Cohance Lifesciences Limited (formerly Suven Pharmaceuticals Ltd) has received a Warning Letter from the US Food and Drug Administration (US FDA) following an inspection conducted at its Finished Dosage Formulations (FDF Unit-I) facility in Nacharam, Hyderabad. The company is addressing the observations with corrective and preventive actions as per regulatory guidelines.
Cohance Lifesciences Limited announced on February 4, 2026, that it has received a Warning Letter from the United States Food and Drug Administration (US FDA) concerning its Finished Dosage Formulations (FDF Unit-I) facility in Nacharam, Hyderabad. The letter follows an inspection held between August 4 and August 12, 2025, during which six observations were noted in Form FDA-483.
The US FDA classified the facility as “Official Action Indicated (OAI)” and requested a structured response within the stipulated period. Cohance Lifesciences has reaffirmed its commitment to maintaining quality and regulatory excellence, assuring that it is engaging proactively with regulatory authorities to resolve all issues comprehensively.
Key Developments
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The facility’s US sales accounted for less than 2% of consolidated FY25 revenue, with an EBITDA contribution below 1%.
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The company has initiated corrective and preventive measures aligned with FDA expectations.
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No penalty, sanction, or restriction has been imposed currently.
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Cohance Lifesciences aims to ensure continued global supply of high-quality pharmaceutical products.
Sources: Company filing on BSE, NSE; United States Food and Drug Administration (US FDA).