Belatacept Injection Suppliers & Bulk Manufacturers
Available Forms: Injection
Available Strengths: 250 mg/vial
Reference Brands: Nulojix(US)
Category:
Transplant
Belatacept is a fusion protein that blocks CD80/CD86 on immune cells, preventing T-cell activation. It effectively reduces kidney transplant rejection, supports long-term graft survival, and decreases the need for intensive immunosuppressants. Benefits include targeted immunosuppression, fewer side effects, and improved quality of life for transplant recipients.
Belatacept injection is available in Injection
and strengths such as 250 mg/vial.
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, Belatacept 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) |
Belatacept 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:
Belatacept, marketed as Nulojix, is approved in the US by the FDA and in the EU via EMA for rejection prevention in adult kidney transplant recipients. Regulatory approval requires comprehensive dossiers, including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. The FDA reviews detailed clinical trial and quality information, while the EMA ensures compliance with regional safety and manufacturing regulations. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring proper regional adherence supports timely approval, safe use, and global availability, helping transplant patients achieve optimal long-term outcomes and graft survival worldwide.
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