Zydus Lifesciences has strengthened its US oncology portfolio with a fresh approval from the United States Food and Drug Administration for Leuprolide Acetate Injection, 14 mg/2.8 mL, supplied as a multiple-dose vial. The product is the approved generic equivalent of Lupron Injection (1 mg/0.2 mL), a widely used therapy in the palliative treatment of advanced prostate cancer.
The company will manufacture the newly approved injection at its dedicated oncology injectable facility in SEZ1, Ahmedabad, known as ALIDAC. This facility has been central to Zydus’ expansion in complex formulations and regulated market supplies.
Leuprolide Acetate continues to hold a steady position in the US market with annual sales of around USD 69 million, according to IQVIA MAT September 2025 data. The approval is therefore expected to support Zydus’ US revenue stream and reinforce its presence in a category where consistent demand and clinical relevance remain strong.
This latest clearance takes Zydus Lifesciences to 427 approvals in the US market. Since initiating its ANDA filing programme in FY 2003–04, the group has submitted 487 applications, reflecting a sustained focus on developing differentiated products, especially in oncology and other high-value therapeutic areas.
