Lupin Receives US FDA Tentative Approval for Migalastat Capsules

Lupin Receives US FDA Tentative Approval for Migalastat Capsules

By, Admin 2 April 2024

Overview

Global pharma major Lupin Limited (Lupin) announced that it has received tentative approval from the United States Food and Drug Administration (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.

Indication

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.

Annual sale

Migalastat capsules (Galafold) had estimated annual sales of USD 388 million in the US (IQVIA MAT 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 US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

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