Busulfan

As a bifunctional alkylating antineoplastic agent, busulfan covalently binds to the N7 position of guanine in DNA, causing intra-strand or inter-strand DNA cross-linking and blocking the processes of DNA replication and transcription. It is a cell cycle non-specific drug. Clinically, it is mainly used for remission therapy in the chronic phase of chronic myeloid leukemia, and can also be used as a medication for myeloablative conditioning regimens prior to hematopoietic stem cell transplantation, meeting the treatment needs of adults and children with hematological malignancies. It is one of the core basic medications for reducing transplant rejection and improving the long-term survival rate of patients.

According to publicly verifiable data, the global busulfan market size was approximately USD 120 million in 2023, with a compound annual growth rate maintained at around 3.2%. The growth momentum mainly comes from the steady increase in the number of hematopoietic stem cell transplantation surgeries and the rise in the popularization rate of hematological tumor diagnosis and treatment in developing countries. In terms of the Chinese market, the sales of busulfan preparations in public medical institutions were approximately RMB 180 million in 2023. Currently, the market is dominated by generic drug supplies. More than 8 domestic enterprises have obtained preparation approval documents, and this product has been included in the seventh batch of national centralized drug procurement. The winning bid price has dropped by approximately 68% compared with the original research price, and clinical accessibility has been significantly improved.

The original research enterprise of busulfan is GlaxoSmithKline, with the original brand name Myleran. Its core compound patent expired globally in 1983. At present, the mainstream dosage forms include 0.5mg and 2mg tablets, as well as 60mg/10ml injection. Both dosage forms have been included in the Chinese *Catalogue of Reference Preparations for Chemical Drugs*, and are also listed as reference preparations by the FDA. Up to now, the Center for Drug Evaluation of the National Medical Products Administration of China has publicized 12 registration entries of busulfan active pharmaceutical ingredients, 8 of which are in Status A and can be used in association with domestic preparation declarations. 11 busulfan preparation varieties have been approved for marketing in China. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of busulfan impurity reference standards. Most products are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for active pharmaceutical ingredient research and development, quality research and consistency evaluation processes.