Zydus Lifesciences Gains USFDA Approval for Enzalutamide Capsules, Expands Cancer Treatment Portfolio

Zydus Lifesciences Limited, along with its subsidiaries and affiliates, has received final approval from the U.S. Food and Drug Administration (USFDA) to manufacture Enzalutamide Capsules, 40 mg. 

These capsules, which are used to treat metastatic castration-resistant prostate cancer, work by inhibiting androgen receptors. The capsules will be produced at Zydus’ manufacturing facility in Moraiya, Ahmedabad. In the U.S., Enzalutamide capsules had sales of $869.4 million as of July 2024. Zydus has now received 400 approvals and has filed over 465 Abbreviated New Drug Applications (ANDAs) since it began the process in 2003-04.

In their recent press release on September 27, 2024, Zydus Lifesciences Ltd announced a collaboration with the Central Drug Research Institute (CDRI) to develop new treatments for osteoporosis in chronic kidney disease (CKD) patients. CKD influences over 10% of the global population, leading to a growing loss of kidney function and rising the risk of osteoporosis and fractures, particularly in those over 65, especially women. Conventional anti-osteoporosis medications are often unsafe for CKD patients, creating an urgent need for safer alternatives.

About Zydus Lifesciences Limited

In 1995, the company underwent a restructuring, leading to the formation of Cadila Healthcare under the Zydus group. Starting with a modest turnover of ₹250 crore in 1995, the group saw impressive financial growth, reaching over ₹14,253 crore in FY20. Staying true to its commitment to improving lives, Zydus continues to focus on innovation and meeting healthcare needs. The company also remains dedicated to its mission of building healthier, happier communities worldwide. Zydus is now one of the top five pharmaceutical companies in India.

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