Tisagenlecleucel Infusion Suppliers & Bulk Manufacturers
Available Forms: IV Infusion
Available Strengths: Single infusion, approved for relapsed/refractory B-cell precursor acute lymphoblastic leukemia (ALL) and diffuse large B-cell lymphoma (DLBCL)
Reference Brands: Kymriah(US & EU)
Category:
Cell & Gene Therapies
Tisagenlecleucel is a CAR T-cell therapy that reprograms a patient's T cells to target and destroy CD19-positive cancer cells. It offers targeted treatment for refractory B-cell cancers, providing rapid remission, improved survival rates, and the potential for long-term disease control in leukemia and lymphoma patients when administered in specialized centers.
Tisagenlecleucel Infusion is available in IV Infusion
and strengths such as Single infusion, approved for relapsed/refractory B-cell precursor acute lymphoblastic leukemia (ALL) and diffuse large B-cell lymphoma (DLBCL).
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, Tisagenlecleucel 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) |
Tisagenlecleucel 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:
Tisagenlecleucel (Kymriah) is regulated in the EU and US, supported by dossiers demonstrating safety, efficacy, and manufacturing quality according to GMP and MDR standards. In the US, FDA approval involves extensive clinical validation for refractory B-cell malignancies, including safety monitoring. In the EU, CE marking certifies conformity with MDR regulations. These CAR T-cell therapies undergo validation, stability testing, and rigorous 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, effective immunotherapies supporting advanced cancer treatment worldwide.
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