Hyderabad: Days after the US Food and Drug Administration (FDA) banned import of Ranbaxy products to America from its Toansa plant, health regulators of the EU and the UK have said they are evaluating the FDA inspection findings to assess if deviations from good manufacturing practice (GMP) have any implication in their markets.
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 US 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," EMA told PTI in an email reply.
"European authorities are currently evaluating the FDA inspection findings, which have been shared under confidentiality arrangements."
Citing manufacturing norm violations, the FDA had last week prohibited Ranbaxy Laboratories from distributing drugs produced at the Toansa unit in the US, including medicines made by the company's Ohm Laboratories facility in New Jersey.
The Medicines and Healthcare Products Regulatory Agency (MHRA) of UK said they are aware of the results of the FDA's inspection relating to GMP issues at the Toansa plant.
MHRA said as of now, they found no evidence that Ranbaxy's medicines in the UK are defective, so people can continue to consumes them as usual.
"We are aware of the results of the FDA's inspection relating to Good Manufacturing Practice (GMP) issues at Ranbaxy's Toansa plant in India," an MHRA spokesperson said.
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 US 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," EMA told PTI in an email reply.
"European authorities are currently evaluating the FDA inspection findings, which have been shared under confidentiality arrangements."
Citing manufacturing norm violations, the FDA had last week prohibited Ranbaxy Laboratories from distributing drugs produced at the Toansa unit in the US, including medicines made by the company's Ohm Laboratories facility in New Jersey.
The Medicines and Healthcare Products Regulatory Agency (MHRA) of UK said they are aware of the results of the FDA's inspection relating to GMP issues at the Toansa plant.
MHRA said as of now, they found no evidence that Ranbaxy's medicines in the UK are defective, so people can continue to consumes them as usual.
"We are aware of the results of the FDA's inspection relating to Good Manufacturing Practice (GMP) issues at Ranbaxy's Toansa plant in India," an MHRA spokesperson said.
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