 "Alkem Laboratories nears lowest level since listing")
Alkem Laboratories has dipped 7% to Rs 1,236 on the BSE in early morning trade amid media reports that the company has been accused by Germany’s health regulator of fudging data on clinical trials of an antibiotic and brain disorder drug.
On clarification of news report, Alkem Laboratories said after the inspection of March 2015 by German regulator, the Federal Institute of Drug and Medical Devices (BfArM), Alkem has responded to the regulator with a robust remedial plan and has also been implementing several measures which include changes in staffing, upgrading equipment and improving quality assurance systems to ensure proper controls during bioequivalence studies and thorough review of the acquired data.
Currently sales from Europe contribute less than 1% to Alkem’s total consolidated sales for 9MFY16, it added.
In March, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) made eight observations following an inspection at the Taloja plant. Alkem had then said it was responding to the UK health regulator’s observations and did not anticipate any impact on the products it supplies to Europe at present.
At 09:44 am, the stock was down 5% at Rs 1,265 as compared to 0.23% rise in the S&P BSE Sensex. A combined 195,033 shares changed hands on the counter on the NSE and BSE.
Currently, the stock is trading close to lowest level since its listing in December last year. It touched a low of Rs 1,232 on February 26, 2016 in intra-day trade.
Generic drug maker Alkem Labs had raised Rs 1,350 crore through initial public offer by issuing shares at price of Rs 1,050 per share.
On clarification of news report, Alkem Laboratories said after the inspection of March 2015 by German regulator, the Federal Institute of Drug and Medical Devices (BfArM), Alkem has responded to the regulator with a robust remedial plan and has also been implementing several measures which include changes in staffing, upgrading equipment and improving quality assurance systems to ensure proper controls during bioequivalence studies and thorough review of the acquired data.
Currently sales from Europe contribute less than 1% to Alkem’s total consolidated sales for 9MFY16, it added.
In March, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) made eight observations following an inspection at the Taloja plant. Alkem had then said it was responding to the UK health regulator’s observations and did not anticipate any impact on the products it supplies to Europe at present.
At 09:44 am, the stock was down 5% at Rs 1,265 as compared to 0.23% rise in the S&P BSE Sensex. A combined 195,033 shares changed hands on the counter on the NSE and BSE.
Currently, the stock is trading close to lowest level since its listing in December last year. It touched a low of Rs 1,232 on February 26, 2016 in intra-day trade.
Generic drug maker Alkem Labs had raised Rs 1,350 crore through initial public offer by issuing shares at price of Rs 1,050 per share.