EMA Reinstates Ranbaxy's GMP Certificate for Toansa, India Facility

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 06-05-2014 13:36


European regulatory authorities have finalized their assessment of reported non-compliance with good manufacturing Practice (GMP) at Ranbaxy Laboratories’ manufacturing site in Toansa, India that had led to the suspension of the GMP certificate for the site in the European Union (EU).

"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," said EMA in a statement. "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 that 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," said EMA in a statement. "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.

The Toansa site had been supplying APIs for four centrally authorized medicines–three different forms of repaglinide and nevirapine and several non-centrally authorized medicines. Two GMP certificates were issued by EU authorities, one covering active pharmaceutical ingredients that are used in medicines authorized in the EU, and a second certificate covering an intermediate of a finished medicine authorized in the EU.

Separately, in January 2014, FDA issued a consent decree to Ranbaxy to prohibit it from manufacturing and distributing APIs for FDA-regulated drug products from its facility in Toansa, India. Under that decree, the FDA is prohibiting Ranbaxy from distributing in the United States drugs manufactured using APIs from Toansa, including drugs made by Ranbaxy’s Ohm Laboratories facility in New Jersey; manufacturing APs at its Toansa facility for FDA-regulated drug products; exporting APIs from Toansa to the United States for any purpose; and providing API from Toansa to other companies, including other Ranbaxy facilities, making products for American consumers.

Source: EMA

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