Cohance Lifesciences has announced that the U.S. Food and Drug Administration (USFDA) has classified its Finished Dosage Formulations (FDF) Manufacturing Facility (Unit-I) in Nacharam, Hyderabad as “Official Action Indicated” (OAI). The update follows the company’s earlier intimation dated August 13, 2025, when the facility had received a Form 483 with six observations after a routine inspection.
According to the company’s statement, Cohance Lifesciences has already initiated a comprehensive remediation program to address the observations and ensure full alignment with global regulatory standards. The company added that operations at the FDF Unit-I facility continue to run normally despite the classification.
Cohance Lifesciences further clarified that the impact of this development on its overall business remains minimal. The Hyderabad formulation unit contributed less than 2% to the company’s consolidated revenues in FY2025, with an EBITDA contribution of below 1%. Therefore, the OAI classification is not expected to have any material effect on its ongoing operations or product supplies.