Lupin's Migalastat Capsules Earn US FDA Tentative Approval

An FDA nod to the Abbreviated New Drug Application submitted (ANDA) by multinational pharma player Lupin Limited (Lupin) has come in. To join the current market, the company will introduce the generic version of Galafold capsules, 123 mg, from Amicus Therapeutics US LLC. The product will be produced at Lupin’s Barnm-India plant and sold only in US markets.

Suppose you have a confirmed diagnosis of Fabry disease, and your GLA mutation is recognized as an amenable variant according to the in vitro data. In that case, Migalastat capsules may be indicated for your treatment.

Migalastat capsule (Galafold) was forecasted to peak at USD 388 million of estimated annual sales in the US through the prior year (IQVIA MAT December 2023).

Lupin is an agile company in the pharmaceuticals sector, boasting its headquarters in Mumbai. From US brand-generic formulations over biotechnology products or APIs to approx. In 100 countries in America, South Africa, Asia Pacific, and Europe, this company commercializes its branded and generic products in over 100 markets worldwide