Glenmark receives ANDA approval for Norethindrone Acetate, Ethinyl Estradiol Tablets

27 Dec 2017 Evaluate

Glenmark Pharmaceuticals Inc., USA (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 24 Fe Tablets, of Allergan Pharmaceuticals International.

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

Glenmark’s current portfolio consists of 130 products authorized for distribution in the US marketplace and 58 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.


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