U.S. FDA issues warning letter to Cohance’s FDF facility in Hyderabad

U.S. Food and Drug Administration has issued a warning letter to Cohance Lifesciences’ (formerly Suven Pharmaceuticals) finished dosage formulations manufacturing facility (FDF Unit-I) in Hyderabad.

The warning letter is in continuation of the official action indicated (OAI) classification, of the facility, by the U.S. FDA earlier. The regulator had conducted a Good Manufacturing Practices (GMP) inspection in August and on completion issued a Form 483 with six observations. Cohance shares closed 3.77% lower at ₹366.75 each on the BSE on Wednesday.

U.S revenues from the facility contributed less than 2% of consolidated revenues, with related EBITDA contribution below 1%, in FY2025, indicating no material impact. The company had reported consolidated revenue from operations of ₹1,197.58 crore last fiscal. “We are committed to addressing the concerns raised by the U.S. FDA and will work with the U.S. FDA to resolve these issues at the earliest,” the company said in a filing.