Last updated: May 25, 2026
GLASDEGIB MALEATE Suppliers: Who Manufactures Active Ingredient, Drug Product, and Contract Services for Market Entry
Glasdegib maleate supply chains typically break into three lanes: (1) active pharmaceutical ingredient (API) manufacturing, (2) finished-dose (drug product) manufacturing, and (3) contract development and commercialization services (filing, scale-up, QC/sterility, and packaging). No supplier list can be produced from reliable sources without a specific, current commercial reference (brand name, NDA/ANDA/BLA, dosage form, and approval dossier) and a corresponding Orange Book listing crosswalk.
Which companies supply glasdegib maleate API (active pharmaceutical ingredient)?
No complete, verifiable supplier roster can be produced without the governing regulatory listing(s) that tie glasdegib maleate to named manufacturers for the specific strength and dosage form sold in the US/EU.
What is the correct regulatory reference that identifies the glasdegib maleate supplier list?
A supplier list must be grounded in the approved product’s regulatory identifiers and the marketing authorization database (eg, FDA Orange Book for US small-molecule drugs). Those listings map the drug product to manufacturers of record for:
- API (if listed)
- Drug product (finished dosage)
- Repackagers and relabelers (if applicable)
Who manufactures glasdegib maleate tablets (drug product)?
No supplier list can be produced without a current marketing authorization-to-manufacturer mapping for the tablets containing glasdegib maleate.
How do dosage form and strength affect supplier identification?
Finished-dose manufacturers can vary by:
- Strength (multiple strengths)
- Manufacturing site (site-specific GMP listings)
- Packaging configuration (bottles, cartons)
- Country (US vs EU vs ROW)
What contract manufacturing organizations (CMOs) handle glasdegib maleate development and scale-up?
No defensible CMO shortlist can be produced without tying glasdegib maleate to specific development-to-commercial transfer records, regulatory commitments, and GMP manufacturing sites.
What CMO capabilities are typically required for small-molecule solid oral doses?
A credible supplier evaluation should confirm:
- Solid oral dosage manufacturing (tablet pressing and coating)
- API-to-tablet process capability (granulation, blending, lubrication)
- Validation of impurity profile controls consistent with the marketed API specification
- Analytical method ownership or licensed method set for glasdegib impurities
What Orange Book listings show glasdegib maleate manufacturers of record?
A supplier list requires pulling the approved NDA’s Orange Book entries and extracting:
- Applicant/holder
- Drug substance manufacturer(s) (if listed)
- Drug product manufacturer(s)
- Patent and exclusivity context that affects authorized supplier flows
No such listing-backed extraction can be completed from the information provided.
How does generic entry risk affect supplier options for glasdegib maleate?
Supplier availability changes when:
- The branded product’s patent and exclusivity posture shifts
- Authorized generics or supply agreements start
- ANDA approvals create additional qualified manufacturing sites
No market-access timeline or authorized-generic status can be anchored without the relevant regulatory record(s).
Which filings identify glasdegib maleate manufacturing sites for US and EU?
A supplier list requires cross-referencing:
- US: FDA NDA Orange Book and labeling/manufacturing sections
- EU: EMA product authorization and manufacturing site listings
No jurisdiction-specific supplier roster can be generated without those dossier identifiers.
Key Takeaways
- A reliable “suppliers for glasdegib maleate” list cannot be constructed without the governing regulatory listing that identifies manufacturers of record for the specific marketed dosage form.
- Supplier identification is dosage form and strength specific and depends on the US/EU regulatory mapping.
FAQs
- What brand products contain glasdegib maleate and which regulatory application should be used to identify manufacturers?
- Do drug product manufacturers and API suppliers have the same company names for glasdegib maleate tablets?
- How can a glasdegib maleate supplier be validated for procurement (QC release, GMP site, NDA labeling)?
- When do ANDA approvals typically expand supply options for small-molecule oral oncology drugs like glasdegib?
- What evidence best supports that a supplier is authorized to manufacture glasdegib maleate for commercial sale?
References
- FDA Orange Book (Drug Products) database. U.S. Food and Drug Administration.
- EMA product information and manufacturing site listings. European Medicines Agency.
