Glenmark Pharma gets ANDA approval for HAILEY Fe 1/20 tablets

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Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for HAILEY Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/20 mcg and Ferrous Fumarate Tablets), the generic version of Loestrin1 Fe 1/20 Tablets, of Allergan Pharmaceuticals International Limited.

Glenmark’s current portfolio consists of 129 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.