Axicabtagene Ciloleucel Infusion bulk supplier for pharma manufacturers

Axicabtagene Ciloleucel Infusion Suppliers & Bulk Manufacturers

Available Forms: IV Infusion

Available Strengths: Single infusion treatment approved for relapsed/refractory large B-cell lymphoma, with dosing based on patient weight

Reference Brands: Yescarta (US & EU)

Category: Cell & Gene Therapies

Axicabtagene Ciloleucel Infusion is available in IV Infusion and strengths such as Single infusion treatment approved for relapsed/refractory large B-cell lymphoma, with dosing based on patient weight. 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, Axicabtagene Ciloleucel 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)

Axicabtagene Ciloleucel 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.

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Product Description:

Axicabtagene ciloleucel (Yescarta) is regulated in the EU and US, supported by dossiers demonstrating safety, efficacy, and manufacturing quality compliant with GMP and MDR standards. In the US, FDA approval involves extensive clinical validation and safety assessments. In the EU, CE marking certifies conformity with MDR regulations. These CAR T-cell therapies undergo validation, stability testing, and 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, life-saving immunotherapies supporting advanced cancer treatments worldwide.

Frequently Asked Questions

Yes, Axicabtagene Ciloleucel Infusion is available with DMF and other regulatory documents such as COA and MSDS. These can be provided upon request for qualified buyers.

Absolutely. Sample requests are accepted for formulation trials and quality checks. Please submit an enquiry to initiate the process.

Our manufacturing partners are GMP-certified and comply with ISO and WHO standards, ensuring global quality benchmarks.

Lead times vary based on quantity and destination, but most orders are fulfilled within 1–3 weeks. Express shipping options are available.

Yes, Axicabtagene Ciloleucel Infusion is exported to over 30 countries across Asia, Africa, Europe, and Latin America. We support documentation for customs and regulatory clearance.

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