Busulfan bulk supplier for pharma manufacturers

Busulfan Suppliers & Bulk Manufacturers

Available Forms: Injection, tablets

Available Strengths: Injection 6 mg/mL (60 mg/10 mL); tablets 2 mg

Reference Brands: Myleran, Busulfex (US)

Busulfan is used in the treatment of some cancers of blood like chronic myeloid leukaemia. It is used in combination with other cancer medicines during hematopoietic progenitor cell transplantation (HPCT). It may also be used to treat some other types of cancer.

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Product Description:

Busulfan is a bifunctional alkylating agent that cross-links DNA. Its selectivity is for myeloid progenitor cells, which is why it was used for decades to control chronic myeloid leukaemia before targeted therapy, and why it is now used at much higher doses to empty the bone marrow entirely before stem cell transplantation.

Its main use today is conditioning before haematopoietic stem cell transplant, usually with cyclophosphamide or fludarabine. The intravenous formulation exists because oral absorption is erratic, and exposure matters enormously here: too little risks graft failure or relapse, too much causes hepatic veno-occlusive disease, so therapeutic drug monitoring with dose adjustment is standard in many centres. Seizures are a recognised risk at conditioning doses, so prophylactic anticonvulsants are given. Pulmonary fibrosis, prolonged myelosuppression and infertility are expected consequences.

Sourcing notes. The injection is diluted in a specific solvent system containing DMA and polyethylene glycol, which is incompatible with polycarbonate components — filters, syringes and connectors must be compatible or they crack. A cytotoxic requiring full containment. Transplant units are the buyers, and demand follows transplant volume.

Busulfan — third party manufacturing & bulk supply

Busulfan 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.

Indicative minimum order quantity

Busulfan is supplied as Injection, tablets — supplied in more than one dosage form, each with its own manufacturing economics, so the indicative MOQ is a minimum order value of USD 5,000 per product. 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 Busulfan listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

Busulfan is listed as Injection, tablets in Injection 6 mg/mL (60 mg/10 mL); tablets 2 mg. Further strengths and pack presentations are confirmed with the manufacturer at RFQ stage.

Busulfan is referenced against Myleran, Busulfex (US). Reference brands are shown for identification only and remain the property of their respective trademark owners.