Alembic Pharmaceuticals Limited has received final approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Diltiazem Hydrochloride Extended-Release Capsules USP in strengths of 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg. This approval confirms the therapeutic equivalence of Alembic’s product to the reference drug, Cardizem CD Extended-Release Capsules, by Bausch Health US, LLC.
Diltiazem Hydrochloride Extended-Release Capsules are indicated for the management of hypertension, either alone or with other antihypertensive agents. It is also used in the treatment of chronic stable angina and angina resulting from coronary artery spasms. The approval allows Alembic to manufacture and market this generic version, providing a cost-effective alternative for patients.
According to IQVIA, the market size for Diltiazem Hydrochloride Extended-Release Capsules is estimated at $105.3 million for the twelve months ending June 2024. This indicates a substantial market opportunity for Alembic Pharmaceuticals.
With this approval, Alembic Pharmaceuticals has now achieved a cumulative total of 218 ANDA approvals, including 191 final approvals and 27 tentative approvals from the USFDA. This milestone reflects the company's robust regulatory capabilities and commitment to expanding its product portfolio in the US market.
About Diltiazem Hydrochloride
Diltiazem Hydrochloride is a calcium channel blocker used to treat hypertension and certain heart conditions. It works by relaxing blood vessels, which allows blood to flow more easily and reduces blood pressure. It is commonly prescribed for patients with hypertension, chronic stable angina, and angina resulting from coronary artery spasms.
Alembic Pharmaceuticals: A Brief Overview
Alembic Pharmaceuticals Limited, established in 1907, is a research-oriented pharmaceutical company based in India. It focuses on developing and manufacturing generic pharmaceutical products, which are distributed worldwide. The company's research and manufacturing facilities are accredited by major regulatory bodies, including the USFDA. Alembic has a strong presence in the Indian healthcare market, supported by a large field force.
