Cohance Lifesciences Limited has received a Warning Letter from the U.S. Food and Drug Administration (USFDA) concerning its Finished Dosage Formulations (FDF) manufacturing facility located at Nacharam, Hyderabad. This follows an inspection conducted by the USFDA from August 4, 2025, to August 12, 2025, during which the facility was classified as Official Action Indicated (OAI). The company stated its commitment to addressing the concerns raised by the USFDA and working towards resolving these issues at the earliest. Cohance Lifesciences also highlighted that in FY2025, US revenues from this specific facility contributed less than 2% of consolidated revenues, with a related EBITDA contribution below 1%, indicating no material impact on overall financials. The company reiterated its commitment to maintaining the highest standards of quality and regulatory compliance across all its operations, ensuring the supply of high-quality pharmaceutical products for global markets. This disclosure is in continuation of previous communications dated August 13, 2025, September 18, 2025, and October 26, 2025.
