USFDA completes PAI at Dr. Reddy's biologics manufacturing facility in Hyderabad

15 Sep 2025 Evaluate

United States Food & Drug Administration (USFDA) has completed Pre-Approval Inspection (PAI) at Dr. Reddy's Laboratories’ biologics manufacturing facility in Bachupally, Hyderabad. The inspection was conducted from September 4, 2025 to September 12, 2025. The company has been issued a Form 483 with five observations, which the company will address within the stipulated timeline. 

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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