Bosutinib Monohydrate API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

Available Strengths: USP grade or in-house specification

Reference Brands: Bosulif

Category: Active Pharmaceutical Ingredient

Bosutinib monohydrate is a BCR-ABL and Src kinase inhibitor used in Philadelphia chromosome-positive CML. Generic developers, CDMOs and R&D teams source the API.

Product Description:

Bosutinib is a tyrosine kinase inhibitor that blocks the BCR-ABL fusion kinase and Src-family kinases. It is approved for Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase, both newly diagnosed and after resistance or intolerance to prior therapy, and for accelerated or blast phase disease in adults with resistance or intolerance to prior therapy (reference brand: Bosulif).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 7 active Type II API DMFs for this molecule. Few filings usually means few qualified sources, so early contact with suppliers pays off. For Europe, ask whether the supplier holds a CEP or an EU ASMF and, for imports into the EU, a written confirmation.

Generic or biosimilar entry. United States: Generics/biosimilars on the market (Jun 2026). European Union: No confirmed date.

Handling and quality points

Bosutinib is usually handled as a potent kinase inhibitor in contained areas. The monohydrate is controlled as a single polymorph, so water content and XRPD should both be in the specification and checked after drying. The N-methylpiperazine side chain means the nitrosamine risk assessment should cover N-nitroso-N-methylpiperazine and related species.

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Brand names are trademarks of their respective owners and identify the reference medicine only. Information is general and was checked in October 2026; confirm specifications and filings with the supplier before purchase.