Dr Reddy's gets EIR for Nalgonda-based API plant

Dr Reddy's gets EIR for Nalgonda-based API plant
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  • India

Dr Reddy's Laboratories on Thursday said it has received an establishment inspection report (EIR) from the US health regulator for its Nalgonda-based active pharmaceutical ingredient (API) manufacturing unit. "With regard to the audit of our API manufacturing plant 5 at Miryalaguda, Nalgonda district, Telangana, we would like to inform you that we have received the EIR from the USFDA, for the above-referred facility, indicating closure of the audit," the Hyderabad-based company said in a regulatory filing.

The inspection classification of this facility is determined as "voluntary action indicated" (VAI), it added. USFDA issues an EIR to a company when an inspection is satisfactorily closed.

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