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Cabazitaxel API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

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

Reference Brands: Jevtana

Category: Active Pharmaceutical Ingredient

Cabazitaxel is a semi-synthetic taxane used in metastatic castration-resistant prostate cancer. Injectable formulators, CDMOs and research teams source this cytotoxic API.

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Product Description:

Cabazitaxel is a semi-synthetic taxane that binds tubulin, stabilises microtubules and blocks cell division, and it is less affected by some drug-efflux resistance mechanisms than older taxanes. It is approved with prednisone for metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing regimen (reference brand: Jevtana).

Specification at a glance

Traded formTraded as the solvent-free form or as the 1:1 acetone solvate (C45H57NO14 · C3H6O) described for the reference product.
CAS number183133-96-2
Molecular formulaC45H57NO14
Molecular weight835.93 g/mol (anhydrous); 894.01 g/mol acetone solvate
PharmacopoeiaPh. Eur.: Cabazitaxel acetone (3060) adopted March 2023 and Cabazitaxel (3223) adopted at the 183rd Commission session. USP, JP and IP status unverified.

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 18 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: Patent expiry; entry not confirmed (Oct 2030). European Union: No confirmed date (generic authorised Aug 2020).

Handling and quality points

Cabazitaxel is a cytotoxic and needs high containment, dedicated or validated equipment and careful cleaning verification. Decide early whether you need the acetone solvate or the solvent-free form, because they now have separate Ph. Eur. monographs and differ in residual solvent and solid-state testing. Semi-synthesis from a yew-derived starting material (10-deacetylbaccatin III) brings taxane-related impurities that the specification must cover.

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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.

Cabazitaxel API — third party manufacturing & bulk supply

Cabazitaxel 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:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.
Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.
Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Cabazitaxel 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 Cabazitaxel API listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

Start with the GMP certificate, specification and CoA. With Ph. Eur. monographs now in place, a CEP may be available where the maker holds one; otherwise ask for an EU ASMF or US DMF letter of access, together with stability data, a nitrosamine assessment and containment information.

The reference concentrate is described with the acetone solvate, and Ph. Eur. now has monographs for both cabazitaxel and cabazitaxel acetone. Either can work, but the choice fixes the monograph, the acetone limit and the solid-state data you need, so align it with your formulation and filing plans.

Yes. We connect licensed manufacturers, CDMOs and R&D teams with GMP-compliant cabazitaxel makers and look at their documents before any introduction. Your details remain private until both sides are happy to proceed.

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