Encorafenib API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

Available Strengths: Supplied to an in-house or pharmacopoeial specification

Reference Brands: Braftovi

Category: Active Pharmaceutical Ingredient

Encorafenib is an oral BRAF kinase inhibitor used with other targeted drugs in melanoma, colorectal and lung cancer. It is sourced by formulators, CDMOs and research teams.

Product Description:

Encorafenib is a kinase inhibitor that targets mutated BRAF, a protein that drives uncontrolled cell growth in some tumours. It is approved with binimetinib for BRAF V600E or V600K-mutated unresectable or metastatic melanoma and for BRAF V600E-mutated metastatic non-small cell lung cancer, and with cetuximab, with or without fluorouracil-based chemotherapy, for BRAF V600E-mutated metastatic colorectal cancer (reference brand: Braftovi).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 3 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 (2030 (2031 with pending PTE)). European Union: No confirmed date.

Handling and quality points

Encorafenib's solubility drops sharply as pH rises, so particle size and solid form should be agreed with the formulator because both affect dissolution. The molecule has one stereocentre in its side chain, so chiral purity belongs in the specification. Treat it as a potent anticancer compound and expect suppliers to provide containment and cleaning data, together with nitrosamine and mutagenic impurity assessments.

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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.