The European Medicines Agency (EMA) has recommended a recall of Acino’s generic Plavix (clopidogrel bisulfate) because of alleged failings in GMP at the API production facility.
Glochem Industries manufactures the active pharmaceutical ingredient (API), clopidogrel, at its plant in Visakhapatnam, India. Concerns about compliance with good manufacturing practices (GMP) at the site have prompted the recommendation that eight Acino products are recalled.
The recommendation was made by the EMA’s Committee for Medicinal Products for Human Use (CHMP) following an inspection of the plant. This raised concerns about API production processes and the quality of medicines using clopidogrel from the site, according to the EMA.
Furthermore, the CHMP recommended that the Visakhapatnam facility is removed from the list of sites allowed to supply clopidogrel to Acino. Alternative suppliers of clopidogrel are available and Acino plans to use these to ensure it can quickly resume supplying the products.
Swiss-based Acino has responded by claiming the regulatory inspection “detected no deficiencies of product quality”. It added that inspecting authorities performed a comprehensive risk assessment and analysis of the API and “explicitly stated” that a recall is unnecessary.
Neither the EMA nor Acino have received reports raising concerns about the medicines from patients, pharmacists or prescribers. Acino, which described the recall as “neither necessary nor purposeful”, added that patients can use medicines they have already received.
Sanofi-Aventis, the developer and manufacturer of clopidogrel containing medicines, including Plavix, issued a release confirming the quality and supply of its products.
Clopidogrel for three of these products, Plavix, Iscover and Clopidogrel Winthrop, is manufactured at four Sanofi sites in France one in the UK. API for Trombex is sourced from sites in Hlohovec, Slovakia.