USFDA Issues Warning Letter to Cohance Lifesciences' Hyderabad FDF Unit
New Delhi: Cohance Lifesciences Limited has received a Warning Letter from the U.S. Food and Drug Administration (USFDA) for its Finished Dosage Formulations manufacturing facility (FDF Unit-I) located at Nacharam, Hyderabad, the company informed stock exchanges through a regulatory filing.
In its disclosure, the company stated that the Warning Letter is linked to the USFDA inspection conducted at the Nacharam facility from August 4, 2025, to August 12, 2025. The development is in continuation of the company’s earlier communications issued on August 13, 2025, September 18, 2025, and October 26, 2025, regarding the same inspection.
The company informed that the facility had previously been classified as Official Action Indicated (OAI) by the USFDA, and the Warning Letter has been issued as a continuation of that classification. Cohance Lifesciences said it remains committed to addressing the concerns raised by the USFDA and will work closely with the regulator to resolve the issues at the earliest.
Providing a financial impact assessment, the company highlighted that revenue from the United States generated through this facility contributed less than 2 percent to its consolidated revenues in FY2025. Additionally, the related EBITDA contribution from the facility remained below 1 percent, suggesting that the development is not expected to have any material financial impact on the company.
Cohance Lifesciences, formerly known as Suven Pharmaceuticals Limited, reiterated its commitment t maintaining the highest standards of quality and regulatory compliance across its operations and ensuring the manufacture and supply of high-quality pharmaceutical products for global markets.
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