Zydus Lifesciences Secures USFDA Approval for Apalutamide Tablets

Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Apalutamide Tablets, 60 mg. This approval reinforces the company’s presence in the global pharmaceutical industry.

Expanding Oncology Portfolio

Apalutamide is an androgen receptor inhibitor prescribed for patients with metastatic castration-sensitive prostate cancer. The tablets will be manufactured at Zydus Lifesciences Ltd (SEZ), Ahmedabad, strengthening the company’s oncology portfolio.

Market Impact and Regulatory Achievements

The approval comes in a competitive market where Apalutamide tablets recorded annual sales of USD 1,099.8 million in the United States (IQVIA MAT January 2025). With this, Zydus now holds 420 USFDA approvals, reflecting its strong regulatory track record.

Zydus Lifesciences Share Performance 

As of March 19, 2025, at 12:10 PM, the shares of Zydus Lifesciences share price are trading at ₹911.85 per share, reflecting a profit of 1.08 from the previous day’s closing price. Over the past month, the stock has registered a surge of 2.29%.

Conclusion

This milestone further cements Zydus’ position in the pharmaceutical sector, ensuring the availability of high-quality treatment options for cancer patients while expanding its global footprint.

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