Alembic Pharmaceuticals Gains USFDA Approval for Diltiazem Tablets

Alembic Pharmaceuticals Limited has announced the receipt of final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Diltiazem Hydrochloride Tablets USP. The approved strengths are 30 mg, 60 mg, 90 mg, and 120 mg. These tablets are therapeutically equivalent to the reference listed drug, Cardizem Tablets, manufactured by Bausch Health US, LLC.

The Diltiazem Hydrochloride Tablets are indicated for the management of chronic stable angina and angina due to coronary artery spasm. The approval of this ANDA is a part of Alembic’s ongoing efforts to expand its portfolio of generic pharmaceutical products in the United States.

With this latest approval, Alembic Pharmaceuticals now has a cumulative total of 230 ANDA approvals from the USFDA. This total includes 210 final approvals and 20 tentative approvals, reflecting the company’s commitment to providing a wide range of generic medications.

Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company. It focuses on manufacturing and marketing generic pharmaceutical products globally. The company has been a part of the healthcare industry since 1907 and is recognized for its state-of-the-art research and manufacturing facilities, which are approved by regulatory authorities in many developed countries, including the USFDA. Alembic is also a leader in branded generics in India, with a significant presence in the market.