India Pharma Outlook Team | Saturday, 15 November 2025
Zydus Lifesciences has secured final approval from the United States Food and Drug Administration (USFDA) for its Leuprolide Acetate injection, 14 mg/2.8 mL (1 mg/0.2 mL) multiple-dose vial, the generic equivalent of Lupron Injection (1 mg/0.2 mL). This product is prescribed for the palliative management of advanced prostate cancer.
The approved Leuprolide Acetate injection will be produced at the company’s state-of-the-art oncology injectable manufacturing facility located at SEZ-1, Ahmedabad (ALIDAC).
In the U.S. market, Leuprolide Acetate injection registered annual sales of USD 69 million, as per IQVIA MAT September 2025.
Zydus Lifesciences Limited, previously known as Cadila Healthcare Limited, stands among India’s leading pharmaceutical enterprises and is globally recognized for its fully integrated healthcare capabilities.
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The company’s strengths span the entire pharmaceutical value chain ranging from formulations and active pharmaceutical ingredients to animal health and wellness products. Through these diverse offerings, Zydus has established itself as a trusted provider of wide-ranging healthcare solutions.
The company draws its strength from a rich legacy that dates back to the 1950s. Founded in 1952 by the late Mr. Ramanbhai B. Patel, an influential first-generation entrepreneur, Zydus has grown from a visionary idea into a respected name in Indian pharmaceuticals.
A major milestone came in 1995 with the restructuring of the group, leading to the formation of Cadila Healthcare under the Zydus umbrella. Since then, the company has experienced extraordinary growth, expanding from a turnover of 250 crore in 1995 to over 23,200 crore in FY-25.
Remaining true to its commitment of being “dedicated to life in all its dimensions,” Zydus continues to innovate with the aim of addressing unmet medical needs. Alongside this scientific focus, the organization remains steadfast in its mission to foster healthier and happier communities worldwide.
