Lupin gets USFDA approval for Ganirelix Acetate Injection

Mumbai: Global pharma major Lupin Limited has announced that the Company 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. 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 MAT September 2023).

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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 specializes 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. The company invested 7.9% of its revenue in research and development in FY23. Lupin has 15 manufacturing sites and 7 research centers.

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