Lupin Limited introduced Ganirelix Acetate Injection, 250 mcg/0.5 mL, Single-Dose Prefilled Syringe, in the United States market. This launch marks Lupin’s entry into the peptide-based injectable segment. The product has received approval from the United States Food and Drug Administration (US FDA) and is a generic equivalent to the reference listed drug (RLD), Ganirelix Acetate Injection, 250 mcg/0.5 mL, manufactured by Organon USA LLC. Ganirelix Acetate Injection is indicated for inhibiting premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation.
- Also read: Lupin receives USFDA approval for Propranolol Hydrochloride extended-release capsules USP
The company said that Ganirelix Acetate Injection is expected to address market opportunity, with estimated annual sales of $87 million in the U.S. as of December 2023 (IQVIA MAT data).
Lupin Limited, headquartered in Mumbai, India, is a pharmaceutical company. The company develops and commercialises branded and generic formulations, biotechnology products, and APIs across various therapeutic areas. Lupin majors in the cardiovascular, anti-diabetic, and respiratory segments and has a strong presence in other areas such as anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health.
The company’s shares fell 0.46 per cent to ₹1,602.25 at 1.54 pm on the BSE.