Dr. Reddy's gets 5 observations from USFDA for Srikakulam formulations facility

15 Dec 2025 Evaluate

Dr. Reddy's Laboratories has received Form 483 with 5 observations from the United States Food and Drug Administration (USFDA) for its formulations facility (FTO-SEZ PU01) in Srikakulam, Andhra Pradesh. The USFDA conducted a GMP and a Pre-Approval Inspection (PAI) of the said facility from December 4 to December 12, 2025.

Dr. Reddy's Laboratories is a multinational pharmaceutical company based in Hyderabad, Telangana in India. It manufactures and markets a wide range of pharmaceuticals in India and overseas.

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