Regulators in Europe has recommended the recall of all batches of generic Plavix made for the Swiss firm Acino Pharma at a facility in India following an inspection that raised concerns about the quality of the antiplatelet being produced there.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the recall of all batches of eight copycat versions of Sanofi-Aventis/Bristol-Myers Squibb’s blockbuster Plavix (clopidogrel), for which the active substance was manufactured by Glochem Industries in its factory in Visakhapatnam, India. The marketing authorisation holder of all these medicines is Acino, but some of them are sold by Novartis’ Hexal and Sandoz units and Ratiopharm, which is to be acquired by Teva Pharmaceutical Industries.

While neither the regulatory authorities nor Acino have received reports raising concerns about these medicines, the CHMP has recommended their recall from the supply chain “starting at the level of pharmacists” as a precautionary measure. It has taken the step after an inspection of the Glochem site, which identified failings in Good Manufacturing Practices which “raised concerns about the processes used to manufacture the active substance”.

The Committee added it was “not reassured about the quality of medicines” produced at Visakhapatnam and its opinion has now been forwarded to the European Commission “for the adoption of a legally-binding decision”.

Plavix is off-patent in a number of European countries and Acino moved quickly to get its version out. Now the Basel-headquartered group says that the CHMP inspection “detected no deficiencies of product quality” and Acino and its marketing partners “follow the conclusion of the inspecting authorities and consider a withdrawal of the clopidogrel products in question neither necessary nor purposeful”.

The company adds that “owing to existing alternative suppliers of active ingredient, Acino expects to restore delivery readiness shortly”. It added however that while the outlook for 2010 is “cautiously optimistic”, should individual country authorities, “which are free in their decision”, request a recall, this would “in all likelihood have a significant negative impact on the annual result”.

Stockholders are concerned and Acino shares were down 10.8% at 150.50 Swiss francs at 11.45 (UK time).