Glenmark receives ANDA approval for Norethindrone Acetate and Ethinyl Estradiol Caps
The company has also received approval for Ferrous Fumarate Capsules, 1 mg/20 mcg
Glenmark Pharmaceuticals has received final approval by the United States Food & Drug Administration (US FDA) for Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules, 1 mg/20 mcg, the generic version of Taytulla1 Capsules, of Allergan Pharmaceuticals International.
According to IQVIATM sales data for the 12 months ending May 2022, the Taytulla Capsules market achieved annual sales of approximately $85.9 million.
Glenmark’s current portfolio consists of 177 products authorised for distribution in the US marketplace and 47 ANDA’s pending approval with the US 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.