Lenvatinib Mesylate API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

Available Strengths: USP grade or in-house specification

Reference Brands: Lenvima, Kisplyx

Category: Active Pharmaceutical Ingredient

Lenvatinib mesylate is a multi-target kinase inhibitor used in thyroid, kidney, liver and endometrial cancers. Generic developers, CDMOs and R&D teams source the API.

Product Description:

Lenvatinib blocks several receptor tyrosine kinases involved in tumour blood vessel growth and cell signalling, including VEGFR1-3, FGFR1-4, PDGFR alpha, KIT and RET. It is approved for radioactive iodine-refractory differentiated thyroid cancer, advanced renal cell carcinoma (with pembrolizumab or everolimus), unresectable hepatocellular carcinoma and, with pembrolizumab, certain advanced endometrial carcinomas (reference brand: Lenvima, Kisplyx).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 14 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 (Jul 2030 (settlements)). European Union: Patent expiry; entry not confirmed (2027).

Handling and quality points

Lenvatinib is usually treated as a high-potency API, with contained handling and dedicated or well-validated cleaning on shared equipment. Because it is a mesylate, the supplier should show control of alkyl methanesulfonate esters, which are potential mutagens, wherever alcohols are present during salt formation, alongside a nitrosamine risk assessment. Several crystalline forms have been reported, so agree the form and test it by XRPD.

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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.