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.
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.
Tisagenlecleucel Infusion — third party manufacturing & bulk supply
Tisagenlecleucel Infusion is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:
What to include when you enquire
- Destination market — determines which manufacturers hold the right site-level approvals
- First order quantity and estimated annual volume
- Whether you need a registration dossier or the product is already registered
- Packaging, labelling and language requirements
- Incoterms and required shelf life
Indicative minimum order quantity
Tisagenlecleucel Infusion is supplied as IV Infusion — an injectable dosage form, so the indicative MOQ is 50,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.
Manufacturers of Tisagenlecleucel Infusion listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.
Request a quote for Tisagenlecleucel Infusion →The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Frequently Asked Questions
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