Zydus Secures USFDA Nod for Leuprolide Acetate Injection

Zydus Lifesciences has received the final approval from the USFDA to market Leuprolide Acetate injection through a 14 mg/2.8 mL multiple-dose vial (1 mg/0.2 mL).

This is the generic product of Lupron Injection which is used in the palliative treatment of patients with advanced prostate cancer.

The drug will be manufactured in Zydus’s dedicated oncology injectable plant at SEZ-1, Ahmedabad (ALIDAC), underlining its commitment to building complex injectable capabilities.

According to IQVIA MAT data for September 2025, the reference Leuprolide Acetate injection generated around USD 69 million in annual US sales, pointing to a solid market opportunity for the generic.

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From an industry perspective, this approval adds meaningful strength to Zydus’s US oncology portfolio. It demonstrates the company’s growing ability to deliver complex generics in regulated markets — not just small-molecule drugs, but also specialized injectables. Producing a palliative cancer therapy like Leuprolide Acetate locally at its Ahmedabad site brings cost leverage and scale advantages, which could make the treatment more accessible.

For the overall pharmaceutical market, this approval from Zydus reflects that Indian firms are becoming greater competitors in high-barrier, high-impact therapy areas. The approval allows Zydus to enhance its prostate cancer treatment offerings and demonstrates the company’s commitment to its long-term vision: creating a differentiated and regulated-market, specialty and oncology-led business.