Cohance Lifesciences Limited

Warning LetterOpen

Dr. Vetukuri Venkata Naga Kali Vara Prasada Raju Managing Director & Chief Executive Officer Cohance Lifesciences Limited 202, 2nd Floor, A-wing, Galaxy by Aurobindo Realty, Sy. No. 83/1 Hyderabad Knowledge City, TSIIC, Raidurg, Panmaktha, Opp. IKEA Hyderabad 500081 Telangana IndiaFEI 3008768274Issued Jan 30, 2026Center for Drug Evaluation and Research (CDER)

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Letter Details

Firm: Cohance Lifesciences Limited
Location: Dr. Vetukuri Venkata Naga Kali Vara Prasada Raju Managing Director & Chief Executive Officer Cohance Lifesciences Limited 202, 2nd Floor, A-wing, Galaxy by Aurobindo Realty, Sy. No. 83/1 Hyderabad Knowledge City, TSIIC, Raidurg, Panmaktha, Opp. IKEA Hyderabad 500081 Telangana India
FEI Number: 3008768274
Country: India
Issue Date: January 30, 2026
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Cohance Lifesciences Limited, a drug manufacturer in Hyderabad, India, was cited for significant Current Good Manufacturing Practice (CGMP) violations in finished pharmaceutical products, rendering them adulterated. During an FDA inspection in August 2025, the company failed to conduct thorough investigations of batch failures and quality discrepancies, specifically lacking adequate root-cause analysis and corrective/preventive actions (CAPA), as demonstrated by inadequate investigation of customer complaints regarding tablet deterioration across multiple batches. The violations indicate that the company's manufacturing methods, facilities, and controls do not conform to federal regulations under 21 CFR parts 210 and 211.

Cohance Lifesciences Limited FDA Warning Letter, January 30, 2026