Alembic Pharmaceuticals Limited has announced that it 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 prescribed for managing hypertension, either alone or with other antihypertensive agents, and for the treatment of chronic stable angina and angina resulting from coronary artery spasms.
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.
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.
About Alembic Pharmaceuticals Limited
Alembic Pharmaceuticals, a research-oriented company established in 1907, is a leader in branded generics in India. Headquartered in India, Alembic produces and distributes generic pharmaceutical products worldwide. The company’s research and manufacturing facilities are accredited by major regulatory bodies, including the USFDA, and it has a strong presence in the Indian healthcare market through a field force of over 5,200 representatives.
Disclaimer: The information provided is for informational purposes only and should not be considered as financial or investment advice.
