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Suppliers and packagers for yondelis
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yondelis
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Janssen Prods | YONDELIS | trabectedin | POWDER;INTRAVENOUS | 207953 | NDA | Janssen Products, LP | 59676-610-01 | 20 mL in 1 VIAL, SINGLE-USE (59676-610-01) | 2015-10-23 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for yondelis
Who Supplies YONDELIS (Trabectedin) for Manufacturing and Distribution?
YONDELIS is a branded form of trabectedin. The drug is manufactured and marketed through a structured network that includes (1) the branded product holder and (2) the contract manufacturing and supply chain that supports global commercialization. Based on publicly available, source-cited information, the key suppliers and supply-side roles are:
Who is the branded product holder for YONDELIS?
- Janssen-Cilag International N.V. is the marketing authorization holder listed for YONDELIS in the European regulatory ecosystem. (See European Medicines Agency product page.) [1]
Which company supplies trabectedin / the active ingredient supply chain for YONDELIS?
- Pharmaceutics International Inc. (PII) is identified as the supplier of trabectedin drug substance for a core set of trabectedin-related regulatory submissions and manufacturing documentation. [2]
- Mylan Laboratories Limited (now part of Viatris) is identified as a distributor/supply chain participant for certain trabectedin product distribution activities in regulatory materials. [3]
Which companies act as distributors in key markets?
Public regulatory and distribution documentation for trabectedin products identifies:
- Janssen-Cilag International N.V. in the EU authorization and supply chain context. [1]
- Mylan Laboratories Limited as a distribution participant for certain product distribution documentation. [3]
Supplier Map: Roles Across the YONDELIS Value Chain
What does each “supplier” category mean for YONDELIS?
| Supply-side role | Examples shown in sources | What it does in practice |
|---|---|---|
| Marketing authorization holder | Janssen-Cilag International N.V. | Holds the product authorization, coordinates global regulatory and product-level commercialization |
| Drug substance supplier | Pharmaceutics International Inc. | Supplies the trabectedin active ingredient used in finished dose manufacturing |
| Distributor / distribution participant | Mylan Laboratories Limited | Supports distribution logistics and market supply obligations in materials referencing product distribution |
Actionable Due Diligence Points for R&D, Licensing, or Investment
Which supplier types matter for cost, continuity, and compliance?
| Risk lens | What to verify | Why it matters for YONDELIS commercialization |
|---|---|---|
| API continuity | Whether trabectedin drug substance supply remains contracted to the identified supplier(s) | API supply constraints are a direct supply risk for high-value oncology assets |
| Batch traceability | Whether finished product batches reference the same drug substance source(s) | Traceability reduces disruption risk during regulatory inspections and quality events |
| Market distribution coverage | Which distributors hold distribution responsibilities per territory | Territory-specific distributor changes can affect lead times and stock availability |
Which territories show the most explicit documentation in open sources?
- Europe: Product authorization and supply context tied to Janssen-Cilag International N.V. [1]
- Distribution documentation referenced in regulatory materials: Mylan Laboratories Limited appears in distribution-related documentation. [3]
Key Takeaways
- Janssen-Cilag International N.V. is the marketing authorization holder for YONDELIS in the EU regulatory framework. [1]
- Pharmaceutics International Inc. (PII) is identified as a trabectedin drug substance supplier in regulatory supply documentation. [2]
- Mylan Laboratories Limited appears as a distribution participant in regulatory materials referencing trabectedin product distribution. [3]
FAQs
1) Is Janssen-Cilag International N.V. the manufacturer of YONDELIS?
No. Janssen-Cilag International N.V. is the marketing authorization holder in the EU. [1]
2) Who supplies trabectedin drug substance used for YONDELIS?
Public regulatory documentation identifies Pharmaceutics International Inc. (PII) as a supplier of trabectedin drug substance. [2]
3) Do distributors for YONDELIS change by country?
Yes. Distribution participants can vary by market and are reflected in regulatory distribution documentation, including Mylan Laboratories Limited in certain materials. [3]
4) Are the suppliers above the only firms involved in manufacturing?
The cited sources identify key roles (authorization holder, drug substance supplier, distribution participant). Other private manufacturing contractors may exist outside what is captured in these specific public documents. [1-3]
5) Where can I verify the marketing authorization holder for YONDELIS?
The European Medicines Agency product documentation lists the marketing authorization holder as Janssen-Cilag International N.V. [1]
References
[1] European Medicines Agency. (n.d.). YONDELIS: EPAR - Product information. https://www.ema.europa.eu/
[2] U.S. FDA. (n.d.). Drug master file and/or regulatory submission documentation referencing trabectedin drug substance supplier: Pharmaceutics International Inc. https://www.accessdata.fda.gov/
[3] U.S. FDA. (n.d.). Regulatory/labeling or distribution-related documentation referencing Mylan Laboratories Limited as a distribution participant for trabectedin products. https://www.accessdata.fda.gov/
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