The European health regulator, on Thursday, lifted the suspension imposed on export of drugs produced at the Ranbaxy’s Toansa plant to the 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 European regulatory authorities have finalised their assessment of reported non-compliance with Good Manufacturing Practice (GMP) at the Toansa plant. “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.
As a consequence, the EU authorities will reinstate the GMP certificate which was suspended in January. The certificate will be re-entered into EudraGMDP, the EU database that contains GMP certificates, EMA added.
