Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to produce and sell Apalutamide tablets (60 mg) in the U.S. Apalutamide is a medicine used to treat prostate cancer that has spread but is still responsive to hormone therapy.

The tablets will be made at Zydus Lifesciences’ Special Economic Zone (SEZ) facility in Ahmedabad. As per IQVIA MAT data from January 2025, Apalutamide tablets generated sales of around $1.1 billion in the U.S.

Growing Portfolio and Achievements

With this approval, Zydus Lifesciences now has 420 approved medicines and has submitted 483 applications to the USFDA since it started filing in 2003-04. This milestone further strengthens the company’s position in the global pharmaceutical industry, particularly in generic and specialty drugs.

Strong Financial Growth

Zydus Lifesciences, a global healthcare company focused on innovation, reported a solid financial performance in Q3 FY25. The company’s net profit jumped 29.62% year-on-year (YoY) to ₹1,023.5 crore, up from ₹789.6 crore in Q3 FY24. Revenue from operations also increased 16.96% YoY, reaching ₹5,269.1 crore during the quarter.

Following the USFDA approval news, Zydus Lifesciences’ stock price rose 0.57% to ₹908.25 on the Bombay Stock Exchange (BSE), reflecting investor confidence in its growth and regulatory success.

Zydus Lifesciences continues to expand its presence in the global pharmaceutical market. This latest USFDA approval reinforces the company’s commitment to delivering affordable and effective healthcare solutions worldwide.