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 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.

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.