Alembic Pharma receives USFDA approval for Candesartan Cilexetil tablets

05 Dec 2018 Evaluate

Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Candesartan Cilexetil tablets USP, 4 mg, 8 mg, and 16 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Atacand Tablets, 4 mg, 8 mg, and 16 mg, of ANI Pharmaceuticals, Inc. Candesartan cilexetil tablets are indicated for the treatment of hypertension in adults and in children 1 to less than 17 years of age, to lower blood pressure. Candesartan cilexetil tablets also indicated for the treatment of heart failure.

Candesartan Cilexetil Tablets USP, 4 mg, 8 mg, and 16 mg, have an estimated market size of $22 million for twelve months ending December 2017 according to IQVIA. The company has a cumulative total of 82 ANDA approvals (69 final approvals and 13 tentative approvals) from USFDA.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.

Alembic Pharma Share Price

899.90 -2.30 (-0.25%)
05-Dec-2025 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1804.95
Dr. Reddys Lab 1275.05
Cipla 1520.55
Zydus Lifesciences 931.45
Lupin 2097.65
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.

×