Glenmark gets US FDA approval for Nicardipine Hydrochloride capsules

Glenmark Pharmaceuticals said that it has received final approval by the United States Food & Drug Administration (US FDA) for Nicardipine Hydrochloride Capsules, 20 mg and 30 mg.

The approved abbreviated new drug application (ANDA) is a generic version of Cardene Capsules, 20 mg and 30 mg, of Chiesi USA, Inc.

Glenmark's Nicardipine Hydrochloride Capsules will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA.

Nicardipine (Cardene) is a medication used to treat high blood pressure and angina. It is also used for Raynaud's phenomenon.

According to IQVIA sales data for the 12-month period ending October 2022, the Cardene Capsules 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 said in a statement.

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

The company's consolidated net profit rose 1.1% to Rs 260.44 crore on a 6% increase in net sales to Rs 3,312.49 crore in Q2 FY23 over Q2 FY22.

The scrip shed 0.12% to currently trade at Rs 417.20 on the BSE.

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