Ofatumumab Injection 20 mg/mL 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.
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.
Ofatumumab Injection — third party manufacturing & bulk supply
Ofatumumab Injection 20 mg/mL 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 Ofatumumab Injection 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.
Request a quote for Ofatumumab Injection →The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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