Lurbinectedin API Suppliers & Bulk Manufacturers
Available Forms: API (drug substance)
Available Strengths: Supplied to an in-house or pharmacopoeial specification
Reference Brands: Zepzelca
Category: Active Pharmaceutical Ingredient
Lurbinectedin is a highly cytotoxic alkylating agent made by a long, complex synthesis. It is sourced by oncology injectable developers, CDMOs and research teams.
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Product Description:
Lurbinectedin is a synthetic alkylating agent, structurally related to the marine-derived compound trabectedin, that binds in the minor groove of DNA and blocks the active transcription that tumour cells depend on. In the US it is approved for adults with metastatic small cell lung cancer that has progressed on or after platinum-based chemotherapy, and, with atezolizumab, as maintenance treatment of extensive-stage small cell lung cancer after first-line induction therapy (reference brand: Zepzelca).
Specification at a glance
| Traded form | Free base; the reference product is a lyophilised powder for intravenous use. |
|---|---|
| CAS number | 497871-47-3 |
| Molecular formula | C41H44N4O10S |
| Molecular weight | 784.9 g/mol |
| Pharmacopoeia | No pharmacopoeia monograph found; supplied to an in-house specification. |
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 (Dec 2029 (compound patent)). European Union: Protected beyond 2033 (2036 (regulatory protection, est.)).
Handling and quality points
Lurbinectedin is a hazardous, highly potent cytotoxic, so it should come from a site with dedicated or fully contained suites, validated cleaning and occupational exposure controls in the strictest bands. The synthesis is long, with several stereocentres, and the impurity profile, including stereoisomers and degradation products, is the main quality question. The finished product is kept refrigerated; agree drug substance storage and shipping temperatures against the supplier's stability data, and use packaging and transport set up for cytotoxic goods.
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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.
Lurbinectedin API — third party manufacturing & bulk supply
Lurbinectedin 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:
Indicative minimum order quantity
Lurbinectedin 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 Lurbinectedin API listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.
Request a quote for Lurbinectedin API →Usually answered within 48 hours, with matched manufacturers, indicative prices and document status.
Frequently Asked Questions
A GMP certificate that covers high-potency manufacture, the specification and a certificate of analysis, and a summary of the route with its stereochemical controls. For a filing, ask whether a US DMF exists and can be referenced by letter of access, and request stability data, a nitrosamine risk assessment and occupational exposure data so your own site can handle it safely.
It is treated as a highly potent cytotoxic, so expect isolator or closed-system handling and an occupational exposure limit at the very low end of the scale. Ask the supplier for its assigned exposure band and the toxicology behind it, because your weighing and compounding areas will need to match it.
We can. PharmaTradz links formulation companies, CDMOs and R&D groups with GMP-compliant makers of high-potency APIs, and we look over the supplier's documents first. Nobody sees your details until both parties are ready to go ahead.
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