New Delhi : European health regulator on Thursday lifted suspension imposed on export of drugs produced at Ranbaxy’s Toansa plant to the EU stating medicines produced at the site posed no risk to public health despite having a number of manufacturing deficiencies, reports PTI.
In a statement, the European Medicines Agency (EMA) said European regulatory authorities have finalised their assessment of reported non-compliance with Good Manufacturing Practice (GMP) at the Toansa plant.
“There were a number of GMP deficiencies at the concerned site, assessment of all available information has reassured European regulators that there has been no risk to public health from these deficiencies,” it said.
As a consequence, the EU authorities will reinstate the GMP certificate which was suspended in January 2014.
Ranbaxy had voluntarily suspended exports from the Toansa plant to the EU in January 2014 after US Food and Drug Administration (USFDA) had banned the company from exporting drugs produced at the plant to be sold in the US.
On the status of remedial measures taken up by the company, it said: “The GMP inspection concluded that appropriate corrective and preventive measures have been put in place by the manufacturer.”
The Toansa site had been supplying APIs (active pharmaceutical ingredients) for four centrally authorised medicines– Enyglid (repaglinide), Repaglinide Krka (repaglinide), Repaglinide Teva (repaglinide), and Nevirapine Teva (nevirapine) – and several non-centrally authorised medicines.
Suspension of export to EU from the company’s other plant at Dewas in Madhya Pradesh, however, remains.