Lupin Limited’s shares were up by 0.40 per cent after the company secured an approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application regarding Ganirelix Acetate Injection. This approval allows Lupin to market a generic equivalent of Organon USA LLC’s reference listed drug (RLD), Ganirelix Acetate Injection, in the form of a 250 mcg/0.5 mL Single-Dose Prefilled Syringe.
Marked as Lupin’s inaugural peptide-based injectable, the manufacturing of Ganirelix Acetate Injection will take place at Lupin’s Nagpur facility in India. Ganirelix Acetate Injection is intended for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation.
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According to the company, with estimated annual sales of USD 84 million in the U.S. as of September 2023 (IQVIA MAT September 2023), this development opens avenues for Lupin in the generic pharmaceutical market.
The shares were up by 0.40 per cent to ₹1,198 at 3 pm on the BSE.