Lupin informed that it has received an approval from US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Minzoya (Levonorgestrel and Ethinyl Estradiol tablets, and Ferrous Bisglycinate tablets).
The approved ANDA is a generic equivalent of Balcoltra (Levonorgestrel and Ethinyl Estradiol tablets, and Ferrous Bisglycinate tablets) of Avion Pharmaceuticals, LLC.Minzoya tablets are indicated for use by females of reproductive potential to prevent pregnancy. The drug will be manufactured at Lupins Pithampur facility in India.
According to IQVIA MAT December 2023, Levonorgestrel and Ethinyl Estradiol tablets and Ferrous Bisglycinate tablets (RLD Balcoltra) had estimated annual sales of $42 million in the U.S.
Mumbai-based Lupin is an innovation-led transnational pharmaceutical company. It develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe and Middle East regions.
The pharmaceutical company reported consolidated net profit of Rs 613.12 crore in Q3 FY24, steeply higher than Rs 153.47 crore posted in Q3 FY23. Revenue from operations increased 19.67% YoY to Rs 5,079.88 crore in the quarter ended 31 December 2023.
Lupin rose 0.97% to end at Rs 1,620.65 on the BSE.
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