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Sun Pharmaceutical Industries said the U.S. Food and Drug Administration (FDA) has classified its Halol manufacturing facility in Gujarat as official action indicated (OAI), indicating non-compliance with the regulator's manufacturing standards.

Sun Pharma's Gujarat facility gets official action indicated classification from US FDA

10-Sep-2025, 10:46

The classification follows an inspection conducted by the FDA from June 2 to June 13, 2025, during which eight observations related to current good manufacturing practices (CGMP) were issued.

Sun Pharma stated that the Halol site remains under an import alert, restricting shipments to the United States, except for certain products exempted due to drug shortages. The restrictions will continue until the facility meets the FDA's CGMP compliance requirements.

The company added that it remains committed to working closely with the FDA and addressing all observations to bring the facility into full compliance.

Sun Pharmaceutical Industries is the largest pharmaceutical company in India and is a leading generic company in the US as well as Global Emerging Markets.

The company's consolidated net profit tumbled 19.64% to Rs 2,278.63 crore despite of 10.07% increase in revenue from operations to Rs 13,786.07 crore in Q1 FY26 over Q1 FY25. The drop in profit was primarily due to a one-time exceptional charge of Rs 818 crore during the quarter.

Shares of Sun Pharmaceutical Industries shed 0.33% to Rs 1,589.80 on the BSE.