European health regulator has lifted its suspension imposed on export of drugs produced at Ranbaxy’s Toansa plant to the European Union (EU) stating medicines produced at the site posed no risk to public health despite having a number of manufacturing deficiencies.
In a statement, the European Medicines Agency (EMA) said that European regulatory authorities have finalised their assessment of reported non-compliance with Good Manufacturing Practice (GMP) at the Toansa plant that had led to the suspension of the GMP certificate for the site.
“Although the assessment showed that 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 adding that patients should continue to take their medicines as prescribed by their healthcare professional.
European regulators also considered the corrective measures put in place by the company and were satisfied that the measures are sufficient to ensure GMP-compliant manufacture of products at the site.
As a consequence, the EU authorities will reinstate the GMP certificate which was suspended in January 2014. The certificate will be re-entered into EudraGMDP, the EU database that contains GMP certificates.
The assessment followed an inspection by the US Food and Drug Administration (FDA) which revealed areas of non-compliance with GMP at the site. The European medicines regulatory network responded to the FDA’s findings, and sent a team of inspectors from Germany, Ireland and the UK, who were joined by inspectors from Switzerland and Australia to undertake an unannounced international inspection of the site.
The GMP inspection concluded that appropriate corrective and preventive measures have been put in place by the manufacturer. The inspection team concluded that there was no evidence that any medicines on the EU market that have an active pharmaceutical ingredient manufactured in Toansa were of unacceptable quality or presented a risk to the health of patients taking them.
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.
Two GMP certificates have been issued by EU authorities - one covering active pharmaceutical ingredients that are used in medicines authorised in the EU, and a second certificate covering an intermediate of a finished medicine authorised in the EU.
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.
This comes as a major relief for Ranbaxy as well as Sun Pharma, which is in the process of acquiring Daiichi Sankyo-controlled Ranbaxy.
(Edited by Joby Puthuparampil Johnson)