Sun Pharma's Halol facility receives FDA "official action indicated" classification

Sun Pharmaceutical Industries Limited reported that its Halol facility has been classified as "Official Action Indicated" (OAI) by the U.S. Food and Drug Administration (FDA). This classification, following an inspection from June 2 to June 13, 2025, indicates the FDA considers the facility not fully compliant with certain current good manufacturing practices (CGMP).

Consequently, the Halol facility remains under an Import Alert, leading to the refusal of shipments to the US. This restriction will continue, with certain exemptions for drug shortages, until the facility achieves full compliance with FDA and CGMP standards.

Sun Pharma reiterated its commitment to collaborating with the FDA and upholding CGMP standards across all its facilities to deliver high-quality medicines globally. The announcement was made by Anoop Anjanikumar Deshpande, company secretary and compliance officer.