Sun Pharmaceutical Industries has confirmed that its Halol manufacturing facility in Gujarat, India, has been classified as “Official Action Indicated” (OAI) by the US Food and Drug Administration following a compliance inspection conducted in June 2025. The inspection resulted in eight observations where the plant failed to meet certain requirements under current Good Manufacturing Practices (CGMP).

As a consequence of the OAI status, the Halol plant is subjected to an import alert, meaning that exports to the United States are halted—save for specific medicines that are exempted due to drug shortages in the US market. Shipments will remain suspended until the facility fulfils FDA compliance standards.

Sun Pharma has stated its commitment to working closely with the FDA to resolve the identified issues and restore compliance. The company emphasised its dedication to maintaining CGMP standards across all its facilities to continue supplying high-quality medicines to patients globally.