Trametinib Dimethyl Sulfoxide API Suppliers & Bulk Manufacturers
Available Forms: API (drug substance)
Available Strengths: USP grade or in-house specification
Reference Brands: Mekinist
Category: Active Pharmaceutical Ingredient
Trametinib dimethyl sulfoxide is the solvate form of the MEK inhibitor used in BRAF-mutant cancers. Generic developers, CDMOs and research groups source it.
Manufacture or export Trametinib Dimethyl Sulfoxide API? List it or send an offer →
Product Description:
Trametinib is a reversible inhibitor of MEK1 and MEK2, enzymes in the MAPK signalling pathway that drives many BRAF-mutant tumours. It is approved for BRAF V600E or V600K melanoma, alone or with dabrafenib, and with dabrafenib for adjuvant melanoma treatment, BRAF V600E non-small cell lung cancer, anaplastic thyroid cancer, other BRAF V600E solid tumours and paediatric low-grade glioma (reference brand: Mekinist).
Specification at a glance
| Traded form | 1:1 dimethyl sulfoxide solvate; free trametinib CAS 871700-17-3. |
|---|---|
| CAS number | 1187431-43-1 |
| Molecular formula | C26H23FIN5O4 · C2H6OS |
| Molecular weight | 693.53 g/mol (solvate); 615.40 g/mol free trametinib |
| Pharmacopoeia | No official monograph found; USP listed trametinib as a priority new monograph in 2024 (status unverified). Otherwise supplied to an in-house specification. |
Regulatory files and timing
The FDA list of Drug Master Files (third quarter 2026) shows 10 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 (Nov 2027 (compound patent + paediatric)). European Union: No confirmed date.
Handling and quality points
Trametinib is active at very low doses, so expect high-containment handling and ask for the maker's exposure band and cleaning limits. The DMSO sits in the crystal lattice, so specify it as a solvate content rather than only as a residual solvent, and watch for loss of solvate on drying or milling. Ask for photostability and moisture data, residual solvent results and a nitrosamine risk assessment.
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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.
Trametinib Dimethyl Sulfoxide API — third party manufacturing & bulk supply
Trametinib Dimethyl Sulfoxide 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
Trametinib Dimethyl Sulfoxide 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 Trametinib Dimethyl Sulfoxide API listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.
Request a quote for Trametinib Dimethyl Sulfoxide API →Usually answered within 48 hours, with matched manufacturers, indicative prices and document status.
Frequently Asked Questions
Ask for a GMP certificate, the specification and a recent CoA, and a US DMF letter of access or EU ASMF if you plan to file. Stability data on the solvate, an impurity profile, a nitrosamine risk assessment and containment details for this highly potent API are usually requested too.
The 1:1 DMSO solvate is the crystalline form described in the reference tablet label, and its properties are well characterised. Because the solvent is part of the crystal, DMSO content is a quality attribute and desolvation can change the form, so ask for XRPD and thermal data and stability results for the solvate.
Yes. PharmaTradz introduces licensed manufacturers, CDMOs and R&D teams to GMP-compliant trametinib makers after a first document check. Your identity is kept confidential until both parties are ready to go ahead.
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