Alemtuzumab Injection Suppliers & Bulk Manufacturers

Available Forms: Injection

Available Strengths: 12 mg/1,2 ml

Reference Brands: Lemtrada(US & EU)

Category: Multiple sclerosis

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.

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. For guidance on dossier preparation, regulatory pathways, and market access strategies, visit PharmaTradz. Proper compliance is crucial for timely approval, safe use, and global availability, supporting effective MS management worldwide.