Zydus Lifesciences gets USFDA’s tentative approval for Enzalutamide Tablets

03 Oct 2024 Evaluate

Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration (USFDA) to manufacture Enzalutamide Tablets, 40 mg and 80 mg (USRLD: Xtandi Tablets, 40 mg, 80 mg). Enzalutamide tablets are androgen receptor inhibitors indicated for the treatment of patients with castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer. 

Enzalutamide Tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad. Enzalutamide tablets, 40 mg and 80 mg had annual sales of $1417.2 million in the United States (IQVIA MAT July 2024). The group now has 400 approvals and has so far filed over 465 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.


Zydus Lifesciences Share Price

881.95 -2.90 (-0.33%)
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.

×