Cohance Lifesciences Limited (formerly Suven Pharmaceuticals Limited) has disclosed the receipt of a warning letter from the United States Food and Drug Administration (USFDA) concerning its Finished Dosage Formulations manufacturing facility (FDF Unit- I) at Nacharam, Hyderabad. The warning letter follows an inspection conducted by the USFDA from August 4, 2025, to August 12, 2025, which resulted in a Form FDA-483 with six observations. The facility has been classified as "Official Action Indicated (OAI)". The company stated that the US revenues from this facility contributed less than 2% of consolidated revenues in FY25, with related EBITDA contribution below 1%. Cohance Lifesciences is proactively engaging with the USFDA, undertaking corrective and preventive actions, and preparing a comprehensive response to be submitted within the stipulated timeframe. This disclosure is in furtherance of previous communications dated February 4, 2026, August 13, 2025, September 18, 2025, and October 26, 2025. The company emphasized its commitment to maintaining high standards of quality and regulatory compliance.
