Alembic Pharmaceuticals Receives USFDA Approval for Diltiazem Hydrochloride Tablets

17 Nov 2025 , 09:04 AM

Alembic Pharmaceuticals said on November 15 that it has secured final approval from the US Food and Drug Administration. The approval is granted for one of its important generic filings. The approval is for Diltiazem Hydrochloride Tablets USP. This will be available in four strengths: 30 mg, 60 mg, 90 mg and 120 mg. This medicine is commonly prescribed to manage high blood pressure and different forms of angina, including chronic stable angina and angina linked to coronary artery spasms. Alembic’s version has been cleared as therapeutically equivalent to Cardizem Tablets, the reference drug marketed by Bausch Health US LLC.

With this clearance added to its portfolio, Alembic now holds 230 approvals for its ANDA submissions with the US regulator, out of which 210 are final approvals and 20 are tentative approvals. The company said this development further strengthens its US generics business and adds depth to its offerings in the cardiovascular segment.

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