Days after the U.S. Food and Drug Administration banned import of Ranbaxy products to America from its Toansa plant, health regulators of the EU and the U.K. have said they are evaluating the FDA inspection findings to assess if deviations from Good Manufacturing Practice (GMP) have any implication in their markets.
The European Medicines Agency (EMA), a body under the European Union, said Ranbaxy Laboratories site in Toansa, Punjab, is a supplier of active ingredients for four centrally authorised medicines Enyglid (repaglinide), Repaglinide Krka (repaglinide), Repaglinide Teva (repaglinide) and Nevirapine Teva (nevirapine), besides several non-centrally authorised medicines.
“The EMA and national medicines authorities in the EU have been informed of the recent FDA inspection findings and prohibition of importation or distribution within the U.S. of active pharmaceutical ingredients (APIs) from the Ranbaxy Laboratories’ site in Toansa, India, due to deviations from Good Manufacturing Practice (GMP) identified during the inspection in Toansa,” the EMA told PTI in an email reply.
“European authorities are now evaluating the FDA inspection findings, which have been shared under confidentiality arrangements.
“They are also evaluating information requested from the marketing authorisation holders in the EU and from Ranbaxy itself, in order to assess the impact that these GMP deficiencies may have on medicines on the EU market,” the EMA said.