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Thursday, January 21, 2016

Glenmark gets USFDA nod for Norethindrone Acetate, Ethinyl Estradiol tablets

Pharma giant, Glenmark Pharmaceuticals said that Glenmark Pharmaceuticals Inc., USA (Glenmark) has received United States Food & Drug Administration (USFDA) approval for Norethindrone Acetate and Ethinyl Estradiol Tablets. Norethindrone Acetate and Ethinyl Estradiol Tablets are the generic version of Loestrin 21 1/20 Tablets of Warner Chilcott Company, LLC, the company said in a filing to the Bombay Stock Exchange. According to IMS Health sales data for the 12-month period ending November 2015, the Loestrin 21 1/20 Tablets market achieved annual sales of approximately USD 56.8 million. Glenmark’s current portfolio consists of 106 products authorized for distribution in the US marketplace and 62 ANDA’s pending approval with the USFDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio. Meanwhile, shares of the company were trading at Rs 767 apiece, down 2.45 per cent from the previous close at 12:06 hours on BSE.