Glenmark Pharma gets ANDA approval for generic birth control drug

Glenmark Pharmaceuticals Inc., USA has received final approval by the United States Food & Drug Administration (USFDA) for Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules, 1 mg/20 mcg.

The approved drug is the generic version of Taytulla Capsules, of Allergan Pharmaceuticals International.

The drug is a prescription birth control pill used for the prevention of pregnancy.

According to IQVIA sales data for the 12 month period ending May 2022, the Taytulla Capsules market achieved annual sales of approximately $85.9 million.

Glenmark's current portfolio consists of 177 products authorized for distribution in the U.S. marketplace and 47 ANDA's pending approval with the U.S. FDA.

Glenmark Pharmaceuticals is a global pharmaceutical company with a presence across specialty, generics, and OTC businesses.

The pharma company's consolidated net profit slumped 33.5% to Rs 155.59 crore on a 4.6% rise in net sales to Rs 2,961.15 crore in Q4 FY22 over Q4 FY21.

The scrip advanced 0.86% to settle at Rs 379.90 on Thursday, 28 July 2022.

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