USFDA approves Zydus Lifesciences' prostate cancer injection

Drugmaker Zydus Lifesciences Ltd. has received final approval from the United States Food and Drug Administration (USFDA) for its Leuprolide Acetate injection, the company announced on Friday, November

14.

The Leuprolide Acetate injection, used for the palliative treatment of advanced prostatic cancer, will be manufactured at the company's oncology injectable facility in Special Economic Zone-1, Ahmedabad.

This approval allows Zydus Lifesciences to enter the promising US market, where Leuprolide Acetate injection generates $69 million in annual sales, the company said.

With this, the company has secured 427 approvals, with applications filed for 487 generic drugs to be sold in the US as of September 30, 2025.

This includes the USFDA approval for a generic version of Vumerity, which the company announced the previous day. Zydus Lifesciences informed the exchanges on Thursday, November 13, that the USFDA cleared Diroximel Fumarate delayed-release capsules (231 mg), a drug used to treat relapsing forms of multiple sclerosis (MS) in adults.

The string of approvals follows the USFDA’s pre-approval inspection of its SEZ-1 manufacturing site in Ahmedabad, conducted between November 4 and 13, 2025.

The approvals could also boost the company's business performance in the coming months. Healthy business momentum across geographies helped Zydus deliver strong earnings in Q2 of the current financial year.

Net profit rose 39% year-on-year to ₹1,259 crore from ₹911 crore in the same period last year. Revenue for the quarter climbed 17% year-on-year to ₹6,123 crore, driven by strong performance in the company’s US and India formulations businesses.

The company recorded a foreign exchange gain of ₹414 crore, compared with ₹45 crore in the previous year.

Shares of Zydus Lifesciences are trading at ₹942.45, just 0.18% below the day's opening on the NSE.