Last updated: April 25, 2026
Who Supplies XOSPATA (Gilteritinib) and Its Key Build Blocks?
XOSPATA is gilteritinib, an oral targeted oncology drug. The commercial supply chain is anchored by the marketing authorization holder and manufacturing network used to produce and release finished drug product batches and active ingredient. Below is the supplier map used by the product’s regulatory filings and label disclosures.
Marketing authorization holder (U.S.) and commercial source
| Role |
Entity |
Where it appears |
| Marketing authorization holder / U.S. NDA owner |
Astellas Pharma US, Inc. |
XOSPATA U.S. Prescribing Information, distribution/manufacturer references on label |
Label-based distribution/manufacturing references show the product is sourced and released through Astellas’ global manufacturing network, with specific drug substance and drug product sites named in the product labeling. (Source: XOSPATA U.S. Prescribing Information.)
Finished drug product (tablet) manufacturing and release
XOSPATA is supplied as gilteritinib tablets. The U.S. labeling identifies the manufacturer of the finished dosage form (drug product) responsible for batch release.
| Role |
Supplier(s) named on label |
Drug form |
Evidence |
| Drug product manufacturer (finished tablets) |
Named manufacturers in XOSPATA U.S. Prescribing Information |
Tablets |
Label “Manufactured for” / “Manufactured by” sections (Source: XOSPATA U.S. Prescribing Information.) |
Drug substance (gilteritinib API) manufacturing
Drug substance is produced by the API manufacturing sites identified in the regulatory package and label. XOSPATA’s labeling ties the API to the same global network used for final drug product release.
| Role |
Supplier(s) named in regulatory/label materials |
Substance |
Evidence |
| Drug substance (API) manufacturer |
Named API manufacturing sites in XOSPATA regulatory/label materials |
Gilteritinib |
Label and regulatory submission references (Source: XOSPATA U.S. Prescribing Information.) |
What do the label disclosures say about “supply” and where it sits in the chain?
1) Finished tablets are controlled at release
XOSPATA is not a kit or compounded product. The supply model is standard for an approved oral oncology therapy: the tablet is manufactured at licensed facilities, then released into distribution under the NDA holder’s distribution controls (Source: XOSPATA U.S. Prescribing Information.).
2) API and tablet production are tied to named sites
Regulatory labeling for XOSPATA connects supply to named manufacturing sites for both the drug substance and the finished drug product (Source: XOSPATA U.S. Prescribing Information.).
Actionable supplier-screening checklist for XOSPATA projects
Use the label’s named manufacturing sites to anchor diligence for:
- Quality system compatibility: facility’s compliance history for sterile vs oral solid (oral solid controls still require GMP, process validation, and change control).
- API-to-drug product linkage: confirm whether the API manufacturer is the same as (or segregated from) tablet release sites.
- Inventory risk: identify whether the label lists multiple sites (platform redundancy) or a single site per stage.
(Anchor: XOSPATA labeling supplier/manufacturer sections.)
Key Takeaways
- XOSPATA’s U.S. commercial sponsor is Astellas Pharma US, Inc. (Source: XOSPATA U.S. Prescribing Information.)
- Finished drug product and drug substance supply are governed by named manufacturing sites disclosed in XOSPATA’s U.S. prescribing information (Source: XOSPATA U.S. Prescribing Information.)
- For supplier diligence, start with the label’s “manufactured for/manufactured by” and drug product/drug substance references, then map those sites to GMP status and capacity.
FAQs
-
Is XOSPATA supplied as a branded tablet with finished dose manufacturing controls?
Yes. XOSPATA is marketed as gilteritinib tablets with manufacturing and batch release disclosed in U.S. labeling. (Source: XOSPATA U.S. Prescribing Information.)
-
Who is the U.S. NDA holder for XOSPATA?
Astellas Pharma US, Inc. (Source: XOSPATA U.S. Prescribing Information.)
-
Where can I confirm the finished drug product manufacturer?
In the “Manufactured for/Manufactured by” and related sections of the XOSPATA U.S. Prescribing Information. (Source: XOSPATA U.S. Prescribing Information.)
-
Where can I confirm the gilteritinib API manufacturing sites?
In the regulatory/label materials that identify drug substance manufacturing references. (Source: XOSPATA U.S. Prescribing Information.)
-
Are API and tablet manufacturing performed under the same company network?
The labeling links API and drug product supply within the same authorization and distribution framework under the NDA holder’s responsibility. (Source: XOSPATA U.S. Prescribing Information.)
References (APA)
- Astellas Pharma US, Inc. (n.d.). XOSPATA (gilteritinib) prescribing information. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/
