Lupin advanced 3.59% to Rs 677.45 after the drug maker said that it has received ANDA approval for its Mirabegron extended-release tablet from the US Food and Drug Administration (USFDA).
The approved abbreviated new drug application (ANDA) is generic equivalent of Myrbetriq extended-release tablets of Astellas Pharma Global Development, Inc.The pharma major said that the product will be manufactured at Lupin's facility in Nagpur, India.
Myrbetriq is used by adults to treat overactive bladder with symptoms of frequent or urgent urination and urinary incontinence. It is also used by children to treat neurogenic detrusor overactivity (NDO).
According to IQVIA MAT June 2022, Mirabegron extended-release tablet had estimated annual sales of $2403 million in the United States.
The drug maker reported a net loss of Rs 89.1 crore in Q1 FY23 as against a net profit of Rs 542.5 crore in Q1 FY22. Total revenue from operations declined 12.3% YoY to Rs 3,743.8 crore during the quarter.
Lupin is an innovation-led transnational pharmaceutical company. The company 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.
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