Lupin Ltd's shares gained 2% on Friday (February 16) after the company announced receiving approval from the United States Food and Drug Administration (USFDA) for a generic drug to prevent pregnancy.
The leading global pharma company, in a filing to the stock exchanges, said that it has received approval from the US drug regulator for its Abbreviated New Drug Application (ANDA) for Minzoya tablets. The Minzoya tablets are used by women of reproductive potential to prevent pregnancy, the company informed the bourses.
Minzoya (Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ferrous Bisglycinate tablets) is a generic equivalent of Balcoltra (Levonorgestrel and Ethinyl Estradiol tablets, USP, and Ferrous Bisglycinate tablets), the company said. The product will be manufactured at the company's Pithampur facility in Madhya Pradesh.
The US health regulator has approved the launch of Minzoya tablets in the dosage of 0.1 mg/0.02 mg and 36.5 mg. Levonorgestrel and Ethinyl Estradiol Tablets, USP, and Ferrous Bisglycinate Tablets are estimated to have annual sales of over $42 million in the US, according to IQVIA MAT December 2023 data.
The new approval comes days after Lupin launched the Ganirelix Acetate Injection in the United States. The injection is used in fertility treatment in women.
The company had received USFDA approval to launch the injection in the dosage of 250 mcg/0.5 mL, in a single-dose prefilled syringe. The Ganirelix Acetate Injection is a generic equivalent of Ganirelix Acetate Injection in the same dose.
Lupin's share prices have maintained a steady upward trend since the announcement of its performance report for the quarter ending in December 2023.
The company has reported a 299.6% year-on-year (YoY) spike in its net profit. From ₹153.4 crore in Q3FY23, Lupin's net profit rose to ₹613.1 crore in the third quarter of the current financial year. The company's revenue from operations also jumped 20.2% to ₹5,197.4 crore in Q3FY24 from ₹4,322.2 crore in the year-ago period.
Shares of Lupin Ltd were trading 1.27% higher at ₹1,625.55 apiece, up 1.27%, on BSE at 2:30 PM.
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