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The company last week had said it will submit "suitable clarifications" to European Medicines Agency (EMA) over the decision to review two drugs.
Updated : Mar 21, 2018, 05:53 AM IST
The shares of Alkem Laboratories plunged over 7% on Monday amid concerns that the European Medicines Agency (EMA) is reviewing some of its drugs following a red flag over clinical trial studies.
The stock slumped 7.45% to Rs 1,236 on the BSE. On NSE, it declined 7.66% to Rs 1,236.40.
The review of the drugs, which include anti-biotics cefuroxime and rulizole used to treat neurological disorder amyotrophic lateral sclerosis and sold both by Alkem and Slovenia's Krka, has been ordered after the German drug regulator raised concerns about trial study data.
Alkem conducted trials on the drugs at its Taloja facility in Maharashtra for Krka.
Meanwhile, Alkem on Saturday said it will submit "suitable clarifications" to EMA over the decision to review two drugs.
"We will be submitting suitable clarifications to EMA within the stipulated timeline to enable the Committee for Medicinal Products for Human Use (CHMP) to take a balanced risk-benefit view with respect to these two products," Alkem had said in a regulatory filing.
At 1306 hours, the shares of Alkem Laboratories recovered slightly from its early morning level but was still trading down 4.31% or Rs 57.50 at Rs 1,278.00 per scrip on the BSE.