USFDA classifies Hyderabad FDF Unit-I of Cohance Lifesciences as Official Action Indicated
Company initiates remediation measures; confirms limited revenue contribution from the facility and no material impact on operations
In continuation of its earlier communication dated August 13, 2025, regarding the completion of inspection by the US Food and Drug Administration (USFDA) at its Finished Dosage Formulations Manufacturing Facility (FDF Unit-I) in Nacharam, Hyderabad, Cohance Lifesciences (formerly Suven Pharmaceuticals) has informed that the facility has now been classified as “Official Action Indicated (OAI)” by the USFDA.
The company stated that during the inspection, it had received Form 483 with six observations. Following this, it has now received the report from the USFDA confirming the OAI classification. The company further informed that it is engaging proactively with the USFDA and has initiated a comprehensive remediation programme to align the facility fully with global standards.
According to the company, the FDF Unit-I facility at Nacharam continues to operate normally. It also reiterated, as clarified earlier on September 18, 2025, that in FY2025, the US revenue from this unit contributed less than 2 per cent of the company’s consolidated revenues, with the related EBITDA contribution below 1 per cent. Hence, the company does not expect any material impact on its ongoing operations or supplies.
The company stated, “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.”