USFDA Issues Warning Letter to Cohance Lifesciences' Hyderabad FDF Unit

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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