Exports from Ranbaxy plants at Toansa and Dewas to Europe will remain suspended as investigations are continuing even as Indian authorities have withdrawn the certification of manufacturing standards from one of the units, European health regulator EMA said Wednesday.
The European Medicines Agency (EMA) said that Indian authorities have withdrawn certification to the Toansa plant, while an international inspection of the Dewas plant has been planned for June 2014.
“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,” a EMA spokesperson said.
On the Toansa plant, the official said: “On March 26, 2014, Indian authorities withdrew the site’s ‘Written Confirmation’, effectively making the suspension of the exports official for the time being.”
The Written Confirmation is a document that accompanies all APIs (active pharmaceutical ingredients) exported to the EU to certify that relevant manufacturing standards have been met.
“In the meantime, the EMA and national medicines authorities in the EU are continuing to work 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,” it said.
Ranbaxy had voluntarily suspended exports from the sites to the EU in January 2014.
The EMA said a second unannounced international probe of the Toansa site was conducted after the USFDA banned products from the plant in January. The preliminary findings of the inspection carried out jointly 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.
When contacted a Ranbaxy spokesperson declined to comment.
