Zydus gets USFDA nod for key prostate cancer drug

Business Nov 15, 2025

Zydus Lifesciences just scored final approval from the USFDA for its Leuprolide Acetate injection, used to help treat advanced prostate cancer.
The drug will be made in Ahmedabad and is set to enter a US market worth $69 million a year—giving Zydus a solid boost in the global pharma game.

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This win is part of Zydus's bigger push in the US, where they've now racked up 427 FDA approvals and filed 487 generic drug applications as of September 2025.
They recently got another green light for a multiple sclerosis treatment too.
On top of that, Zydus reported strong financials last quarter, with profits jumping 39% and revenue up 17%, thanks to good runs in both the US and India plus some helpful currency gains.