Trabectedin API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

Available Strengths: USP grade or in-house specification

Reference Brands: Yondelis

Category: Active Pharmaceutical Ingredient

Trabectedin is a highly potent, marine-derived cytotoxic made by a long semi-synthetic route. It is sourced by oncology injectable manufacturers, CDMOs and R&D teams.

Product Description:

Trabectedin is an alkylating agent first isolated from the sea squirt Ecteinascidia turbinata; it binds in the minor groove of DNA and interferes with transcription and DNA repair, which leads to tumour cell death. In the US it is approved for unresectable or metastatic liposarcoma or leiomyosarcoma after a prior anthracycline-containing regimen. In the EU it is approved for advanced soft tissue sarcoma after anthracyclines and ifosfamide, or where these are unsuitable, and with pegylated liposomal doxorubicin for relapsed platinum-sensitive ovarian cancer (reference brand: Yondelis).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 7 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 (Jan 2028). European Union: No confirmed date (generic authorised Apr 2025).

Handling and quality points

Trabectedin is active at very low exposure levels, so it is handled in the highest containment band, normally in isolators within dedicated or strictly segregated suites with validated cleaning and deactivation. Batches are small and the molecule is sensitive to heat and light, so expect cold storage, light protection and temperature-controlled shipping. Analytical precision matters: assay and related-substance methods have to work well at the low quantities used in the finished lyophilised product.

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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.