Alembic Pharmaceuticals Limited, a vertically integrated, R&D-driven pharmaceutical company, has received final approval from the US Food & Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for diltiazem hydrochloride tablets USP in strengths of 30 mg, 60 mg, 90 mg, and 120 mg.
The product has been deemed therapeutically equivalent to the reference listed drug (RLD), Cardizem tablets (30 mg, 60 mg, 90 mg, and 120 mg), marketed by Bausch Health US, LLC. Diltiazem hydrochloride tablets are prescribed for the management of chronic stable angina and angina arising from coronary artery spasm.
With this approval, Alembic now holds a cumulative total of 230 ANDA approvals from the USFDA, comprising 210 final approvals and 20 tentative approvals.
Established in 1907 and headquartered in India, Alembic Pharmaceuticals is a publicly listed global manufacturer and marketer of generic pharmaceutical products, recognized for its sustained focus on research, innovation, and high-quality healthcare solutions.
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