Ixabepilone API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

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

Reference Brands: Ixempra

Category: Active Pharmaceutical Ingredient

Ixabepilone is a semi-synthetic epothilone B analogue used in advanced breast cancer. This cytotoxic API is sourced by injectable formulators, CDMOs and research teams.

Product Description:

Ixabepilone is a semi-synthetic analogue of epothilone B that stabilises microtubules and stops cancer cells dividing. In the US it is approved with capecitabine, or alone, for metastatic or locally advanced breast cancer that has stopped responding to earlier treatment with anthracyclines and taxanes and, for use alone, capecitabine (reference brand: Ixempra).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 1 active Type II API DMF 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: No confirmed date. European Union: No confirmed date.

Handling and quality points

Ixabepilone is a cytotoxic and must be handled in high containment with dedicated or fully validated equipment. The starting epothilone comes from fermentation, so the impurity profile can carry fermentation-related analogues as well as synthesis by-products. The reference kit is stored refrigerated and protected from light, so ask the supplier for API storage conditions, photostability data and temperature-controlled shipping.

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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.