Alembic Pharma Receives USFDA Approval for Hypertension Drug Diltiazem Hydrochloride

• Alembic Pharmaceuticals secured USFDA approval for Diltiazem Hydrochloride Extended-Release capsules, a generic alternative to Cardizem CD, used in hypertension treatment.
• The approved capsules will be available in 120 mg to 360 mg dosages, suitable for standalone or adjunctive use in managing hypertension and chronic stable angina.
• The market for Diltiazem Hydrochloride Extended-Release capsules is estimated at $105.3 million for the twelve months ending June 2024, per IQVIA data.
• This approval marks Alembic Pharma's 191st final ANDA approval, strengthening its presence in the U.S. generics market.

Alembic Pharmaceuticals Ltd. announced it has received final approval from the U.S. Food and Drug Administration (USFDA) for its Diltiazem Hydrochloride Extended-Release capsules, a medication used in the treatment of hypertension. The approval allows Alembic to market a generic version of Bausch Health's Cardizem CD in the United States.

The approved Diltiazem Hydrochloride Extended-Release capsules will be available in strengths of 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg. These capsules are indicated for the management of hypertension, and can be used alone or in combination with other antihypertensive agents. Additionally, they are prescribed for the management of chronic stable angina and angina resulting from coronary artery spasms.

According to IQVIA data, the market for Diltiazem Hydrochloride Extended-Release capsules reached an estimated $105.3 million for the twelve-month period ending in June 2024. This approval marks a significant step for Alembic Pharmaceuticals in expanding its U.S. generics portfolio.

With this latest approval, Alembic Pharma now holds 191 final ANDA approvals and 27 tentative approvals from the USFDA, totaling 218 ANDA approvals. The company's manufacturing facilities are approved by regulatory authorities across multiple countries, including the USFDA.