Cohance Lifesciences' FDF Unit-I Receives USFDA Inspection Classification of 'Official Action Indicated' with Minimal Revenue Impact

Cohance Lifesciences Ltd. has announced that their Finished Dosage Formulations Manufacturing Facility (FDF Unit-I) located in Nacharam, Hyderabad, has received an USFDA inspection classification of 'Official Action Indicated' (OAI) after a completed inspection with 6 observations. The company is proactively engaging with the USFDA and has initiated a comprehensive remediation program to align the facility with global standards. The FDF Unit-I at Nacharam continues to operate normally, with minimal impact on the company's ongoing operations and supplies. In FY2025, the US revenue from this formulation unit was less than 2% of the company's consolidated revenues and had a related EBITDA contribution below 1%. Cohance Lifesciences remains committed to maintaining high standards of quality and regulatory compliance in all their operations.