Lisocabtagene Maraleucel Infusion Suppliers & Bulk Manufacturers
Available Forms: IV Infusion
Available Strengths: Approved for relapsed/refractory large B-cell lymphoma, with a standard dose of 100 million CAR T cells per infusion
Reference Brands: Breyanzi (US & EU)
Category:
Cell & Gene Therapies
Lisocabtagene maraleucel (Breyanzi) is a CAR T-cell therapy that reprograms a patient’s T cells to target CD19-positive cancer cells. It offers rapid, targeted tumor destruction, providing durable remissions, improved survival, and quality of life for relapsed/refractory large B-cell lymphoma patients when administered in specialized treatment centers.
Lisocabtagene maraleucel Infusion is available in IV Infusion
and strengths such as Approved for relapsed/refractory large B-cell lymphoma, with a standard dose of 100 million CAR T cells per infusion.
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, Lisocabtagene maraleucel 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) |
Lisocabtagene maraleucel 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:
Lisocabtagene maraleucel (Breyanzi) is regulated in the EU and US, supported by dossiers demonstrating safety, efficacy, and manufacturing quality in accordance with GMP and MDR standards. In the US, FDA approval involved rigorous clinical validation and safety assessments. In the EU, CE marking certifies conformity with MDR. The product undergoes validation, stability testing, and audits, with comprehensive 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 CAR T-cell therapies supporting treatment of relapsed/refractory lymphomas worldwide, improving patient outcomes and quality of life.
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