Glenmark gets ANDA approval for Norethindrone Acetate and Ethinyl Estradiol Tablets USP and Ferrous Fumarate Tablets, 1 mg/20 mcg

Glenmark’s current portfolio consists of 130 products authorised for distribution in the US Marketplace and 58 ANDAs pending approval with the USFDA
Glenmark Pharmaceuticals Inc, US (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Norethindrone Acetate and Ethinyl Estradiol Tablets USP and Ferrous Fumarate Tablets, 1 mg/20 mcg, the generic version of Minastrin 1 24 Fe Tablets, of Allergan Pharmaceuticals International.

According to IQVIATM sales data for the 12 month period ending October 2017, the Minastrin 1 24 Fe Tablets market achieved annual sales of approximately $337.0 million.

Glenmark’s current portfolio consists of 130 products authorised for distribution in the US Marketplace and 58 ANDAs 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.