Glenmark Pharmaceuticals Limited on Monday announced that it has received final approval by the United States Food & Drug Administration (U.S. FDA) for Nicardipine Hydrochloride Capsules, 20 mg and 30 mg. It is 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., USA, the pharma major stated on Monday.
Nicardipine Hydrochloride Capsules are indicated for to treat severe chest pain (angina) or high blood pressure (hypertension).
According to IQVIATM sales data for the 12-month period ending October 2022, the Cardene Capsules, 20 mg and 30 mg market 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 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.
