Alglucosidase Alfa Iv 50 mg/vial 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.
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.
Alglucosidase Alfa Iv — third party manufacturing & bulk supply
Alglucosidase Alfa Iv 50 mg/vial is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:
What to include when you enquire
- Destination market — determines which manufacturers hold the right site-level approvals
- First order quantity and estimated annual volume
- Whether you need a registration dossier or the product is already registered
- Packaging, labelling and language requirements
- Incoterms and required shelf life
Manufacturers of Alglucosidase Alfa Iv listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.
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