Indian pharma major Lupin Limited said that it has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Ganirelix Acetate Injection.
Ganirelix is Lupin's first peptide-based injectable, the company said in a press statement on November 16.
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 $84 million in the US, according to IQVIA MAT September 2023 data.
Earlier, on November 8, Lupin had reported a 3.77-fold year-on-year rise in consolidated net profit at Rs 489.6 crore for the July-September quarter of the current financial year. The company had reported a profit of Rs 129.7 crore in the same period last year.
Revenue came in at Rs 5038.56 crore, up 24.9 percent from the year-ago quarter numbers of Rs 4145.5 crore.
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