USFDA completes GMP inspection at Dr. Reddy's API manufacturing facility in Bollaram

17 Jun 2023 Evaluate

United States Food & Drug Administration (USFDA) has completed a GMP inspection at Dr. Reddy's Laboratories’ API manufacturing facility in Bollaram, Hyderabad (CTO-3). The inspection was conducted from June 12, 2023 to June 16, 2023. The inspection closed with zero observations.

Additionally, the company has received the Establishment Inspection Report (EIR) from USFDA for its formulations manufacturing facility in Srikakulam (FTO SEZ PU2). The Agency has classified the inspection as Voluntary Action Indicated (VAI) and concluded that the inspection is ‘closed’ under 21 CFR 20.64(d)(3).  

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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