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Zydus Life gets final approval from USFDA for cancer drug

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Zydus Lifesciences announced that it has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Enzalutamide Capsules, 40 mg.

The Enzalutamide capsules are androgen receptor inhibitors indicated for the treatment of patients with metastatic castration-resistant prostate cancer.

The drug will be manufactured at the groups formulation manufacturing facility in Moraiya, Ahmedabad.

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According to IQVIA MAT July 2024, Enzalutamide capsules, 40 mg, generated annual sales of $869.4 million in the United States.

With this approval, the group now holds a total of 400 approvals and has filed over 465 abbreviated new drug applications (ANDAs) since the filing process began in FY 2003-04.

 

Zydus Lifesciences is a discovery-driven, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.

The pharma companys consolidated net profit surged 30.64% to Rs 1,419.9 crore in Q1 FY25 as compared to Rs 1,086.9 crore posted in Q1 FY24. Revenue from operations jumped 20.77% year on year (YoY) to Rs 6,207.5 crore in the quarter ended 30 June 2024.

Shares of Zydus Lifesciences rose 0.59% to end at Rs 1,074.60 on Friday, 27 September 2024.

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First Published: Sep 28 2024 | 2:42 PM IST

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