Lupin’s Alliance Partner ForDoz Receives U.S. FDA Approval for Doxorubicin Hydrochloride Liposome Injection

Mumbai, Naples, July 19, 2024: Global pharma major Lupin Limited (Lupin) today announced that its alliance partner, ForDoz Pharma Corporation, USA (ForDoz) has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Doxorubicin Hydrochloride Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) Single-Dose Vials, to market a generic equivalent of Doxil® Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL), of Baxter Healthcare Corporation.

Doxorubicin Hydrochloride Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) Single-Dose Vials are indicated for treatment of ovarian cancer, acquired immune deficiency syndrome (AIDS)-related Kaposi’s Sarcoma, and multiple myeloma.

Doxorubicin Hydrochloride Liposome Injection (RLD Doxil®) had estimated annual sales of USD 42 million in the U.S. (IQVIA MAT May 2024).

About Lupin

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The Company enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 7.8% of its revenue in research and development in FY24.

Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.

Please visit www.lupin.com for more information.

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For further information or queries please contact –

Rajalakshmi Azariah

Vice President & Global Head – Corporate Communications, Lupin

rajalakshmiazariah@lupin.com

*Safe Harbor Statement

Doxil® is a registered trademark of Baxter International Inc.