Glenmark receives ANDA approval for Nicardipine Hydrochloride capsules

Mumbai: Glenmark Pharmaceuticals Limited (Glenmark) has received final approval from the United States Food & Drug Administration (U S FDA) for Nicardipine Hydrochloride Capsules, 20 mg and 30 mg, the generic version of Cardene® Capsules, 20 mg and 30 mg, of Chiesi USA, Inc. Glenmark’s Nicardipine Hydrochloride Capsules, 20 mg and 30 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals Inc.

According to IQVIATM sales data for the 12-month period ending October 2022, the Cardene capsules, 20 mg and 30 mg achieved annual sales of approximately $10.9 million.

Glenmark’s current portfolio consists of 178 products authorized for distribution in the U.S. marketplace and 46 ANDA's pending approval from the U.S. FDA.