Ranbaxy’s two plants remain debarred from export to EU

Export of medicine manufactured at Ranbaxy’s Toansa and Dewas facility to Europe will remain debarred. The European Medicines Agency (EMA) said that Indian authorities have withdrawn the certification of manufacturing standards from Toansa plant, while an international inspection of the Dewas plant has been planned for June 2014.

EMA spokesperson said the EMA and national medicines authorities in the EU are progressing with their assessment of reports of non-compliance with Good Manufacturing Practice (GMP) at two Ranbaxy Laboratories' sites in India. The EMA and national medicines authorities in the EU are working together to ensure that failings previously identified at the site are fully resolved before there is a resumption of exports from the site to the manufactures in the EU.

Ranbaxy had voluntarily revoked exports from the sites to the EU in January 2014. The second unannounced international investigation of the Toansa facility was conducted after the USFDA banned products from the plant in January. The initial findings of the inspection carried out collectively by authorities from Germany, the UK, Ireland, Switzerland and Australia did not highlight any additional issues beyond those already identified. The Toansa site had been supplying APIs for four centrally authorised medicines - Enyglid (repaglinide), Repaglinide Krka (repaglinide), Repaglinide Teva (repaglinide), and Nevirapine Teva (nevirapine) and several non-centrally authorised medicines in Europe.