Marksans Pharma Jumps Despite U.S. Drug Regulator’s Concerns
The U.S. FDA issued four observations under 483 after inspection at its Goa facility.
Shares of Marksans Pharma on Monday rose nearly 9 percent, the highest intraday gain since February 20, on high trading volumes.
The U.S. Food and Drug Administration (U.S. FDA) issued four observations under Form 483 after completing an inspection at the company’s Goa facility between April 3 and 7, Marksans Pharma said in a stock exchange filing. The company said it has started addressing these observations and is confident of satisfying the drug regulator’s concerns within the stipulated time.
Form 483 is used by the FDA to document and communicate concerns discovered during plant inspections.
The Goa facility was inspected by the U.K. drug regulator in February this year and by the U.S. drug regulator in August 2015 without any critical observations.
Seperately, Marksans Pharma received approval of the Abbreviated New Drug Approval (ANDA) for Dutasteride Soft Gelatin Capsules – therapeutically equivalent to reference listed drug (RLD) Avodart capsules of GlaxoSmithKline used to treat symptoms caused by enlarged prostate. The company said it plans to introduce the product immediately.
The stock was trading at 12.7 times its 20-day average volumes as of 2:10 p.m. on the National Stock Exchange. It has risen 17 percent in the past month, compared with an average 1.2 percent decline for pharmaceutical companies tracked by Bloomberg.
Marksans Pharma trades at 29.5 times trailing 12-month earnings per share and 87 times its estimates for the coming year. The stock is 25 percent higher than the Bloomberg consensus one-year target price.