Basiliximab Injectable Solution Suppliers & Bulk Manufacturers
Available Forms: Injectable Solution
Available Strengths: 20 mg/vial
Reference Brands: Simulect(US)
Category:
Transplant
Basiliximab is a monoclonal antibody that targets the IL-2 receptor on activated T-cells, inhibiting their proliferation and immune response. It effectively reduces organ rejection in transplantation, supporting graft survival. Benefits include targeted immunosuppression, decreased rejection risk, and improved transplant outcomes, enhancing long-term graft function and patient survival.
Basiliximab Injectable Solution is available in Injectable Solution
and strengths such as 20 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, Basiliximab Injectable Solution 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) |
Basiliximab Injectable Solution 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:
Basiliximab injection, marketed as Simulect, is approved in the US by the FDA and in the EU via EMA for preventing organ rejection in kidney transplantation. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. The FDA reviews extensive clinical trial and quality data, while the EMA ensures compliance with safety and manufacturing regulations. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper regional adherence supports timely approval, safe use, and broad availability, helping transplant patients achieve graft survival and improve long-term outcomes worldwide.
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