Zydus Lifesciences Limited has recently informed exchanges that the company has received tentative approval from the United States Food and Drug Administration (USFDA) to manufacture Enzalutamide Tablets, 40 mg and 80 mg.
Enzalutamide tablets are androgen receptor inhibitors used for the treatment of patients with castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer. Enzalutamide Tablets will be manufactured in the Group’s SEZ site in Ahmedabad.
Enzalutamide tablets, 40 mg and 80 mg have annual sales of USD 1417.2 million in the United States (IQVIA MAT July 2024).
The group currently has 400 approvals and has submitted over 465* ANDAs since the filing procedure began in FY 2003-04.
