Cabozantinib S-Malate API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

Available Strengths: USP grade or in-house specification

Reference Brands: Cabometyx, Cometriq

Category: Active Pharmaceutical Ingredient

Cabozantinib S-malate is an oral multi-kinase inhibitor used in kidney, liver, thyroid and neuroendocrine cancers. It is sourced by oncology formulators, CDMOs and licensed importers.

Product Description:

Cabozantinib inhibits several receptor tyrosine kinases involved in tumour growth and blood vessel formation, including MET, VEGFR2, AXL and RET. As tablets it is approved for advanced renal cell carcinoma (alone, or first-line with nivolumab), hepatocellular carcinoma after sorafenib, radioactive iodine-refractory differentiated thyroid cancer after VEGFR-targeted therapy, and previously treated well-differentiated neuroendocrine tumours (reference brand: Cabometyx). A capsule form is approved for progressive metastatic medullary thyroid cancer (reference brand: Cometriq).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 16 active Type II API DMFs for this molecule. There is a fair choice of sources, so compare documents and impurity profiles, not just price. 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: Entry expected (Jan 2031 (settlements)). European Union: No confirmed date.

Handling and quality points

Cabozantinib is a potent oncology API and is normally handled under high-potency controls. The salt is specifically the (S)-malate, so the specification should cover salt stoichiometry and the enantiomeric identity of the malic acid, and the crystal form should be confirmed by XRPD, as more than one form of the salt has been described. Very low aqueous solubility makes particle size a dissolution-relevant attribute, and a nitrosamine risk assessment should be part of the standard package.

Send an API enquiry All specialty APIs

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.