Lupin : April 1, 2024 Lupin Receives Tentative Approval from U.S. FDA for Migalastat Capsules

Mumbai, Naples, April 01, 2024: Global pharma major Lupin Limited (Lupin) today 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.

Migalastat Capsules (RLD Galafold®) had global net sales of USD 388 million in the U.S. for the year ending December 2023.

About Lupin
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 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 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, more than 20,000 professionals working globally, and has been consistently recognized as a 'Great Place to Work' in the Biotechnology & Pharmaceuticals sector.

Please visit www.lupin.com for more information.
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For further information or queries please contact -
Heena Dhedhi
Deputy General Manager - Corporate Communications
Email: heenadhedhi@lupin.com

*Safe Harbor Statement
Galafold®is the registered trademark of Amicus Therapeutics, Inc.