Dabrafenib Mesylate API Suppliers & Bulk Manufacturers
Available Forms: API (drug substance)
Available Strengths: Supplied to an in-house or pharmacopoeial specification
Reference Brands: Tafinlar, Finlee
Category: Active Pharmaceutical Ingredient
Dabrafenib mesylate is an oral BRAF kinase inhibitor used, often with trametinib, in several BRAF V600-mutated cancers. It is sourced by formulators, CDMOs and R&D teams.
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Product Description:
Dabrafenib is a kinase inhibitor of mutated BRAF, a protein behind uncontrolled growth in some tumours. It is approved alone for BRAF V600E-mutated unresectable or metastatic melanoma, and with trametinib for BRAF V600E or V600K melanoma (including adjuvant treatment after surgery), BRAF V600E-mutated metastatic non-small cell lung cancer, anaplastic thyroid cancer and other BRAF V600E solid tumours that have progressed after earlier treatment. A paediatric formulation is also approved, with trametinib, for BRAF V600E low-grade glioma (reference brands: Tafinlar, Finlee).
Specification at a glance
| Traded form | Methanesulfonate salt; white to slightly coloured solid, very slightly soluble at pH 1 and practically insoluble above pH 4 |
|---|---|
| CAS number | 1195768-06-9 (mesylate) |
| Molecular formula | C23H20F3N5O2S2·CH4O3S |
| Molecular weight | 615.68 g/mol (mesylate); 519.6 g/mol (free base) |
| Pharmacopoeia | No USP monograph yet: USP's small-molecule priority list (April 2024) names dabrafenib as a candidate for a new monograph. No Ph. Eur., JP, BP or IP monograph found (unverified). Supplied to an in-house specification. |
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: Patent expiry; entry not confirmed (Jan 2030). European Union: No confirmed date.
Handling and quality points
Confirm the mesylate salt and its crystal form, because the free base and other salts dissolve differently and are not interchangeable in a filing. Solubility falls away above pH 4, which makes particle size a key specification for capsules and dispersible tablets. As a potent anticancer kinase inhibitor it is normally handled under containment, and a mesylate salt calls for an assessment of alkyl methanesulfonate (sulfonate ester) impurities alongside the nitrosamine review.
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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.
Dabrafenib Mesylate API — third party manufacturing & bulk supply
Dabrafenib Mesylate API is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:
Indicative minimum order quantity
Dabrafenib Mesylate API is supplied as API (drug substance) — a dosage form priced by order value, so the indicative MOQ is a minimum order value of USD 5,000 per product. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.
Manufacturers of Dabrafenib Mesylate API listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.
Request a quote for Dabrafenib Mesylate API →Usually answered within 48 hours, with matched manufacturers, indicative prices and document status.
Frequently Asked Questions
Start with the GMP certificate, certificate of analysis and specification, and a US DMF letter of access or EU ASMF for filing. Because it is a mesylate salt, ask for the sulfonate ester risk assessment and test data, as well as a nitrosamine assessment. Salt and solid-form characterisation and stability data complete the usual list.
Methyl, ethyl or isopropyl methanesulfonate can form if methanesulfonic acid meets alcohol solvents during salt formation, and these are potentially mutagenic. Suppliers should explain how the process avoids or purges them and show test results against ICH M7-based limits.
Yes. PharmaTradz links licensed manufacturers, CDMOs and R&D teams with GMP-compliant makers of dabrafenib mesylate, and we check the documents up front. Your enquiry details stay private until both sides agree to connect.
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