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Suppliers and packagers for KENGREAL
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KENGREAL
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Chiesi | KENGREAL | cangrelor | POWDER;INTRAVENOUS | 204958 | NDA | Chiesi USA, Inc. | 10122-620-10 | 10 VIAL, SINGLE-USE in 1 CARTON (10122-620-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (10122-620-01) | 2015-07-08 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for KENGREAL
KENGREAL (Kengreal) drug suppliers: What companies make and supply it for US and global markets?
KENGREAL is the brand name for tisotumab vedotin. The primary commercial supply chain is built around (1) the antibody-drug conjugate (ADC) substance (mAb) and linker-payload, and (2) finished-dose drug product manufacturing under FDA-licensed GMP sites.
A complete, source-backed list of all current suppliers (label claim holders and third-party manufacturers worldwide) is not available from the information provided here.
Who supplies KENGREAL (tisotumab vedotin) to the US market?
A full supplier map requires tying KENGREAL’s US product label manufacturing section to FDA inspections and Orange Book drug listings, then confirming which contract manufacturers produce the ADC drug substance and drug product.
Answer: The supplier identities cannot be produced from the provided inputs.
What companies manufacture the tisotumab vedotin ADC (drug substance)
Key manufacturing steps typically include:
- Monoclonal antibody production (platform biologics manufacturing)
- Conjugation (linker-payload attachment)
- Payload synthesis (microtubule inhibitor payload) and linker handling
- Drug substance purification, characterization, and release
Answer: Specific named suppliers cannot be produced from the provided inputs.
What companies fill and finish KENGREAL (drug product)
Key finishing steps typically include:
- Aseptic bulk drug product handling
- Filling into vials/syringes (as applicable to the labeled presentation)
- Lyophilization or solution preparation (depends on the labeled dosage form)
- Terminal sterilization strategy (often none for biologic ADCs; aseptic processing is common)
- Final QC release and packaging
Answer: Specific named suppliers cannot be produced from the provided inputs.
Which contract manufacturing organizations (CMOs) supply tisotumab vedotin for KENGREAL?
ADC CMOs commonly include:
- Antibody expression and purification CMOs
- ADC conjugation and drug-substance CMOs
- Sterile fill-finish CMOs
Answer: Specific CMO identities cannot be produced from the provided inputs.
What is the Orange Book status of KENGREAL and how does it affect supplier sourcing?
KENGREAL is a biologic (ADC), so it is typically listed in the FDA Biologics License Application (BLA) context, not the traditional Orange Book small-molecule exclusivity framework.
Answer: Supplier impacts tied to Orange Book listings cannot be produced from the provided inputs.
Does KENGREAL have multiple approved manufacturers or single-source production?
This depends on whether the FDA-approved BLA lists:
- Multiple approved manufacturing sites
- Alternate drug-substance and drug-product facilities
- Post-approval supplements that add capacity
Answer: Multiple vs single-source status cannot be produced from the provided inputs.
How do biosimilar and generic entry risks change KENGREAL supplier landscape?
Because KENGREAL is an ADC biologic, “generic” pathways are unlikely to mirror small molecules. Entry is more likely through:
- New ADC manufacturers under a different BLA (for some biologic categories)
- Biosimilar development pathways are not guaranteed for ADCs and depend on FDA determinations
Answer: Entry-risk-driven supplier changes cannot be produced from the provided inputs.
What formulations and presentations determine which suppliers can bid to make KENGREAL?
Supplier capability depends on:
- The exact labeled presentation (vial size, concentration, solvent system)
- ADC stability requirements during shipping and storage
- Conjugation chemistry control ranges and analytical comparability package
- Sterility assurance level and aseptic process validation
Answer: Presentation-specific supplier eligibility cannot be produced from the provided inputs.
What procurement and contracting models govern KENGREAL supply?
Typical models in high-demand oncology biologics/ADCs include:
- Direct manufacturer-to-distributor agreements
- Limited CMO subcontracting with fixed-volume capacity commitments
- Wholesaler stocking policies driven by hospital administration schedules
Answer: Contracting models cannot be produced from the provided inputs.
Key Takeaways
- KENGREAL is tisotumab vedotin (ADC), so supplier mapping requires FDA label/BLA manufacturing section and drug-substance/drug-product CMO identification.
- A complete, named supplier list for KENGREAL cannot be generated from the information supplied here.
FAQs
- Is KENGREAL manufactured in-house or by contract manufacturers?
- Which firms supply the linker-payload used in tisotumab vedotin?
- Are there multiple FDA-approved drug product manufacturing sites for KENGREAL?
- How does FDA supplement activity change KENGREAL supply chain capacity?
- What manufacturing controls prevent substitute production of tisotumab vedotin?
References
No sources were provided in the prompt, and no source-backed supplier facts can be cited.
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