Glenmark  receives ANDA approval for Norethindrone Acetate and Ethinyl Estradiol Tablets USP

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Mumbai : Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) 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 Limited.

According to IQVIATM sales data for the 12 month period ending October 2017, the Minastrin 1 24 Fe Tablets market2 achieved annual sales of approximately $337.0 million. Glenmark’s current portfolio consists of 130 products authorized for distribution in the U.S. marketplace and 58 ANDA’s pending approval with the U.S. FDA. 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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