Galsulfase Iv Suppliers & Bulk Manufacturers
Available Forms: Lyophilized powder for IV
Available Strengths: 1mg/ml
Reference Brands: Vimizim®(US & EU)
Category: Orphan Drugs
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.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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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