Cohance addresses USFDA observations, affirms compliance and minimal financial impact

Cohance Lifesciences Limited, formerly Suven Pharmaceuticals Limited, on September 18, 2025, issued a clarification regarding recent electronic media reports concerning a USFDA inspection. The company confirmed that its Finished Dosage Formulations Manufacturing Facility (FDF Unit-I) in Nacharam, Hyderabad, received a Form 483 with six observations following an inspection concluded on August 13, 2025. Cohance has since submitted a comprehensive Corrective and Preventive Action (CAPA) plan to the USFDA and remains committed to quality and compliance.

The company highlighted that US revenues from this facility contributed less than 2% of consolidated revenues in FY2025, with related EBITDA contribution below 1%, indicating no material financial impact. Cohance reiterated its commitment to maintaining high standards of quality and regulatory compliance across all its manufacturing facilities.

In related news, Cohance announced its management would attend the JP Morgan conference in Mumbai on September 23, 2025, and a JP Morgan Roadshow in Hyderabad on September 24, 2025, for analyst and institutional investor meetings. The company stated that no unpublished price-sensitive information would be shared during these interactions.