EMA calls for generic clopidogrel recall
Problems at a manufacturing facility in India have resulted in eight generic version of the antiplatelet agent clopidogrel being recalled from the market in Europe.
All of the products used a clopidogrel besylate active pharmaceutical ingredient (API) manufactured by Glochem Industries under a contract with Swiss drugmaker Acino Pharma, which has seen its shares hit hard as a result.
The recall affects Acino's product as well as other versions it licenses to other generic manufacturers including Sandoz, Ratiopharm and Hexal. Clopidogrel accounted for a quarter of Acino's sales in 2009 and is its biggest product.
The European Medicines Agency (EMA) said its Committee for Medicinal Products for Human Use (CHMP) recommended the recall after an inspection of Glochem's manufacturing facility in Visakhapatnam by German regulatory authorities found several deviations from Good Manufacturing Practice (GMP).
In a statement, the EMA said the German inspection "raised concerns about the processes used to manufacture the active substance" and that it had recommended the recall as a "precautionary measure".
For its part, Acino maintains that the German inspectors' report "explicitly stated that there is no necessity for a recall recommendation", and found "no quality deficiencies" relating to clopidogrel products from Acino.
The company says that it has alternative supplies of the API and will start deliveries again shortly. However, it conceded that if individual country authorities request a recall, the resulting write-down of existing and returned goods "would in all likelihood have a significant negative impact on the annual result 2010".
Clopidogrel was originally developed by Sanofi-Aventis and Bristol-Myers Squibb which sell it under the Plavix and Iscover brand names, and is the world's second biggest-selling medicine bringing in $9.1 billion last year. The originator products - based on clopidogrel hydrogen sulfate - are unaffected by the recall.
Last week, Sanofi-Aventis was given a green light by an EMA advisory committee for a combination of clopidogrel and aspirin called DuoPlavin that is indicated to treat heart disease.