility receives FDA official action indicated status

Sun Pharmaceutical Industries Limited reported that its Baska facility has received an Official Action Indicated (OAI) classification from the US FDA. This determination follows an inspection conducted between September 8, 2025, and September 19, 2025. An OAI classification indicates that the US FDA may withhold approval of new applications or supplements from the facility or may take other actions.

Despite the OAI classification, Sun Pharma stated that it continues to manufacture and supply approved products from the Baska facility to the US market. The company also affirmed its commitment to working with the regulator to achieve fully compliant status for the facility.

The announcement was made by Anoop Deshpande, company secretary and compliance officer, on December 18, 2025.