Last updated: May 24, 2026
DAURISMO is glasdegib, an oral small-molecule inhibitor of Hedgehog pathway signaling. Public, sourceable details on the full upstream supply chain (API makers, CDMOs by dosage form strength, and finished-goods packagers) are not sufficient in the provided context to identify specific supplier names with a complete audit trail.
What suppliers manufacture DAURISMO (glasdegib) API and finished tablets?
No complete, citable list of named suppliers for DAURISMO’s API and finished dosage form can be produced from the information available in this prompt.
API sourcing: who makes the glasdegib active ingredient?
A supplier-by-supplier answer requires verifiable disclosures in documents such as FDA drug master files, Orange Book manufacturing/labeler data tied to application holders, European Medicines Agency manufacturing-authorisation listings, or publicly indexed batch/CMC references. Those inputs are not present here.
Finished dosage form: who manufactures DAURISMO tablets?
The same limitation applies to finished-goods manufacturing. Without the Orange Book “Manufactured for” / “Repackaged by” / “Labeler” mapping to specific facilities and an auditable CMC disclosure trail, any named supplier list would be non-actionable.
What does the FDA Orange Book show about DAURISMO manufacturers and labelers?
No Orange Book data (application number, dosage form, NDC mappings, and listed manufacturing sites) is included in the provided context, so the supplier list cannot be derived.
Which NDCs correspond to DAURISMO strengths?
Not provided.
Does the Orange Book list multiple manufacturing sites for glasdegib?
Not provided.
Who supplies glasdegib under CDMO contracts and toll manufacturing?
No contract supplier list can be stated without CMC disclosures, facility identifiers, or Orange Book/DMF crosswalks for DAURISMO’s application.
What contract manufacturing footprints exist for oncology small molecules like glasdegib?
General CDMO patterns exist in the sector, but identifying the specific DAURISMO CDMO ecosystem requires the application-specific facility and chain-of-custody data that is not present here.
How do DAURISMO supplier changes affect risk for generic entry or litigation?
Without a manufacturer-by-manufacturer baseline and supply-chain history, the supplier-impact assessment cannot be completed.
Does a supplier switch trigger new IP or data requirements?
That analysis is application-specific and depends on whether changes affect regulatory filing content (e.g., process validation comparability) and whether the supplier change overlaps with any patent-protected manufacturing methods. No such details are provided.
Key Takeaways
- A complete, named supplier map for DAURISMO (glasdegib) cannot be produced from the provided information.
- Identifying the specific API and finished-goods manufacturers requires Orange Book labeler/manufacturing site data, DMF or CMC disclosures, and facility-specific listings, none of which are present in this prompt.
FAQs
- Is DAURISMO (glasdegib) sourced from a single API supplier or multiple?
- Which companies manufacture DAURISMO tablets for the US market?
- How can I find the manufacturing sites listed for DAURISMO in the Orange Book?
- Does DAURISMO use a DMF that names the glasdegib API manufacturer?
- Do supplier changes for glasdegib affect FDA approval supplements or labeling?
References
No sources were provided or retrievable within the constraints of the prompt.
