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Suppliers and packagers for generic pharmaceutical drug: Trabectedin
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Trabectedin
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 |
Trabectedin suppliers: who manufactures the drug substance and commercial product, and what supply risks matter
Trabectedin is a niche oncology active with tightly controlled manufacturing. Commercial supply in most markets is run through branded-product manufacturers and contracted fill-finish or drug-substance suppliers under license chains from the original developer. In practice, “supplier” lists for trabectedin are not stable by public catalog because the same entity may appear as (1) MAH/marketer, (2) contract manufacturer for drug substance, or (3) contract manufacturer for sterile drug-product manufacturing, with different names across jurisdictions and label changes.
Because trabectedin supply is highly dependent on jurisdiction, label, dosage form, and the specific product brand (for example, the branded injection vs. any later reformulations), a complete, accurate “suppliers” map cannot be produced without specific product identifiers and territory scope.
What companies supply trabectedin injection in the US and EU?
Featured answer: Trabectedin supply is dominated by the branded product holders and their contract manufacturing partners, rather than a broad panel of interchangeable API vendors. Public procurement and listing pages often show only the branded product manufacturer and packager, not the full API supply chain.
Which branded trabectedin products define the supplier list?
- Brand-to-brand differences drive which manufacturing site is relevant:
- Different packagers (EU vs. US) can change the “supplier” appearing on invoices and pharmacy distribution listings.
- Any change in fill-finish or label holder changes the listed manufacturer even if the API origin stays the same.
Why “supplier” can mean three different things
- Drug substance manufacturer (API)
- Sterile drug product manufacturer (fill-finish, aseptic processing, sterilization)
- Marketing authorization holder (MAH) / label owner (often a separate legal entity from manufacturing)
A correct supplier roster must be mapped to the exact form and label used in the target market.
Which suppliers provide trabectedin drug substance (API) versus sterile drug product?
Featured answer: Trabectedin API and the sterile injection are typically produced by different specialized sites under controlled quality systems; the API supplier is not always disclosed in public-facing drug catalogs.
Drug substance supply chain signals to check
- Site ownership or contract manufacturing arrangements tied to regulatory submissions
- GMP batch release location vs. marketed product site
- Consistency of impurity profile across lots, which indicates the same upstream API route
Sterile drug product supply chain signals to check
- Aseptic processing and sterilization method
- Fill-finish sponsor site (the site named for product manufacture in regulatory dossiers)
- Packaging and labeling release site (varies by country)
How do procurement and tender listings label trabectedin suppliers?
Featured answer: Procurement systems often label the “supplier” as the finished-goods vendor or packager, not the underlying API manufacturer.
Typical listing patterns
- Distributor or wholesaler name appears as the “supplier” for purchase orders
- Finished-goods packager/manufacturer name appears on drug product listing pages
- API vendor rarely appears unless the tender explicitly requests API or unless the jurisdiction’s import documentation is publicly indexed
Implications for supply qualification
- Qualification must follow the actual chain of custody for the ordered SKU.
- API-only qualification does not ensure finished-goods supply continuity.
What supply risks exist for trabectedin (API scarcity, batch release, contract transitions)?
Featured answer: The main risks for trabectedin supply are batch-to-batch control at specialized sterile sites, limited qualified manufacturing capacity, and contract transitions that can move release sites.
Practical risk categories
- Limited number of GMP sterile fill-finish capacities for a cytotoxic oncology sterile injection
- Regulatory batch release timing and shipping lead times
- Transition risk if a contract manufacturer changes after inspections or supply shortages
What to monitor during sourcing
- Lot availability and distribution lead times by country
- Recalls or quality notices tied to specific manufacturing sites
- Stability or container-closure changes that force relabeling and new release
Which dosage forms and strengths change the supplier mapping for trabectedin?
Featured answer: Supplier mapping changes when the SKU changes (strength, vial size, presentation, or packaging).
Common SKU drivers
- Vial strength and pack size (affects which fill-finish line is used)
- Dilution or administration kit inclusion (sometimes ties to a different packaging line)
- Label language and NDC/NHRP/EMA package identifiers (country-specific)
Key Takeaways
- “Suppliers for trabectedin” must be defined by product SKU and geography because the listed supplier often changes with packager and MAH.
- Trabectedin supply is usually controlled through branded-product manufacturing and fill-finish partners, not a wide-open API vendor market.
- Supply-risk assessment should be built around sterile manufacturing and batch release continuity, not only API availability.
FAQs
1) Who is the MAH/label holder for trabectedin in major markets?
Publicly visible MAH names vary by jurisdiction and package. The MAH is the most reliable legal anchor for supplier mapping, but it still does not identify the API site.
2) Are there multiple API suppliers for trabectedin?
Often not in a way that is transparent publicly. Supply tends to be concentrated among a small number of controlled API manufacturers and qualified contract chains.
3) Can I source trabectedin API directly instead of the finished injection?
That depends on regulatory authorization for purchase and handling of cytotoxic APIs, plus market access rules for the specific region.
4) What determines whether a new supplier can qualify for trabectedin sourcing?
Qualified supplier acceptance depends on chain-of-custody, GMP compliance of the specific manufacturing site(s), and product equivalence for the target SKU.
5) How can I validate the true manufacturer for a trabectedin lot?
Validate from lot documentation tied to the ordered SKU: the labeled finished-goods manufacturer/packager on the carton and the manufacturing site shown in the batch documentation.
References
- (No sources were provided in the prompt, and no verifiable public supplier list for trabectedin by SKU and jurisdiction can be cited without additional input.)
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