Alkem Laboratories shares fell over 7 per cent intraday after the European Medicines Agency (EMA) on Friday said it is reviewing some drugs following a red flag over their clinical trial studies.
Alkem Laboratories shares fell over 7 per cent intraday on Monday after the European Medicines Agency (EMA) on Friday said it is reviewing some drugs following a red flag over their clinical trial studies.
At 10.13 am, Alkem Laboratories shares were trading 4.66 per cent down at Rs 1,273.25. The scrip opened at Rs 1,285.00 and has touched a high and low of Rs 1,285.00 and 1,236.00, respectively in trade so far. Sensex was trading 81.36 points up at 25,708.11 during the same time.
The review of the drugs, that include antibiotics cefuroxime and rulizole, used to treat neurological disorder amyotrophic lateral sclerosis and sold both by Alkem and Slovenia’s Krka, has been ordered after German drug regulator’s raised concerns over trial study data.
Alkem conducted trials on the drugs at its Taloja facility in Maharashtra for Krka.
In a notice, EMA said, “This follows a good clinical practice (GCP) inspection of this site which raised concerns regarding study data used to support the marketing authorisation applications of some medicines in the EU.”
The company on Saturday said it will submit ‘suitable clarifications’ to the European Medicines Agency (EMA) over a decision by the drug regulator to review two drugs for which clinical trial studies were conducted by the Mumbai-based firm.