Aurobindo Pharmaceutical Limited

Warning LetterClosed

Mr. Narayanan Govindarajan Managing Director Aurobindo Pharmaceutical Limited Floor No.’s 22, 23 & 24 Galaxy Plot No-1, Survey No: 83/1, Hyderabad Knowledge City Raidurg Panmaktha, Ranga Reddy District Hyderabad 500081 Telangana IndiaFEI 3004021253Issued Jan 12, 2022Center for Drug Evaluation and Research | CDER

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Letter Details

Firm: Aurobindo Pharmaceutical Limited
Location: Mr. Narayanan Govindarajan Managing Director Aurobindo Pharmaceutical Limited Floor No.’s 22, 23 & 24 Galaxy Plot No-1, Survey No: 83/1, Hyderabad Knowledge City Raidurg Panmaktha, Ranga Reddy District Hyderabad 500081 Telangana India
FEI Number: 3004021253
Country: India
Issue Date: January 12, 2022
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Closed
Closeout Letter: November 17, 2025

Summary

Aurobindo Pharmaceutical Limited's drug manufacturing facility in India was cited for significant deviations from current good manufacturing practice (CGMP) standards for active pharmaceutical ingredients (APIs), rendering their products adulterated. During an August 2021 inspection, the FDA identified a critical failure to adequately evaluate how increasing acceptable limits for impurities in an API starting material would affect the quality of the final API—the company raised specification limits based on incomplete lab-scale studies that did not assess all potential impurities that could be generated. Rather than conducting a comprehensive impact analysis, Aurobindo relied on insufficient data to justify the specification changes, creating potential quality and safety risks in their drug products.

Aurobindo Pharmaceutical Limited FDA Warning Letter, January 12, 2022