Lupin receives approval from U.S. FDA for Ganirelix Acetate Injection

Global pharma major Lupin Limited (Lupin) today announced that it 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, 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.

Ganirelix Acetate Injection had estimated annual sales of USD 84 million in the U.S. (IQVIA MAT September 2023).

Shares of Lupin Limited was last trading in BSE at Rs. 1196.30 as compared to the previous close of Rs. 1193.80. The total number of shares traded during the day was 16793 in over 918 trades.

The stock hit an intraday high of Rs. 1211.10 and intraday low of 1180.65. The net turnover during the day was Rs. 20165054.00.

Source : Equity Bulls

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Lupin INE326A01037 USFDA Approval ANDA GanirelixAcetateInjection