Ranbaxy's EU exports to remain suspended

Exports from Ranbaxy plants at Toansa and Dewas to Europe will remain suspended as probes are continuing even as Indian authorities have withdrawn the certification of manufacturing standards from one of the units, European health regulator EMA said on Wednesday.

The European Medicines Agency (EMA) said that Indian authorities have withdrawn certification to the Toansa plant, while an international inspection of the Dewas plant has been planned for June 2014.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 told PTI.

 

Exports from Toansa and Dewas sites to the EU will remain suspended, the spokesperson said without specifying a timeline for completion of investigations.

 

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.