
Basiliximab Injectable Solution Suppliers & Bulk Manufacturers
Available Forms: Injectable Solution
Available Strengths: 20 mg/vial
Reference Brands: Simulect(US)
Category: Transplant
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.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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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