November 17, 2023 Lupin Receives Approval from U.S.FDA for Ganirelix Acetate Injection

Mumbai, Baltimore, November 17, 2023: Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (U.S.FDA) for its Abbreviated New Drug Application for Ganirelix Acetate Injection, 250 mcg/0.5 mL Single-Dose Prefilled Syringe, to market a generic equivalent to the reference listed drug (RLD), of Ganirelix Acetate Injection, 250 mcg/0.5 mL of Organon USA LLC. Ganirelix is Lupin's first peptide-based injectable, strengthening the Company's commitment to innovative healthcare solutions. The product will be manufactured at Lupin's Nagpur facility in India.

Ganirelix Acetate Injection is indicated for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation.

Ganirelix Acetate Injection had estimated annual sales of USD 84 million in the U.S. (IQVIA MATSeptember2023).

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 7.9% of its revenue in research and development in FY23.

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 -
Shweta Munjal
Vice President & Global Head - Corporate Communications& Sustainability
Email: [email protected]