Alembic Pharmaceutical announced on Monday, 11 November, that they had received approval from the US Food and Drug Administration (USFDA) for the Diltiazem Hydrochloride Extended-Release capsules that are used for treating hypertension. 

The Diltiazem Hydrochloride Extended-Release capsules are available in dosages of 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg and offer a generic alternative to Cardizem CD capsules of Bausch Health in the United States. 

The Diltiazem Hydrochloride Extended-Release capsules are used for managing hypertension and are suitable for use either as a standalone treatment or in conjunction with other antihypertensive medications. 

These capsules are also prescribed for managing chronic stable angina and angina caused by coronary artery spasms. 

According to recent IQVIA data, the market for Diltiazem Hydrochloride Extended-Release Capsules in these dosages is valued at approximately $105.3 million for the twelve months ending in June 2024.

This latest approval has further bolstered Alembic Pharma’s standing in the US generics market, bringing its cumulative ANDA approvals from the USFDA to 218, which includes 191 final approvals and 27 tentative ones.

In addition, last month, Alembic Pharma reported that the USFDA completed an inspection of its oncology formulation facility in Panelav, Gujarat, on October 7 and 8 without any observations, underscoring the facility’s compliance.

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