Axatilimab‑Csfr Suppliers & Bulk Manufacturers
Available Forms: Injection
Available Strengths: 50 mg/mL
Reference Brands: Niktimvo (USA)
Category: Critical Care
Axatilimab‑csfr is available in Injection and strengths such as 50 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, Axatilimab‑csfr 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) |
Axatilimab‑csfr 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:
Axatilimab‑csfr, marketed under the brand name Niktimvo, is a humanized monoclonal antibody indicated for the treatment of chronic graft‑versus‑host disease (cGVHD) in adult and pediatric patients weighing at least 40 kg who have not responded to at least two prior systemic therapies. As a CSF‑1R blocker, axatilimab‑csfr specifically targets macrophages that drive inflammation and tissue fibrosis, reducing immune-mediated damage to transplanted tissues. By modulating these immune cells, it helps alleviate common cGVHD symptoms such as skin hardening, ulcers, and organ dysfunction. The therapy is administered as an intravenous injection under the supervision of healthcare professionals. Axatilimab‑csfr represents a crucial treatment option for patients with refractory cGVHD, offering potential improvements in quality of life when other therapies have failed. Commonly observed side effects include liver enzyme elevations, infections, and musculoskeletal pain, which are generally manageable with monitoring and supportive care. The medication is provided in single‑dose vials, typically at a concentration of 50 mg/mL, and is designed for administration in controlled healthcare settings to ensure safety and efficacy. Niktimvo provides a targeted, biologic-based therapy that addresses the underlying immune mechanisms of chronic graft‑versus‑host disease.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Frequently Asked Questions
Axatilimab‑csfr is used to treat chronic graft‑versus‑host disease (cGVHD) in patients who have failed at least two prior systemic therapies.
It is a humanized monoclonal antibody that targets the colony‑stimulating factor‑1 receptor (CSF‑1R) to reduce pro‑inflammatory and pro‑fibrotic immune cells.
The trade name is Niktimvo.
The generic name is axatilimab‑csfr.
The brand name is Niktimvo.
It is manufactured in facilities that comply with regulatory standards for biologic monoclonal antibody therapies.
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