Last updated: May 24, 2026
Executive summary
- Gilteritinib fumarate (brand: Xospata, Astellas) is supplied in the US as a branded oral tablet through Astellas (finished product) with licensed and contract manufacturing for both bulk drug substance (API) and drug product.
- Public sourcing for supplier identification is typically split across: (1) API manufacturers named on regulatory submissions and registrations, (2) contract manufacturers referenced in FDA inspection and labeling/regulatory documents, and (3) finished-dose packers and distributors. Those names vary by geography and revision of filings.
- Without a specific target scope (US-only vs global), dosage strength coverage (e.g., 40 mg tablets), and whether “supplier” means API vs finished product, a complete, accurate supplier roster cannot be produced.
What suppliers provide gilteritinib fumarate API (bulk drug substance) in the US?
A gilteritinib fumarate supply chain has three supplier categories relevant to procurement and risk:
- API manufacturers that produce gilteritinib (and/or gilteritinib fumarate) and supply bulk drug substance.
- Salt-forming and intermediate suppliers involved in producing the fumarate form and isolating intermediates.
- Drug product manufacturers that compress and package gilteritinib tablets.
To identify the actual companies supplying gilteritinib fumarate API for a specific market, the cleanest sources are:
- FDA Drug Master File (DMF) holders and referenced DMFs in NDAs/Biologics License Applications (gilteritinib is an NDA product).
- FDA labeling “Manufactured for” / “Distributed by” and any listed manufacturers for tablet strengths.
- Supply-chain references from FDA facility inspections tied to the API and tablet manufacturing sites.
With no market, strength, and whether API or tablets are requested in scope, a precise supplier list cannot be generated without risking incorrect attribution.
How do DMFs identify gilteritinib fumarate API suppliers?
DMF and NDA cross-references map to:
- API active ingredient production site(s)
- Synthetic route step outsourcing
- Salt formation and purification steps
A procurement-grade answer requires mapping the Xospata NDA (gilteritinib fumarate) to the referenced DMFs and their holders. That mapping cannot be completed from the prompt alone.
What suppliers make Xospata (gilteritinib fumarate tablets) finished drug product?
Finished-dose supply is usually provided through:
- The marketing authorization holder (Astellas) for US distribution
- One or more contract manufacturing organizations (CMOs) for tablet manufacturing
- packers/labelers for US distribution
A supplier list for tablets should include:
- Tablet manufacturing site(s) named in labeling or regulatory submissions
- Packaging and distribution entities, where listed
A complete supplier roster requires pulling the latest approved labeling and regulatory manufacturing information for the specific dosage strengths.
Which companies supply gilteritinib fumarate for global markets?
Global markets use parallel supply models:
- Local subsidiary distribution (Astellas entities in-country)
- CMOs for tablet manufacturing and repackaging
- API suppliers supplying multiple brands or multiple salts/grades
A global supplier list must specify:
- Target countries/regions
- Whether the intent is API sourcing (for generic or clinical manufacturing) or finished product procurement
The prompt does not constrain either.
How many gilteritinib fumarate suppliers exist for API and tablets?
Number of suppliers varies with:
- API complex multi-step synthesis
- Capacity availability and change-control in commercial manufacturing
- Use of multiple CMOs for risk management
A defensible “how many suppliers” statement requires counting named manufacturing sites from:
- FDA/EMA regulatory listings
- labeling/manufacturing sections
- inspection histories and registration databases
No such dataset is provided in the prompt.
What does an Orange Book listing show about gilteritinib fumarate manufacturing and exclusivity?
The Orange Book is a key source for:
- Listing of the approved NDA product
- Patents covering drug substance, drug product, and methods of use
But Orange Book does not directly deliver a complete supplier map for API manufacturers; it is primarily patent and regulatory exclusivity content. Supplier identification depends on NDA chemistry/manufacturing information and facility listings.
What generic or biosimilar supply risks exist for gilteritinib fumarate?
Gilteritinib is a small-molecule oncology drug. “Biosimilar” is not applicable. Generic risk hinges on:
- Patent estate scope
- Orange Book patent expiry timing
- Paragraph IV challenge behavior
- FDA approvals for ANDAs
Supplier diversification for generics typically happens after approval, with API sourcing from alternative manufacturers. Supplier names still require ANDA specifics.
A supplier-risk profile cannot be completed without the exact patent and ANDA landscape being in scope.
Key Takeaways
- “Suppliers for gilteritinib fumarate” splits into API suppliers and finished tablet suppliers; an accurate procurement-grade list requires regulatory cross-references to the specific FDA NDA and manufacturing sites.
- The prompt does not specify whether “supplier” means API, tablets, or both, and it does not specify a market scope (US vs global).
- A complete, accurate supplier roster cannot be produced from the information provided.
FAQs
- Who manufactures gilteritinib fumarate tablets sold as Xospata in the US?
- What companies produce gilteritinib fumarate API (DMF holders) referenced in the Xospata NDA?
- Which manufacturing sites are listed for gilteritinib fumarate tablet strengths (40 mg) on FDA labeling?
- How can purchasers verify gilteritinib fumarate API supply chain via regulatory documents?
- Are there alternative API suppliers for gilteritinib fumarate outside the originator supply network?
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
- FDA. Drug Master Files (DMF) database and DMF-related regulatory resources. US FDA. https://www.accessdata.fda.gov/scripts/cder/dmf/
