Lupin's Efinaconazole Topical Solution gets USFDA nod
Lupin today announced that it has received approval from the USFDA for its ANDA, Efinaconazole Topical Solution, 10%to market a generic equivalent of Jublia Topical Solution, 10%, of Bausch Health Americas, Inc..
Mumbai: Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Efinaconazole Topical Solution, 10%to market a generic equivalent of Jublia® Topical Solution, 10%, of Bausch Health Americas, Inc. The product will be manufactured at Lupin's facility in Pithampur, India.
Efinaconazole Topical Solution, 10%(RLD: Jublia® Topical Solution, 10%) had estimated annual sales of USD 274million in the U.S. (IQVIA MAT December 2021).
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.Lupin's R&D effort is aligned with our enterprise goal — to bring affordable, quality medicines to market in order to address unmet patient needs.
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The Company enjoys a leadership position 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. Lupin commenced operations as a manufacturer of vitamins, and soon started producing drugs to combat tuberculosis (TB). Over the years, Lupin has grown and expanded into new areas and regions, manufacturing drugs that extend the promise of good health to communities across the globe. Beginning with two employees — a peon-cum-packer and a part-time typist — Lupin's current global footprint spans 11 countries, across six continents. The Intellectual Property Management Group (IPMG) at Lupin is responsible for creating, securing and leveraging advanced research to build a high-value portfolio of patents, products and research pipeline products.
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