Indoco Remedies has received Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its sterile facility (Plant II) and solid dosages facility (Plant III) at Verna, Goa. The inspection was carried out between October 7 to 15, 2019. This was a Pre-Approval Inspection for a sterile injectable product, with 2 observations on Form 483s, which is now concluded as closed.
The inspection classification of this site has been determined as VAI (Voluntary Action Indicated) by the USFDA.
Indoco Remedies is engaged in the manufacturing and marketing of formulations (finished dosage forms) and active pharmaceutical ingredients (APIs) in India.
Company Name | CMP |
---|---|
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