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Mumbai: Cohance Lifesciences has announced that the Company has received report from the United States Food and Drug Administration (USFDA), determining the inspection classification of Finished Dosage Formulations Manufacturing Facility (FDF Unit-I) located in Nacharam, Hyderabad as “Official Action Indicated (OAI)”. The Company is engaging proactively with the USFDA and has initiated a comprehensive remediation program and align the facility fully with global standards. The FDF Unit -1 facility at Nacharam continues to run its operations normally. Further, as intimated and clarified by Cohance on September 18, 2025, it reiterated that in FY2025, the US revenue from this formulation unit located at Nacharam contributed less than 2% of the Company’s consolidated revenues and with related EBITDA contribution below 1%. Therefore, it is not expected to have any material impact on the Company’s ongoing operations or supplies. "We remain committed to maintaining the highest standards of quality and regulatory compliance in all our operations and will continue to ensure the manufacture and supply of high-quality pharmaceutical products for global markets," the company stated in a BSE filing.The Good Manufacturing Practices (GMP) inspection was conducted from August 4, 2025 to August 12, 2025 excluding the weekend of August 9 and 10, 2025. Intially, in August, the Company received a Form 483 from the USFDA with 06 observations.Read also: Cohance Lifesciences announces USD 10 mn investment in cGMP Bioconjugation Suite at NJ BioCohance Lifesciences is a technology-driven CDMO, providing integrated solutions in custom synthesis, process R&D, and manufacturing for global innovators. The company has over 100 active projects and a pipeline of late-stage molecules.
