Glenmark Pharma today 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 US Food and Drug Administration (US FDA) 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 US-based Warner Chilcott’s oral contraceptive drug ‘Leostrin21’
“The approved product has an estimated market size of USD 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 US FDA and 106 products authorised for distribution in the US.
Shares of the company were trading at Rs 770.25 a piece, down 2.03 per cent, from their previous close on the BSE.