Cohance Lifesciences announced that the US FDA conducted an inspection at the Company's Finished Dosage Formulations manufacturing facility (FDF Unit-I) located at Nacharam, Hyderabad, from 04 August 2025 to 12 August 2025. Following the inspection, a Form FDA-483 containing six observations was issued by the US FDA. Based on these observations, the USFDA classified the facility as “Official Action Indicated (OAI)” and subsequently issued a Warning Letter for the said facility.
The Company is required to respond to the Warning Letter within the stipulated timelines prescribed by the US FDA and continues to engage with the regulator thereafter.
The US revenues from this facility contributed less than 2% of consolidated revenues in FY25, with related EBITDA contribution below 1%.