Alemtuzumab Injection Suppliers & Bulk Manufacturers
Available Forms: Injection
Available Strengths: 12 mg/1,2 ml
Reference Brands: Lemtrada(US & EU)
Category:
Multiple sclerosis
Alemtuzumab is a monoclonal antibody targeting CD52 on lymphocytes, leading to immune cell depletion. It reduces MS relapses, disease activity, and lesions by modulating the immune response. Benefits include long-lasting disease control, fewer relapses, and improved quality of life in relapsing-remitting multiple sclerosis patients.
Alemtuzumab injection is available in Injection
and strengths such as 12 mg/1,2 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, Alemtuzumab injection 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) |
Alemtuzumab injection 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:
Alemtuzumab IV solution, marketed as Lemtrada, is approved in the US by the FDA and in the EU via EMA for relapsing-remitting multiple sclerosis. Regulatory approval demands a comprehensive dossier including clinical trial data, safety profiles, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews detailed clinical efficacy and safety data, while the EMA ensures regional compliance with safety and quality standards.
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