Lupin submits fresh studies for two products suspended by EMA

Drug firm Lupin has submitted fresh studies to the European Medicines Agency (EMA) for two products, which are among 700 generic drugs suspended by the health regulator due to flawed clinical trial data provided by GVK Bio.
"The company has successfully conducted the new bio equivalence (BE) studies for the said products and submitted the report in May 2015 for review by EMA," Lupin Ltd said in a regulatory filing.
The Mumbai-based firm along with many other companies had received communication from EMA for suspension of Trimetazidine MR 35 mg and Cefpodoxime 200 mg tablets in January 2015.
The EU drug regulator had suspended the marketing authorisation of around 700 generic drugs on the grounds that their approvals were supported by "flawed" clinical trial data provided by the Hyderabad-based GVK Bio.

It had urged the European Commission to take a legally binding decision to ban the concerned drugs unless the marketing authorisation holder submits the results of a new bio-equivalence study.
Lupin had informed the EMA that it will submit new BE studies for Trimetazidine Cefpodoxime tablets by June 2015.

"We wish to add that, the company also submitted the new BE study reports to various customers for their external review purpose.
Another drug maker Dr Reddy's Laboratories, whose products were also suspended by the EMA, said: "The overall impact on the company's financials of this development is expected to be quite insignificant."

Lupin shares were trading at Rs 1,749.75 apiece on BSE, down 0.28 per cent from previous close.