Sun Pharmaceutical Industries Ltd. informed exchanges that the US Food and Drug Administration (FDA) has classified its Halol facility as “Official Action Indicated (OAI)” following an inspection conducted between June 2 and June 13, 2025.
The OAI status means the FDA has determined that the site is not fully compliant with current good manufacturing practices (CGMP). Consequently, the facility remains under an Import Alert, leading to refusal of shipments from Halol into the US, except for certain exemptions granted due to drug shortages.
Sun Pharma reiterated that it remains committed to working with the FDA and ensuring compliance at all facilities while maintaining the highest quality standards for patients worldwide
