Ofatumumab Injection Suppliers & Bulk Manufacturers
Available Forms: Injection(SQ)
Available Strengths: 20 mg/mL
Reference Brands: Kesimpta(US)
Category:
Multiple sclerosis
Ofatumumab blocks CD20 on B-cells, reducing their activity and decreasing inflammation in multiple sclerosis. It lowers relapse rates, slows disease progression, and reduces lesion activity. Benefits include targeted immune suppression, self-administration via subcutaneous injection, improved disease control, and enhanced quality of life for relapsing MS patients.
Ofatumumab Injection is available in Injection(SQ)
and strengths such as 20 mg/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, Ofatumumab 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) |
Ofatumumab 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:
Ofatumumab, marketed as Kesimpta, is approved in the US by the FDA and in the EU via EMA for relapsing multiple sclerosis. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing quality, and pharmacovigilance plans. In the US, the FDA reviews detailed clinical trial and safety data, while the EMA ensures compliance with regional safety and quality standards.
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