Zydus Lifesciences Limited 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 Acetates injections will be manufactured at the Company's oncology injectable manufacturing facility at SEZ1, Ahmedabad ('ALIDAC'). Leuprolide Acetated injection had annual sales of USD 69 mn in the United States (IQVIA MAT Sept-2025).
The group now has 427 approvals and has so far filed 487 ANDAs since the commencement of the filing process in fiscal year 2003-04.
