Cohance Lifesciences Responds to USFDA Warning Letter for Finished Dosage Formulations Manufacturing Facility

Cohance Lifesciences Ltd. (formerly Suven Pharmaceuticals Limited) has received a warning letter from the US Food and Drug Administration (USFDA) following an inspection of its Finished Dosage Formulations manufacturing facility (FDF Unit-I) in Nacharam, Hyderabad. The US FDA classified the facility as 'Official Action Indicated (OAI)' based on six observations. The Company is required to respond to the Warning Letter within the stipulated timelines and continues to engage with the regulator. The US revenues from this facility contributed less than 2% of consolidated revenues in FY25, with related EBITDA contribution below 1%. Cohance Lifesciences is taking corrective and preventive actions and preparing a comprehensive response to be submitted to the USFDA.