Zydus Lifesciences Ltd saw nearly 3% surge in its stock price after securing final approval from the U.S. Food and Drug Administration (USFDA) to manufacture and market Apalutamide Tablets, 60 mg, in the U.S. market.
Apalutamide, an androgen receptor inhibitor, is used for treating metastatic castration-sensitive prostate cancer (mCSPC). The approved drug will be produced at Zydus’ SEZ facility in Ahmedabad, strengthening the company’s presence in the U.S. generics market.
According to IQVIA MAT January 2025 data, the annual U.S. sales of Apalutamide tablets stood at $1,099.8 million, highlighting a lucrative opportunity for Zydus. The approval allows the company to tap into a high-demand segment, reinforcing its position as a key generic pharmaceutical player.
With this latest approval, Zydus Lifesciences now boasts 420 approvals and has filed 483 Abbreviated New Drug Applications (ANDAs) since FY 2003-04. This milestone aligns with the company’s strategy of expanding its product portfolio and enhancing access to affordable, high-quality generics worldwide.
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