Lupin Limited bags FDA approval for Generic Ganirelix Acetate Injection

Lupin Limited, a global pharma major, has announced its receipt of approval from the United States Food and Drug Administration (U.S. FDA) for Ganirelix Acetate Injection. This milestone authorizes Lupin to market a generic equivalent to the reference listed drug (RLD) of Ganirelix Acetate Injection, 250 mcg/0.5 mL, originally of Organon USA LLC.

Lupin’s First Peptide-Based Injectable

This approval marks Lupin’s first foray into the peptide-based injectable market, reinforcing the company’s dedication to offering innovative healthcare solutions. The Ganirelix Acetate Injection, manufactured at Lupin’s state-of-the-art facility in Nagpur, India, is poised to make a significant impact in the healthcare field.

Lupin enters the peptide injectable market with FDA-approved Ganirelix Acetate

Therapeutic Use and Market Potential

Ganirelix Acetate Injection is primarily indicated for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation. With its therapeutic effectiveness, the product addresses a crucial need in women’s health. According to IQVIA MAT data as of September 2023, Ganirelix Acetate Injection had estimated annual sales of USD 84 million in the U.S., indicating its substantial market potential.

Lupin’s Continued Commitment to Healthcare

Lupin’s latest achievement in receiving FDA approval exemplifies the company’s commitment to expanding its pharmaceutical portfolio and contributing to global healthcare advancements. By entering the peptide-based injectable segment, Lupin strengthens its position as a key player in the pharmaceutical industry, offering diverse and effective medical treatments.