Zydus Lifesciences Receives USFDA Clearance for Leuprolide Acetate Injection

Zydus Lifesciences has received final approval from the US Food and Drug Administration (USFDA) for its Leuprolide Acetate injection (14 mg/2.8 mL; 1 mg/0.2 mL), a key oncology product used in the palliative management of advanced prostate cancer.  

The approval marks another milestone in the company’s long-standing focus on expanding its regulated-market portfolio. 

Key Development: USFDA Approval for Oncology Injectable 

The approved Leuprolide Acetate formulation corresponds to the reference listed drug Lupron Injection and will be produced at Zydus’ dedicated oncology injectables facility at SEZ-I in Ahmedabad.  

The product addresses a critical therapeutic area and strengthens the company’s pipeline in the US, where the molecule clocked annual sales of $69 million as of IQVIA MAT September 2025. With this clearance, Zydus continues to build scale in specialised, high-value treatments. 

Broader Portfolio Insight: Growing ANDA Footprint 

The final approval pushes Zydus’ cumulative tally to 427 regulatory approvals from the USFDA, with 487 ANDA filings since the company began its submissions in FY 2003–04. The consistent pace of filings highlights the group’s focus on complex generics and oncology-led therapies, positioning it strongly for future launches across the US generics market. 

Read More: Best Pharma Stocks in November 2025 - Neuland Labs, Wockhardt & More – 5yr CAGR Basis! 

Zydus Lifesciences Share Performance 

As of November 14, 2025, Zydus Lifesciences share price is closed at ₹944.50 per share, reflecting a surge of 0.037% from the previous closing price. 

Conclusion 

The latest clearance reinforces Zydus’ momentum in the US oncology space and adds depth to its specialised injectables portfolio. With a growing pipeline and steady regulatory progress, the company is poised to enhance its presence in one of its most important markets. 

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