Galsulfase Iv Suppliers & Bulk Manufacturers
Available Forms: Lyophilized powder for IV
Available Strengths: 1mg/ml
Reference Brands: Vimizim®(US & EU)
Category:
Orphan Drugs
Galsulfase is an enzyme replacement therapy that provides the deficient N-acetylgalactosamine-6-sulfatase enzyme in Morquio A syndrome. It reduces the buildup of glycosaminoglycans in the body, improving mobility, breathing, and overall functioning, leading to enhanced quality of life in affected patients.
Galsulfase IV is available in Lyophilized powder for IV
and strengths such as 1mg/ml.
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, Galsulfase IV 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) |
Galsulfase IV 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.
Product Description:
Galsulfase, marketed as Vimizim®, is approved in the US and EU for mucopolysaccharidosis type IVA (Morquio A syndrome). Regulatory dossiers include comprehensive clinical trial data, manufacturing practices, and safety profiles submitted to FDA and EMA, supporting its approval. Dossiers demonstrate its efficacy in reducing symptoms and improving mobility. Administered via IV infusion, dosing is individualized according to patient weight. For in-depth insights on regulatory submissions, dossier requirements, and market approvals, visit PharmaTradz, your trusted source for pharmaceutical regulatory updates and industry insights.
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