Tucatinib API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

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

Reference Brands: Tukysa

Category: Active Pharmaceutical Ingredient

Tucatinib is a HER2-selective oral kinase inhibitor for HER2-positive breast and colorectal cancer. It is sourced by oncology formulators, CDMOs and licensed importers.

Product Description:

Tucatinib is a reversible tyrosine kinase inhibitor that is highly selective for HER2 over EGFR, blocking growth signals in HER2-positive cancer cells. In the US it is approved with trastuzumab and capecitabine for advanced or metastatic HER2-positive breast cancer, including patients with brain metastases, after at least one prior anti-HER2 regimen in the metastatic setting, and with trastuzumab for RAS wild-type, HER2-positive metastatic colorectal cancer after standard chemotherapy (reference brand: Tukysa).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 8 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 (2031 (2034 with pending PTE)). European Union: Patent expiry; entry not confirmed (2031).

Handling and quality points

Tucatinib is a potent oncology API and is usually handled under high-potency controls. The reference tablet contains copovidone, a polymer often used in amorphous solid dispersions, so agree the solid form and particle properties you need with your formulator before you approach suppliers. The finished product must be kept dry, so ask for moisture-sorption data on the drug substance and pack it with suitable moisture protection.

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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.