EMA wants recall of Acino’s generic clopidogrel with active substance of Indian Glochem Posted 02/04/2010

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) recommended the recall of all batches of eight centrally-authorised generic clopidogrel-containing medicines, for which the active substance was manufactured by Glochem Industries Ltd 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 is Acino Pharma GmbH.

Clopidogrel (brand name: Plavix) is an antiplatelet medicine that is used to prevent problems with blood clots such as heart attacks or strokes. Plavix is sold as a brand by sanofi-aventis and Bristol-Myers Squibb. It is the world's second biggest selling medicine, with worldwide sales of more than US$9 billion a year, as reported by Reuters. However, the medicine is off patent in some European markets, where Acino is among the companies that have been supplying a cheaper generic version.

While neither the regulatory authorities nor the marketing authorisation 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.

The Committee’s recommendation follows an inspection of the Glochem Visakhapatnam manufacturing site, which identified failings in Good Manufacturing Practices (GMP). The GMP failings raised concerns about the processes used to manufacture the active substance and the Committee was not reassured about the quality of medicines made with clopidogrel from this manufacturing site. The CHMP’s opinion has now been forwarded to the European Commission for the adoption of a legally binding decision.

Europe's drugs watchdog said on 25 March 2010 it was taking the action because of GMP failure at a factory in Visakhapatnam, India, where the active substance for Acino's product is produced.

While there have been no reports raising concerns from patients, pharmacists or prescribers, agency experts decided a recall was the appropriate precautionary measure. Its recommendation that clopidogrel made at the Glochem Visakhapatnam factory be removed from the supply chain, starting at the level of pharmacists, has now been forwarded to the European Commission for the adoption of a legally binding decision.

References:

Ben Hirschler. Update 2-EU plans recall of Indian-made generic Plavix. Reuters. 2010 March 25.

European Medicines Agency recommends precautionary recall of batches of clopidogrel-containing medicines from Acino Pharma GmbH. EMA Press Release. 2010 March 25.

Source: Reuters; EMA Press Release

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