Alembic Pharma gets USFDA approval hypertension drug

11 Nov 2024 , 12:54 PM

Alembic Pharmaceuticals stated that it gained final FDA approval for the Diltiazem Hydrochloride Extended-Release capsules, which are used to treat hypertension.

Alembic Pharma reported in a stock exchange filing that these capsules will be available in dosages of 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg, giving a generic alternative to Bausch Health’s brand-name Cardizem CD capsules sold in the United States.

Diltiazem Hydrochloride Extended-Release Capsules are licensed to treat hypertension and can be used alone or in conjunction with other antihypertensive medications. 

These medications are also used to treat chronic stable angina and angina induced by coronary artery spasm.

According to the most recent IQVIA statistics, the market for Diltiazem Hydrochloride Extended-Release Capsules in these dosages is expected to be roughly $105.3 million in the 12 months ending June 2024.

Alembic Pharma’s latest approval strengthens its position in the generics industry in the United States. The company stated that it now has 218 ANDA approvals from the USFDA. This includes 191 final and 27 tentative approvals.

Last month, Alembic Pharma announced that the USFDA concluded its inspection of the cancer formulation facility in Panelav, Gujarat, with no observations. The company said that the USFDA inspected the plant on October 7 and 8.

Alembic Pharmaceuticals, founded in 1907, is well-known for its vast R&D skills. The company, headquartered in India, operates cutting-edge production facilities that have been licensed by regulatory bodies in several countries, including the United States Food and Drug Administration.

Alembic, in addition to its expanding generics portfolio in the United States, is a market leader in branded generics in India, with a field force of over 5,200 specialists.

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