Migalastat Hydrochloride Suppliers & Bulk Manufacturers
Available Forms: Capsules
Available Strengths: 123 mg
Reference Brands: Galafold (USA/EU)
Category: Orphan Drugs
Migalastat is an orally administered small molecule that acts as a “pharmacological chaperone” by binding and stabilizing the enzyme α-galactosidase A (α-Gal A) in patients with certain amenable mutations, thereby helping to clear the substrate accumulation seen in Fabry disease. Migalastat Hydrochloride is available in Capsules and strengths such as 123 mg. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Migalastat Hydrochloride is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.
| Technical Specifications & Supply Details | |
|---|---|
| Lead Time | 7 to 60 days (depending on batch size & schedule) |
| MOQ | As per manufacturer’s batch size |
| COA | Available with every batch |
| Regulatory Dossier / DMF | Available upon request |
| Export Documentation | FSC, COA, Manufacturing License, Product Permission |
| Standards | IP, BP, USP |
| Certifications | WHO-GMP, EU-GMP, USFDA (as applicable) |
Migalastat Hydrochloride can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Frequently Asked Questions
Migalastat Hydrochloride is used for the long-term treatment of adults with Fabry disease, a rare genetic disorder caused by deficient activity of the enzyme alpha-galactosidase A. It helps stabilize and enhance the function of certain mutant forms of the enzyme, reducing the accumulation of harmful substances in the body.
Migalastat Hydrochloride is made from the active ingredient migalastat hydrochloride, an oral pharmacological chaperone that binds selectively to specific mutant forms of alpha-galactosidase A, allowing the enzyme to fold correctly and function more effectively.
Migalastat Hydrochloride is marketed under the trade name Galafold.
Migalastat Hydrochloride is manufactured by Amicus Therapeutics.
The generic name of Migalastat Hydrochloride is Migalastat Hydrochloride.
The brand name of Migalastat Hydrochloride is Galafold.
Migalastat Hydrochloride is manufactured in the United States and the European Union by Amicus Therapeutics and its contract manufacturing partners.
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