Zydus Lifesciences has received final approval from the USFDA for Leuprolide Acetate injection, 14 mg/2.8 mL (1 mg/0.2 mL) multiple-dose vial. This injection is indicated for the palliative treatment of advanced prostatic cancer and will be manufactured at the company’s oncology injectable manufacturing facility in Ahmedabad. The annual sales for Leuprolide Acetate injection were USD 69 million in the United States.
USFDA Approval Received
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. This approval allows Zydus to manufacture and market this product in the United States.
Indication and Manufacturing
The Leuprolide Acetate injection is indicated for use in the palliative treatment of advanced prostatic cancer. It will be manufactured at Zydus’s oncology injectable manufacturing facility at SEZ1, Ahmedabad.
Market Opportunity
According to IQVIA data from September 2025, the annual sales for Leuprolide Acetate injection in the United States were USD 69 million. This approval provides Zydus with an opportunity to tap into this market.
Zydus’s ANDA Filings
As of September 30, 2025, the group has 427 approvals and has filed 487 ANDAs since the commencement of the filing process in FY 2003-04.
Source: BSE
