Alembic Pharma gets USFDA’s nod for Tadalafil Tablets

27 Mar 2019 Evaluate

Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Tadalafil Tablets USP, 2.5 mg, 5 mg, 10-mg and 20 mg. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Cialis Tablets, 2.5 mg, 5 mg, 10 mg, and 20 mg, of Eli Lilly and Company (Lilly). All strengths of Tadalafil Tablets are indicated for the treatment of erectile dysfunction (ED).

Tadalafil Tablet 5mg strength is additionally indicated for treatment of signs and symptoms of benign prostatic hyperplasia (BPH). Alembic had previously received tentative approval for this ANDA. Tadalafil Tablets have an estimated market size of $1.8 billion for twelve months ending December 2018 according to IQVIA.

Alembic now has a total of 89 ANDA approvals (77 final approvals and 12 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

1036.30 -8.30 (-0.79%)
24-Dec-2024 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1817.60
Dr. Reddys Lab 1351.25
Cipla 1475.90
Lupin 2168.30
Zydus Lifesciences 964.40
View more..
© 2024 The Alchemists Ark Pvt. Ltd. All rights reserved. MoneyWorks4Me ® is a registered trademark of The Alchemists Ark Pvt. Ltd.