Axicabtagene Ciloleucel Infusion Suppliers & Bulk Manufacturers
Available Forms: IV Infusion
Available Strengths: Single infusion treatment approved for relapsed/refractory large B-cell lymphoma, with dosing based on patient weight
Reference Brands: Yescarta (US & EU)
Category:
Cell & Gene Therapies
Axicabtagene ciloleucel is a CAR T-cell therapy that reprograms a patient’s T cells to target CD19-positive cancer cells. It provides rapid, targeted destruction of lymphoma cells, offering durable remissions, improved survival, and quality of life for patients with relapsed or refractory large B-cell lymphoma when administered in specialized centers.
Axicabtagene Ciloleucel Infusion is available in IV Infusion
and strengths such as Single infusion treatment approved for relapsed/refractory large B-cell lymphoma, with dosing based on patient weight.
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, Axicabtagene Ciloleucel Infusion 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) |
Axicabtagene Ciloleucel Infusion 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:
Axicabtagene ciloleucel (Yescarta) is regulated in the EU and US, supported by dossiers demonstrating safety, efficacy, and manufacturing quality compliant with GMP and MDR standards. In the US, FDA approval involves extensive clinical validation and safety assessments. In the EU, CE marking certifies conformity with MDR regulations. These CAR T-cell therapies undergo validation, stability testing, and audits, with detailed documentation including clinical trial data, safety profiles, and manufacturing practices. For licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to innovative, life-saving immunotherapies supporting advanced cancer treatments worldwide.
Disclaimer: By continuing to browse, you agree to the terms of use of this website and the Trade Marks displayed, in compliance with the provisions of the Trademark Act, 1999, Section 30 and 30(1) under 'Fair use.'
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Back to Listing