Lupin bags tentative USFDA nod for Migalastat Capsules
Migalastat Capsules are indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data.
Mumbai: Global pharma major Lupin Limited has announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Migalastat Capsules, 123 mg, to market a generic equivalent of Galafold Capsules, 123 mg of Amicus Therapeutics US LLC.
This product will be manufactured at Lupin’s Goa facility in India.
Migalastat Capsules are indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data.
Fabry disease is a rare genetic disorder characterized by the buildup of a specific type of fat in cells throughout the body due to a deficiency in the enzyme alpha-galactosidase A. This buildup can lead to various symptoms including pain, skin abnormalities, kidney dysfunction, and heart complications.
Migalastat Capsules (RLD Galafold) had global net sales of USD 388 million in the U.S. for the year ending December 2023.
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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.
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. Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 7.9% of its revenue in research and development in FY23.
Lupin has 15 manufacturing sites, 7 research centers.
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