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

 
• By Anju Ghangurde

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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More from Compliance

ICH Proposes Global Framework For Managing Leachables In Pharma Products

 
• By Vibha Sharma

The International Council for Harmonisation has developed a holistic approach for the assessment and control of leachable impurities, supporting drug product development, registration and ongoing quality management throughout the product lifecycle.

50% Levy On India And Brazil, US Tariffs Leave Global Trade, Forecasts In Disarray

 
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Manufacturers Can Keep Their Shoes On: FDA PreCheck To Streamline US Facility Applications

 
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