Lupin Secures US FDA Approval for Ganirelix Acetate Injection

Lupin Limited (Lupin) announced that the United States Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application for Ganirelix Acetate injection, 250 mcg/0.5 mL single-dose prefilled syringe, to market a generic equivalent to Organon USA LLC's Ganirelix Acetate injection 250 mcg/0.5 mL.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, as per pharmabiz.In the United States, Ganirelix Acetate injection has an expected yearly sales of USD 84 million. September 2023 (IQVIA MAT).Lupin is a worldwide pharmaceutical firm based in Mumbai, India that focuses on innovation. The firm develops and commercializes a diverse variety of branded and generic formulations, biotechnology products and APIs in over 100 markets worldwide, including the United States, India, South Africa, and Asia Pacific (APAC), Latin America (LATAM), Europe, and the Middle East.We have evolved as a leader in generics, complex generics, APIs, specialty, and biologics due to our solid production capabilities and outstanding R&D. Lupin's dedication to innovation and patient-centeredness has propelled the company's success in therapeutic areas such as cardiovascular health, TB, diabetes, respiratory, gastrointestinal diseases, and women's health.