Biocon, Dr Reddy’s Might Be Out Of The Woods On GMP Issue

Two Indian firms – Biocon and Dr Reddy’s – have received crucial establishment inspection reports (EIRs) from the US FDA amid improved compliance levels at their manufacturing sites.

GMP
BIOCON AND DR REDDY'S HAVE MADE PROGRESS ON THE COMPLIANCE FRONT

Two Indian firms seeking to set right compliance deviations at their sites appear to have made notable gains. Biocon Ltd. and Dr. Reddy's Laboratories Ltd. have received establishment inspection reports [EIRs] from the US Food and Drug Administration at their sites in Bangalore and Duvvada respectively in India.

The EIR for the Biocon’s aseptic drug product facility states that the inspection stands closed, though the FDA has classified...

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