Last updated: April 22, 2026
Who supplies vorasidenib API (active pharmaceutical ingredient)?
Vorasidenib is manufactured to support branded supply chains for VORASIDENIB (UK/US: manufacturing and supply for AG-881-derived program). Public disclosures tie commercial supply to large CDMO and API manufacturing networks used for targeted oncology oral small molecules. Supplier identification at the named-company level requires patent prosecution records, drug master file access, and regulatory inspection detail; those are not present in the provided prompt.
Result: No complete, verifiable supplier list can be produced from the information available in this request alone.
Who manufactures vorasidenib drug product (tablets/capsules) and packages it?
Vorasidenib is marketed as an oral targeted therapy. Drug product manufacturing typically involves a CDMO or branded-manufacturer network capable of high-potency oncology solids, with packaging and labeling performed under GMP. Named, confirmable manufacturers are not derivable from the prompt content.
Result: No complete, verifiable supplier list can be produced from the information available in this request alone.
What filings identify vorasidenib supply-chain suppliers (and where do they appear)?
Supplier names for APIs and finished dosage forms usually surface through:
- US FDA approvals and inspection outcomes (facility-level information tied to NDA/ANDA supplements),
- European Medicines Agency (EMA) EPAR/Annex documents (manufacturing site disclosure),
- Patent family assignments and prosecution exhibits (listing of contractors),
- DMF holder and referencing documents (API supplier identity),
- US patent “manufacturing by” disclosures for drug substance and intermediate steps.
The provided prompt includes none of these documents.
Result: No complete, accurate, supplier-by-supplier mapping is possible.
Commercial procurement view: what you can do without supplier names
Even without named suppliers, procurement teams typically structure sourcing around these controllables for vorasidenib oral oncology solids:
| Supply-chain layer |
What procurement verifies |
Typical documentation artifact |
| API |
GMP status, impurity profile control, particle size/spec, salt form control, residual solvents |
CoA specs, GMP certificate, CMC module excerpts, DMF reference statements |
| Intermediates |
Step yield and impurity control at each stage |
Synthetic route paragraphs, impurity listings in CMC |
| Finished dose |
Blend uniformity, dissolution, stability program, container closure compatibility |
Finished product CoA, stability protocols, validation summaries |
| Packaging/labeling |
Child-resistant packaging, serialized labeling requirements (if applicable), artwork controls |
Batch packaging record extracts, labeling release procedures |
This framework helps contract without vendor names, but it does not name suppliers.
Key Takeaways
- A named supplier list cannot be produced from the information provided in this request.
- Vorasidenib supply is usually split across API manufacturing, drug product manufacturing, and packaging/labeling under GMP oncology solids controls.
- Supplier identification requires regulatory documents (US FDA/EMA), DMF references, or patent prosecution exhibits, none of which are included here.
FAQs
-
Are vorasidenib API suppliers the same as drug-product manufacturers?
Not usually. API and finished-dose manufacturing are commonly split between different GMP sites.
-
Where do vorasidenib suppliers typically appear publicly?
US approval packages, EMA manufacturing site annexes, DMF references, and patent prosecution materials.
-
Do patents list the exact API manufacturer?
Sometimes, especially in prosecution histories and contractor attribution, but not consistently.
-
What level of detail is needed to “name” a supplier confidently?
Facility-level identification tied to a regulatory filing, inspection record, or DMF reference.
-
Can a procurement strategy proceed without named suppliers?
Yes, using qualification criteria (GMP, specs, impurity control, stability) before vendor nomination.
References
[1] FDA. “Drug Approvals and Databases.” U.S. Food and Drug Administration. (Regulatory entry points for manufacturing site disclosures.) https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
[2] EMA. “European public assessment reports (EPAR): document library.” European Medicines Agency. (Manufacturing and distribution site disclosures in EPAR/annexes.) https://www.ema.europa.eu/en/medicines
[3] USP. “Drug Master Files (DMF): overview.” United States Pharmacopeia (background on DMF structure used to identify API sources). https://www.usp.org
