Axitinib API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

Available Strengths: USP grade or in-house specification

Reference Brands: Inlyta

Category: Active Pharmaceutical Ingredient

Axitinib is an oral VEGF receptor tyrosine kinase inhibitor used in advanced kidney cancer. It is sourced by generic formulators, CDMOs and R&D teams.

Product Description:

Axitinib is a tyrosine kinase inhibitor that blocks VEGF receptors 1, 2 and 3, cutting off the signals tumours use to grow new blood vessels. It is approved for advanced renal cell carcinoma, as first-line treatment together with pembrolizumab or avelumab, and on its own after failure of one prior systemic therapy (reference brand: Inlyta).

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: No confirmed date. European Union: No confirmed date.

Handling and quality points

Axitinib is known for extensive polymorphism, so the crystal form must be defined by XRPD, shown to be stable on storage and matched to the form used in your formulation and filing. Its aqueous solubility is very low across the physiological pH range, which makes particle size a key specification. It is a potent anticancer kinase inhibitor normally handled under containment, and because the vinylpyridine group is the (E)-isomer, E/Z isomer control should be in the specification.

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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.