Although the assessment revealed “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,” the EMA said in a statement.
European regulators also considered the corrective measures put in place by the company and said they were satisfied that the measures are sufficient to ensure GMP-compliant manufacture of products at the site.
The site’s certificate will be re-entered into EudraGMDP, the EU database that contains GMP certificates.
The recent assessment of the site followed an inspection by the US FDA, which revealed areas of non-compliance with GMP at the site. The FDA refused to import products from the site, and in February, Ranbaxy voluntarily halted all production at the facility.
The Toansa site supplied APIs for four centrally authorised medicines – Enyglid (repaglinide), Repaglinide Krka (repaglinide), Repaglinide Teva (repaglinide), and Nevirapine Teva (nevirapine) – and several non-centrally authorised medicines.
The European medicines regulatory network “responded quickly” to the FDA’s findings, the EMA says, 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. This conclusion was supported by tests of samples of these medicines, all of which met the correct quality specifications.
European regulatory authorities have identified the need to keep the Toansa site under close supervision and this will be done in collaboration with India and other regulatory authorities around the globe.
As a result of the reversal, two GMP certificates have been issued by EU authorities - one covering APIs that used in medicines authorised in the EU, and a second certificate covering an intermediate of a finished medicine authorised in the EU.