Cohance Lifesciences Receives USFDA Warning Letter for Hyderabad Facility
Cohance Lifesciences received a USFDA warning letter for its Hyderabad FDF Unit-I facility after an inspection from August 4-12, 2025. The facility was classified as OAI. US revenues from this unit were less than 2% of FY25 consolidated revenues, with EBITDA contribution below 1%. The company is taking corrective actions.
While the direct financial impact appears limited (less than 2% of revenue), a USFDA warning letter can lead to increased scrutiny, potential supply chain disruptions, and reputational damage, necessitating corrective actions and potentially impacting future growth.
The company has received a warning letter from the USFDA, which is a significant regulatory action that can impact operations and market access.
Cohance Lifesciences Limited (formerly Suven Pharmaceuticals Limited) has disclosed the receipt of a warning letter from the United States Food and Drug Administration (USFDA) concerning its Finished Dosage Formulations manufacturing facility (FDF Unit- I) at Nacharam, Hyderabad.
The warning letter follows an inspection conducted by the USFDA from August 4, 2025, to August 12, 2025, which resulted in a Form FDA-483 with six observations. The facility has been classified as "Official Action Indicated (OAI)".
The company stated that the US revenues from this facility contributed less than 2% of consolidated revenues in FY25, with related EBITDA contribution below 1%. Cohance Lifesciences is proactively engaging with the USFDA, undertaking corrective and preventive actions, and preparing a comprehensive response to be submitted within the stipulated timeframe.
This disclosure is in furtherance of previous communications dated February 4, 2026, August 13, 2025, September 18, 2025, and October 26, 2025. The company emphasized its commitment to maintaining high standards of quality and regulatory compliance.
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Cohance Lifesciences Limited filed this with the NSE as a statutory disclosure, categorised under other regulatory filings. It is a primary document, not a recommendation, and the desk marks it medium impact: worth reading, rarely worth acting on by itself.
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See the model portfoliosA plain-language summary of a public exchange filing by Cohance Lifesciences Limited. Read the original for the full detail.