Lupin secures USFDA okay for Prasugrel tablets used in heart ailments
Mumbai: Global pharma major Lupin Limited has announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA), Prasugrel Tablets USP, 5 mg and 10 mg used in heart ailments.
The product is a generic equivalent of Effient Tablets, 5 mg and 10 mg of Cosette Pharmaceuticals, Inc.
The product will be manufactured at Lupin’s facility in Goa, India. Prasugrel Tablets USP, 5 mg and 10 mg, (RLD Effient) had estimated annual sales of USD 18 million in the U.S. (IQVIA MAT September 2022).
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. 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.
Read also: Lupin unveils fixed-dose triple drug combination DIFIZMA DPI for inadequately controlled asthma
The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. The company invested 8.7% of its revenue in research and development in FY22.
Lupin has 15 manufacturing sites, 7 research centers, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector
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