EMEA recalls batches of generic Plavix; Sun Pharma withdraws EU marketing application for Repaglinide SUN

European Medicines Agency (EMEA) yesterday afternoon recommended a precautionary recall of batches of clopidogrel-containing medicines from Acino Pharma GmbH and has revealed that an application for a copy version of a diabetes drug has been withdrawn.

The EMEA's Committee for Medicinal Products for Human Use (CHMP) proposed the recall of all batches of eight centrally-authorized generic clopidogrel-containing medicines, for which the active substance was manufactured by Glochem Industries in its factory in Visakhapatnam (India). The medicines concerned are Clopidogrel A1 Pharma, Clopidogrel Acino, Clopidogrel Acino Pharma, Clopidogrel Acino Pharma GmbH, Clopidogrel Hexal, Clopidogrel Ratiopharm, Clopidogrel Ratiopharm GmbH and Clopidogrel Sandoz. The Marketing Authorisation Holder of all these medicines, which are the active ingredient of French drug major Sanofi-Aventis' Plavix, is Acino Pharma GmbH.

While neither the regulatory authorities nor the marketing authorization holder have received reports raising concerns about these medicines from patients, pharmacists or prescribers, the CHMP recommended, as a precautionary measure, that all batches using clopidogrel made at the Glochem Visakhapatnam factory be recalled from the supply chain starting at the level of pharmacists. The Committee also recommended that the Glochem Visakhapatnam manufacturing site be removed from the list of sites allowed to supply clopidogrel to Acino Pharma GmbH for their generic medicines.