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Lupin Ltd has confirmed that it was among the pharma companies that had received communication from the European Medicines Agency (EMA) with regard to suspension of some medicines.
However, the company said that it had conducted new Bio Equivalence (BE) studies for the products concerned and submitted the report this month for review by the EMA.
Responding to a query from the BSE on reports appearing in the media that "some drugs made by Lupin, DRL & Mylan lose EU approval", Lupin Ltd said that with respect to GVK Bio Eqivalence (BE) studies , "the company along with many other companies in the EU" received communication from European Medicines Agency (EMA) for suspension of Trimetazidine MR 35mg. tablets and Cefpodoxime 200mg. tablets in January this year.
Lupin said that it had communicated to the EMA that it would present new BE studies for both tablets to the EMA by June. The pharma major said that it had successfully conducted the `new BE studies for the said products and submitted the report in May 2015 for review by EMA’.
Shares of Lupin are up by ₹11 at ₹1764 on the NSE. The stock had touched a high of ₹1797.80 on the exchange before paring some of its gains.
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