Dr Reddy's says US FDA has closed Miryalaguda plant audit

By Gareth Macdonald contact

- Last updated on GMT

Dr Reddy’s Laboratories says it has addressed the problems that earned its API plant in Miryalaguda, Talangana a US FDA Form 483 earlier this year.

The Indian drug and active pharmaceutical ingredient (API) firm reported receipt of an (Establishment Inspection Report) EIR in a Bombay Stock Exchange filing​ last night.

A spokeswoman for the firm told us the "EIR indicates that the audit of our API plant in Miryalguda is closed and the observations made earlier by US FDA are satisfactorily addressed."

The Form 483 - which was issued by the US Food and Drug Administration 9FDA) after a six day inspection in February - included three obsevrations, details of which have never been made public.

Form 483s

The Miryalaguda site – which is known as CTO Unit V - makes active pharmaceutical ingredients (APIs) for a range of medicines, including treatments for cardiovascular diseases and cancer. 

It supplies ingredients for Dr Reddy’s own products and for drug manufacturers supplying India and international markets.

The site is one of four Dr. Reddy’s plants issued with a Form 483 this year.

The other facilities are its finished dosage form site in Duvvada​, its API plant in Srikakulam​ and its generic drug facility in Bachupally​.

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