Zydus Lifesciences gets USFDA approval for apalutamide tablets

19 Mar 2025 , 11:30 AM

Zydus Lifesciences Limited announced on Tuesday that it has secured the final approval from the United States Food and Drug Administration (USFDA) for manufacturing and marketing apalutamide tablets, 60 mg. As per the drugmaker, the said drug is a generic equivalent of Erleada tablets, 60 mg.
Apalutamide is an androgen receptor inhibitor to be used for the treatment of patients with metastatic castration-sensitive prostate cancer. Zydus Lifesciences shall produce the Apalutamide tablets at its facility situated in Ahmedabad.
As per the IQVIA MAT January 2025 data, apalutamide tablets registered annual sales of $1099.80 million in the United States markets.
Zydus Lifesciences Group so far has filed 483 ANDAs and holds 420 approvals since the commencement of the filing process in FY 2003-04.
The company reported a net profit of ₹1,023 Crore in the quarter ended December 2024. The surge in profitability was supported by an increase in its forex gain. In the previous corresponding quarter, the company reported a net profit of ₹789 Crore.
The company’s revenue from operations registered a growth of 17% in Q3FY25 at ₹5,269 Crore.
During the quarter under review, US formulation sales for the company stood at $285 million, registering a growth of 29% on a year-on-year basis. The US markets contribute about 47% to Zydus Life’s overall revenue.
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