Alembic Pharma receives USFDA’s tentative approval for Iloperidone tablets

11 Jul 2018 Evaluate

Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Iloperidone tablets, 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Fanapt Tablets, 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg, of Vanda Pharmaceuticals, Inc. Iloperidone tablets are indicated for the treatment of schizophrenia in adults.

Iloperidone Tablets have an estimated market size of $128 million for twelve months ending December 2017 according to IQVIA.

Alembic now has a total of 74 ANDA approvals (65 final approvals and 9 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

775.30 -13.90 (-1.76%)
16-Jan-2026 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1669.20
Dr. Reddys Lab 1175.55
Cipla 1397.95
Zydus Lifesciences 867.80
Lupin 2176.25
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.

×