Alembic Pharmaceuticals gets USFDA’s tentative approval for Vortioxetine Tablets

07 Jan 2022 Evaluate

Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Vortioxetine Tablets 5 mg, 10 mg, 15 mg, and 20 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Trintellix Tablets 5 mg, 10 mg, 15 mg, and 20 mg, of Takeda Pharmaceuticals, USA, lnc.. (Takeda).

Vortioxetine Tablets are indicated for the treatment of major depressive disorder (MOD). Vortioxetine Tablets 5 mg, 10 mg, 15 mg, and 20 mg have an estimated market size of $ 1249 million for twelve months ending September 2021 according to IQVIA. Alembic has received year to date (YTD) 18 approvals (13 final approvals and 5 tentative approvals) and a cumulative total of 157 ANDA approvals (136 final approvals and 21 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.

×