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 is an enzyme replacement therapy that supplies the deficient acid α-glucosidase enzyme in Pompe disease. It breaks down glycogen in muscles, reducing accumulation. Benefits include improved muscle strength, respiratory function, and mobility, leading to better quality of life and slowed disease progression in Pompe patients. 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.

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.

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.