Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Leuprolide Acetate injection, 14 mg/2.8 mL (1 mg/0.2 mL) multiple-dose vial (USRLD: Lupron Injection, 1 mg/0.2 mL). Leuprolide Acetate injection is indicated in the palliative treatment of advanced prostatic cancer. Leuprolide Acetate injections will be manufactured at the company’s oncology injectable manufacturing facility at SEZ1, Ahmedabad (‘ALIDAC’). 

Leuprolide Acetate injection had annual sales of $69 million in the United States (IQVIA MAT September 2025). The group now has 427 approvals and has so far filed 487 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences (formerly known as Cadila Healthcare), a company limited by shares, incorporated and domiciled in India, operates as an integrated pharmaceutical company with business encompassing the entire value chain in the research, development, production, marketing and distribution of pharmaceutical products.