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

U.S. Food and Drug Administration has issued a informing missive to Cohance Lifesciences’ (formerly Suven Pharmaceuticals) finished dosage formulations manufacturing installation (FDF Unit-I) successful Hyderabad.

The informing missive is successful continuation of the authoritative enactment indicated (OAI) classification, of the facility, by the U.S. FDA earlier. The regulator had conducted a Good Manufacturing Practices (GMP) inspection successful August and connected completion issued a Form 483 with six observations. Cohance shares closed 3.77% little astatine ₹366.75 each connected the BSE connected Wednesday.

U.S revenues from the installation contributed little than 2% of consolidated revenues, with related EBITDA publication beneath 1%, successful FY2025, indicating nary worldly impact. The institution had reported consolidated gross from operations of ₹1,197.58 crore past fiscal. “We are committed to addressing the concerns raised by the U.S. FDA and volition enactment with the U.S. FDA to resoluteness these issues astatine the earliest,” the institution said successful a filing.