Lupin receives tentative approval from US FDA for Migalastat caps

The product will be manufactured at Lupin’s Goa facility in India

Lupin has received tentative approval from the United States Food and Drug Administration (US 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. 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 $388 million in the US for the year ending December 2023.