Ofatumumab Injection bulk supplier for pharma manufacturers

Ofatumumab Injection 20 mg/mL Suppliers & Bulk Manufacturers

Available Forms: Injection(SQ)

Available Strengths: 20 mg/mL

Reference Brands: Kesimpta(US)

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.

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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:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.

Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.

Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Ofatumumab Injection is supplied as Injection(SQ) — an injectable dosage form, so the indicative MOQ is 50,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and 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.

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Frequently Asked Questions

Ofatumumab Injection is listed as Injection(SQ) in 20 mg/mL. Further strengths and pack presentations are confirmed with the manufacturer at RFQ stage.

Ofatumumab Injection is referenced against Kesimpta(US). Reference brands are shown for identification only and remain the property of their respective trademark owners.