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Lisocabtagene maraleucel Infusion bulk supplier for pharma manufacturers

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.

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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.

Lisocabtagene Maraleucel Infusion — third party manufacturing & bulk supply

Lisocabtagene Maraleucel 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:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.
Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.
Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

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

Lisocabtagene Maraleucel 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 Lisocabtagene Maraleucel 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.

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Frequently Asked Questions

Lisocabtagene maraleucel Infusion is listed as IV Infusion in Approved for relapsed/refractory large B-cell lymphoma, with a standard dose of 100 million CAR T cells per infusion. Further strengths and pack presentations are confirmed with the manufacturer at RFQ stage.

Lisocabtagene maraleucel Infusion is referenced against Breyanzi (US & EU). Reference brands are shown for identification only and remain the property of their respective trademark owners.

Lisocabtagene maraleucel Infusion is catalogued under Cell & Gene Therapies on PharmaTradz. Related products within the same category are listed at the foot of this page.

Submit an RFQ stating your destination market, required quantity and whether you need stock supply, third party manufacturing or dossier licensing. Matched suppliers respond with pricing, MOQ and lead times.

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