EMA lifts drug export ban on Ranbaxy’s Toansa manufacturing plant

European regulatory authorities have finalized their assessment of reported non-compliance with Good Manufacturing Practice (GMP) at Toansa site that had led to the suspension of the GMP certificate for the site in the European Union (EU).

The assessment demonstrated that there were a number of GMP deficiencies at the concerned site and the evaluation of all available information has reassured European regulators that there has been no risk to public health from these deficiencies.

According to EMA, patients should continue to take their medicines as prescribed by their healthcare professional.

The regulators also considered the corrective measures put in place by Ranbaxy and were satisfied that the measures are sufficient to ensure GMP-compliant manufacture of products at the site.

EMA added that as a consequence, the EU authorities will reinstate the GMP certificate which was suspended in January 2014, while it will be re-entered into EudraGMDP, the EU database that contains GMP certificates.

The evaluation at Toansa facility by EMA followed an inspection by the US Food and Drug Administration (FDA) which revealed areas of non-compliance with GMP at the site.

EMA said in a statement "The European medicines regulatory network responded quickly 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."