Lupin Ltd announced on Thursday that it has launched Ganirelix Acetate Injection in the United States, indicated to inhibit premature luteinizing hormone surges in women.
The pharmaceutical company informed the stock exchanges that it has received approval from the United States Food and Drug Administration (USFDA) for launching the Ganirelix Acetate Injection in the country.
The US health regulator has approved the launch of the Ganirelix Acetate Injection in the dosage of 250 mcg/0.5 mL, in a single-dose prefilled syringe.
The injection is recommended in fertility treatment to prevent luteinizing hormone (LH) surges or ovulation in women undergoing controlled ovarian hyperstimulation.
The Ganirelix Acetate Injection is a generic equivalent of Ganirelix Acetate Injection in the same dose (250 mcg/0.5 mL), the reference listed drug (RLD) of the US-based pharma company Organon USA LLC.
As per IQVIA MAT data for December 2023, the Ganirelix Acetate Injection had an estimated annual sale of $87 million in the United States.
Last week, Lupin reported a 299.6% year-on-year (YoY) growth in net profit at ₹613.1 crore for the third quarter ended December 31, 2023, compared to ₹153.4 crore in the same period last year. Its revenue from operations grew 20.2% to ₹5,197.4 crore from ₹4,322.2 crore in the corresponding quarter of the previous fiscal year.
The company’s margin rose to 20% in Q3FY24, up from 12.3% in the same period last year.
Shares of Lupin were trading 0.63% lower at ₹1,599.5 apiece in BSE at 2:06 PM.
(Edited by : Ajay Vaishnav)
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