Exatecan API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

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

Reference Brands: Enhertu, Datroway

Category: Active Pharmaceutical Ingredient

Exatecan is a highly potent camptothecin-type topoisomerase I inhibitor used in ADC research and payload-linker chemistry. It is sourced by ADC developers, CDMOs and research teams.

Product Description:

Exatecan is a synthetic, water-soluble camptothecin analogue that inhibits topoisomerase I, causing DNA strand breaks in dividing cells. It has not been approved as a medicine in its own right, but it is the parent structure of DXd, the topoisomerase I inhibitor payload in the approved antibody-drug conjugates trastuzumab deruxtecan and datopotamab deruxtecan, which are used in certain breast, lung and gastric cancers (reference brands: Enhertu, Datroway).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 11 active Type II API DMFs for this molecule. There is a fair choice of sources, so compare documents and impurity profiles, not just price. 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: No confirmed date. European Union: No confirmed date.

Handling and quality points

Exatecan is extremely potent and should only come from sites with dedicated high-containment suites, isolator handling and validated cleaning. Like other camptothecins, its lactone ring can open to the carboxylate form in neutral or basic conditions, so ask how the supplier controls this, along with chiral purity at its two stereocentres. It is generally stored cold, dry and protected from light, and shipped in sealed secondary containment with full hazard labelling.

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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.