Alembic Pharmaceuticals receives USFDA approval for Amantadine Hydrochloride Capsules

22 Jun 2017 Evaluate

Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Amantadine Hydrochloride Capsules, USP, 100mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Symmetrel Capsules, 100mg, of Endo Pharmaceuticals Inc. Amantadine Hydrochloride Capsules have an estimated market size of $37 million for twelve months ending December 2016, according to IMS.

Amantadine Hydrochloride Capsules, USP are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine Hydrochloride Capsules, USP are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Alembic now has a total of 58 ANDA approvals (52 final approvals and 6 tentative approvals) from USFDA.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907. The company manufactures and markets generic pharmaceuticals products all over the world.


Alembic Pharma Share Price

762.55 -6.00 (-0.78%)
23-Jan-2026 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1631.65
Dr. Reddys Lab 1235.15
Cipla 1314.85
Zydus Lifesciences 881.95
Lupin 2137.15
View more..
Register Now to get our Free Newsletter & much more!

© 2026 The Alchemists Ark Pvt. Ltd. All rights reserved. MoneyWorks4Me ® is a registered trademark of The Alchemists Ark Pvt. Ltd.

×