Glenmark Pharma bags USFDA nod for high BP drug Nicardipine Hydrochloride

Mumbai: Drugmaker, Glenmark Pharmaceuticals Limited, has announced that the company has received final approval from the United States Food & Drug Administration (USFDA) for Nicardipine Hydrochloride Capsules, 20 mg, and 30 mg.

The product 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.

Nicardipine is used alone or together with other medicines to treat severe chest pain or high blood pressure.

According to IQVIA 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," the company stated.

Medical Dialogues had earlier reported that Glenmark Pharmaceuticals Inc., USA had received final approval from the USFDA for Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP, 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg indicated for the treatment of hypertension.

Read also: Glenmark bags USFDA nod for generic version of Ziac Tablets

Glenmark Pharmaceuticals Ltd. is an innovation-driven global pharmaceutical company with a presence across Specialty, Generics, and OTC businesses. It focuses on the key therapeutic areas of respiratory, dermatology, and oncology. The company has 10 world-class manufacturing facilities spread across 4 continents and operations in over 80 countries. The company was listed on the Dow Jones Sustainability Index (DJSI), one of the world's most respected and widely accepted sustainability benchmarks, under the category of emerging markets (2021) for the fourth consecutive year.