Alembic Pharma gets US FDA approval for angina treatment drug Diltiazem

Alembic Pharmaceuticals said that it has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Diltiazem Hydrochloride Tablets USP.

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Cardizem Tablets of Bausch Health US, LLC.

Diltiazem hydrochloride tablets are indicated for the management of chronic stable angina and angina due to coronary artery spasm.

Alembic has a cumulative total of 230 ANDA approvals (210 final approvals and 20 tentative approvals) from USFDA.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world. Its research and manufacturing facilities are approved by regulatory authorities of many developed countries, including the USFDA.

The companys consolidated net profit jumped 20.40% to Rs 184.71 crore in Q2 FY26, compared to Rs 153.41 crore posted in Q2 FY25. Revenue from operations grew 15.90% year on year (YoY) to Rs 1,910.15 crore in the quarter ended 30 September 2025.

The scrip had fallen 1.58% to end at Rs 902.80 on the BSE yesterday.

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