Alembic Pharma gets USFDA nod for hypertension treatment drug

Alembic Pharmaceuticals Ltd on Monday, November 11, said it has received final approval from the US Food and Drug Administration (USFDA) for the Diltiazem Hydrochloride Extended-Release capsules, used for treating hypertension.

These capsules will be available in dosages of 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg, offering a generic alternative to the brand-name Cardizem CD capsules marketed by Bausch Health in the United States, Alembic Pharma said in a stock exchange filing.

Diltiazem Hydrochloride Extended-Release capsules are indicated for managing hypertension and are suitable for use either as a standalone treatment or in conjunction with other antihypertensive medications. These are also prescribed for managing chronic stable angina and angina caused by coronary artery spasms.

According to the latest IQVIA data, the market for Diltiazem Hydrochloride Extended-Release Capsules in these dosages is estimated to be around $105.3 million for the twelve months ending June 2024.

With this latest approval, Alembic Pharma has further strengthened its presence in the U.S. generics market. The company now holds a cumulative total of 218 ANDA approvals from the USFDA, comprising 191 final approvals and 27 tentative approvals.

Last month, Alembic Pharma announced that the USFDA completed its inspection of the oncology formulation facility in Panelav, Gujarat, without any observations. The inspection of the facility was conducted on October 7 and 8 by the USFDA.

Founded in 1907 Alembic Pharmaceuticals is known for its extensive research and development capabilities. The company, headquartered in India, operates state-of-the-art manufacturing facilities approved by regulatory authorities across multiple countries, including the USFDA.

Beyond its growing U.S. generics portfolio, Alembic is a leader in branded generics in India, supported by a field force of over 5,200 professionals.

Opening higher at ₹1039.00, shares of Alembic Pharma gained 2.4% to touch an intraday high of ₹1064.15 apiece on the BSE. The stock, however, trimmed the early gain and was seen trading 2.01% lower at ₹1018.15 apiece at around 10 am on Monday.

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