Glenmark Pharma Gets USFDA Nod for Two Generic Drugs
BANGALORE: Glenmark Pharma said it has received final approval from the USFDA to manufacture and market Potassium Chloride extended release capsules and oral contraceptive Norethindrone Acetate and Ethinyl Estradiol tablets in the American market.
"Glenmark Pharmaceuticals Inc has been granted final approval by the U.S. Food and Drug Administration (USFDA) for Potassium Chloride extended release capsules USP, 10mEq, of Actavis Laboratories FL, Inc," the company said in a BSE filing.
Quoting IMS data, Glenmark Pharma said the approved product has an estimated market size of USD 74.1 million for the 12 months ended November 2015.
The company has also received approval for Norethindrone Acetate and Ethinyl Estradiol tablets. It is a generic version of U.S.-based Warner Chilcott's oral contraceptive drug 'Leostrin21' "The approved product has an estimated market size of $56.8 million for the 12 months ending November 2015, according to IMS," Glenmark Pharma added. Glenmark Pharma's current portfolio consists of 62 ANDAs pending approvals from the USFDA and 106 products authorised for distribution in the US.
Shares of the company were trading at 
770.25 a piece, down 2.03 percent, from their previous close on the BSE.
Glenmark stock price
On January 21, 2016, at 15:21 hrs Glenmark Pharma was quoting at 737.70, down 48.55, or 6.17 percent. The 52-week high of the share was 1261.95 and the 52-week low was 705.00.
The company's trailing 12-month (TTM) EPS was at 52.77 per share as per the quarter ended September 2015. The stock's price-to-earnings (P/E) ratio was 13.98. The latest book value of the company is 175.54 per share. At current value, the price-to-book value of the company is 4.20.
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