Ranbaxy’s Toansa plant assessment concluded: no risk to public health, EU view

European regulatory authorities have finalized their assessment of reported non-compliance with Good Manufacturing Practice (GMP) at Indian drugmaker Ranbaxy Laboratories’ (BSE: 500359) manufacturing site in Toansa, India, that had led to the suspension of the GMP certificate for the site in the European Union, regulators have concluded.

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 Ranbaxy, currently majority-owned by Japan’s Daiichi Sankyo but now the  subject of a $4 billion takeover by Indian rival Sun Pharmaceuticals.

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.