The Company has successfully conducted the new BE studies for the said Products and submitted the report in May 2015 for review by EMA
The Exchange had sought clarification from Lupin Ltd with respect to news article appearing in Financial Express on May 22, 2015 titled "Some drugs made by Lupin, DRL & Mylan lose EU approval"
Lupin Ltd clarified that in connection with 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 2015.
The Company informed the EMA that it will submit new BE studies for Trimetazidine MR 35mg. tablets and Cefpodoxime 200mg. tablets to EMA by June 2015.
The Company has successfully conducted the new BE studies for the said Products and submitted the report in May 2015 for review by EMA."
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