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Lupin added 1.65% to Rs 1,993.60 after the pharma major announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its abbreviated new drug application (ANDA) for Amifampridine Tablets, 10 mg.
Amifampridine Tablets, 10 mg, are bioequivalent to Firdapse Tablets, 10 mg, from Catalyst Pharmaceuticals, Inc., and are indicated for the treatment of Lambert-Eaton Myasthenic Syndrome in adults and pediatric patients 6 years of age and older. This product will be manufactured at Lupin's Goa facility in India.
Amifampridine Tablets, 10 mg (RLD Firdapse), had an estimated global net sale of $306 million for the fiscal year ended 31 December 2024.
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 US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
Lupin's consolidated net profit jumped 38.81% to Rs 858.86 crore on a 10.60% increase in sales to Rs 5,618.6 crore in Q3 FY25 compared to Q3 FY24.
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