Alglucosidase Alfa Iv Suppliers & Bulk Manufacturers
Available Forms: Lyophilized powder
Available Strengths: 50 mg/vial
Reference Brands: Lumizyme®(US & EU)
Category: Orphan Drugs
Alglucosidase Alfa IV is available in Lyophilized powder and strengths such as 50 mg/vial. 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, Alglucosidase Alfa 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) |
Alglucosidase Alfa 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: Alglucosidase alfa, marketed as Lumizyme® and Myozyme®, is approved in the US and EU for Pompe disease. Regulatory dossiers include extensive clinical trial data, manufacturing standards, and safety profiles submitted to the FDA and EMA, supporting approval for intravenous use. Dossiers demonstrate its efficacy in improving muscle strength, breathing, and mobility. Dosing is individualized based on patient weight and disease severity. For detailed insights on regulatory processes, dossier submissions, and market approvals in the EU and US, visit PharmaTradz, your trusted source for pharmaceutical regulatory insights and industry updates.
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