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EU clopidogrel recall suggested after India plant fails GMP inspection

This article was originally published in The Gold Sheet

Executive Summary

The European Medicines Agency's Committee for Medicinal Products for Human Use on March 25 recommended a recall to the pharmacy level of all clopidogrel products made for the European market with active pharmaceutical ingredient that was produced by Glochem Industries at its plant in Visakhapatnam, India. Inspectors from Germany acting for EMA determined in an inspection that the plant was not compliant with EU GMPs. Swiss-based Acino Pharma markets clopidogrel, generic for Plavix, with API made from the site, as do its marketing partners A1 Pharma, Hexal, Sandoz and ratiopharm

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