Alembic Pharmaceuticals gets USFDA’s final nod for Diltiazem Hydrochloride Tablets

15 Nov 2025 Evaluate

Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Diltiazem Hydrochloride Tablets USP, 30 mg, 60 mg, 90 mg, and 120 mg. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Cardizem Tablets, 30 mg, 60 mg, 90 mg, and 120 mg, of Bausch Health US, LLC. 

Diltiazem hydrochloride tablets are indicated for the management of chronic stable angina and angina due to coronary artery spasm. The company has a cumulative total of 230 ANDA approvals (210 final approvals and 20 tentative approvals) from USFDA.

Alembic Pharmaceuticals (Alembic Pharma) is involved in manufacturing and marketing of India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities.


Alembic Pharma Share Price

900.00 -2.20 (-0.24%)
05-Dec-2025 12:26 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1808.90
Dr. Reddys Lab 1280.20
Cipla 1521.35
Zydus Lifesciences 933.70
Lupin 2100.00
View more..
Register Now to get our Free Newsletter & much more!

© 2025 The Alchemists Ark Pvt. Ltd. All rights reserved. MoneyWorks4Me ® is a registered trademark of The Alchemists Ark Pvt. Ltd.

×