Dr Reddy’s clears USFDA inspection for two plants

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Dr Reddy’s on Friday said its active pharmaceutical ingredient (API) manufacturing facility in Bollaram, Hyderabad (CTO-3), completed US Food & Drug Administration (USFDA)’s GMP (good manufacturing practices) inspection with zero observations.

The inspection was conducted from June 12, 2023 to June 16, 2023.

The company also said it has received establishment inspection report (EIR) for its formulations manufacturing unit in Srikakulam (FTO SEZ PU2), Andhra Pradesh.

EIR means closure of inspection.

The Agency has classified the inspection as Voluntary Action Indicated (VAI) and concluded that the inspection is “closed”, the company said in a statement to stock exchanges.

The successful clearance of GMP inspection will enable Dr Reddy’s to launch new product and mitigate impact of price.

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