EU lifts ban on Ranbaxy API plant at Toansa
Decision comes after European agency finalizes its assessment of reported non-compliance with good manufacturing practice
Mumbai: The European Union (EU) has lifted its ban on drugs produced at Ranbaxy Laboratories Ltd’s Toansa factory in Punjab, the grouping’s health regulator, European Medicines Agency (EMA), said on Friday.
“Medicines produced at the site posed no risk to public health despite having a number of manufacturing deficiencies," the agency said in a statement.
The EU had banned drugs produced at the Toansa factory from being sold in its 28 member-countries this year, following a similar action by the US in 2013.
The decision came after the European regulatory agency finalized its 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 but an assessment of all available information had satisfied regulators that there was no risk to public health from these deficiencies, EMA said.
The EU will reinstate the GMP certificate it suspended in January 2014. The certificate will be re-entered into the EudraGMDP, the EU database that contains GMP certificates, EMA added.
EMA’s assessment of the Toansa facility followed an inspection by the US Food and Drug Administration (US FDA), which revealed areas of non-compliance with GMP.
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