Migalastat Hydrochloride bulk supplier for pharma manufacturers

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.

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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.

Yes, Migalastat Hydrochloride is available with DMF and other regulatory documents such as COA and MSDS. These can be provided upon request for qualified buyers.

Absolutely. Sample requests are accepted for formulation trials and quality checks. Please submit an enquiry to initiate the process.

Our manufacturing partners are GMP-certified and comply with ISO and WHO standards, ensuring global quality benchmarks.

Lead times vary based on quantity and destination, but most orders are fulfilled within 1–3 weeks. Express shipping options are available.

Yes, Migalastat Hydrochloride is exported to over 30 countries across Asia, Africa, Europe, and Latin America. We support documentation for customs and regulatory clearance.

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