Binimetinib API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

Available Strengths: USP grade or in-house specification

Reference Brands: Mektovi

Category: Active Pharmaceutical Ingredient

Binimetinib is an oral MEK1/2 inhibitor used with encorafenib in BRAF-mutant melanoma and lung cancer. It is sourced by generic developers, CDMOs and R&D teams.

Product Description:

Binimetinib is a reversible inhibitor of MEK1 and MEK2 in the MAPK signalling pathway. It is approved in combination with encorafenib for unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, and for metastatic non-small cell lung cancer with a BRAF V600E mutation (reference brand: Mektovi).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 6 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: Patent expiry; entry not confirmed (Mar 2027 (Aug 2027 if PTE granted)). European Union: No confirmed date.

Handling and quality points

Binimetinib is generally treated as a potent kinase inhibitor and handled in contained areas. The label describes it as slightly soluble at pH 1 and practically insoluble from pH 4.5 upwards, so particle size and solid form deserve early agreement because they affect tablet dissolution. Ask for the impurity profile, residual solvent data and a nitrosamine risk assessment.

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.