Last updated: May 27, 2026
Quizartinib Dihydrochloride Suppliers: Who Manufactures API and Final Drug Products for the AML Therapy?
Quizartinib dihydrochloride is supplied through a limited, tightly controlled commercial chain tied to Daiichi Sankyo’s quizartinib program for relapsed or refractory FLT3-mutated acute myeloid leukemia (AML). Public disclosure on named contract manufacturing organizations (CMOs) for quizartinib dihydrochloride API and finished dosage forms is sparse, and most supplier-identifying details are not consistently published in regulatory databases or label disclosures in a way that supports a complete, reliable “who supplies whom” map for every stage (API, drug product, packaging).
Given the absence of consistently citable supplier identifiers for quizartinib dihydrochloride at both API and finished-dosage stages in publicly available sources, a complete and accurate supplier list cannot be produced under a strict data-verification standard.
What companies supply quizartinib dihydrochloride API?
Answer: No supplier list can be produced from verifiable public sources that cleanly identifies API manufacturing sites or named API suppliers for quizartinib dihydrochloride.
Which databases usually list quizartinib API manufacturers?
- FDA drug establishment and listing records
- Drug Master Files (DMFs) and cross-references
- European Medicines Agency (EMA) product documentation and manufacturing declarations
- Clinical trial material procurement records
Public-facing access to the exact API supplier names or DMF holders for quizartinib dihydrochloride is not consistently discoverable in a way that supports a definitive supplier roster.
Which CDMOs make quizartinib dihydrochloride tablets or capsules?
Answer: A verified list of CDMOs making quizartinib dihydrochloride finished dosage forms cannot be compiled from citable public sources.
What finished dosage forms exist for quizartinib?
- Public product information indicates an oral solid formulation is used in clinical and regulatory contexts.
- However, supplier-level manufacturing attribution (site and company) for the finished drug product is not consistently published in a manner that supports a supplier enumeration.
How does the supply chain for quizartinib compare with other FLT3 inhibitors?
Answer: Supply-chain transparency for FLT3 inhibitors varies widely; for quizartinib specifically, publicly verifiable supplier-name mappings are limited.
Typical cross-drug pattern
- API production often sits with a small number of specialty chemical manufacturers with DMF involvement.
- Finished-dose manufacturing is frequently handled by global sterile and non-sterile CDMOs under NDA-level constraints.
For quizartinib, the public record does not yield a complete, supplier-identifiable map comparable to drugs where manufacturing participants are explicitly disclosed.
What is the Orange Book status of quizartinib and does it name suppliers?
Answer: Orange Book listing is not a reliable way to identify API or CMO suppliers for quizartinib; supplier identities are generally not listed as structured “who manufactures the API” fields.
Why Orange Book typically does not resolve suppliers
- The Orange Book focuses on active ingredient status, patents, and exclusivity.
- Manufacturing information is generally not presented as a supplier roster.
What generic entry risks exist for quizartinib dihydrochloride suppliers?
Answer: Without a supplier roster, the generic entry impact on supplier relationships cannot be mapped.
What matters for supplier risk in practice
- patent and exclusivity status
- regulatory pathway selection (ANDA vs. 505(b)(2))
- ability to qualify the manufacturing process for the API polymorph and salt form (dihydrochloride)
- analytical method transfer feasibility for assay and impurities
What patent estate controls manufacturing and salt form for quizartinib dihydrochloride?
Answer: A supplier-identifying manufacturing barrier assessment cannot be completed without citable patent mappings to specific process or formulation IP for the dihydrochloride salt and the commercial dosage form.
What supplier-relevant IP usually covers
- API synthesis routes
- polymorph and salt form claims (including dihydrochloride)
- impurity profiles and process control
- formulation and release characteristics
A precise, supplier-impacting IP chart for quizartinib dihydrochloride cannot be produced in a way that meets a strict accuracy standard here.
What filings show quizartinib manufacturing sites and who are the license holders?
Answer: A verified list of manufacturing sites and the companies operating them cannot be compiled from citable public sources within the constraints of this request.
What documents often contain site names
- FDA CMC sections in NDA/BLA medical reviews (not always public)
- EMA assessment reports (sometimes public but not consistently supplier-specific)
- U.S. FDA establishment inspection data (company name might not be linked to the drug product without mapping)
Key Takeaways
- A complete, accurate, verifiable list of API and finished-dose suppliers for quizartinib dihydrochloride cannot be produced from publicly citable sources under strict validation standards.
- Orange Book status does not provide a reliable supplier roster.
- Supplier risk analysis (generic entry, process IP, salt-form control) cannot be tied to named manufacturers without citable supplier identifications for quizartinib dihydrochloride.
FAQs
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Are quizartinib dihydrochloride suppliers listed in the FDA Orange Book?
Orange Book does not reliably disclose API or CDMO supplier identities.
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How can I find the API manufacturer for quizartinib dihydrochloride?
In practice, it requires mapping regulatory CMC content or DMF references to manufacturing companies, which is not consistently publicly citable for quizartinib.
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Do quizartinib dihydrochloride polymorph and salt-form patents affect supplier qualification?
Yes, but a supplier-specific IP barrier assessment requires citable patent-to-manufacturing mapping.
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Which pathway would a generic company use for quizartinib dihydrochloride?
Likely an ANDA or 505(b)(2) depending on the reference listed drug and data exclusivity, but pathway selection does not identify suppliers.
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Can inspection databases identify quizartinib drug product manufacturing companies?
They can list establishments, but linking establishments to “quizartinib dihydrochloride product” and producing a supplier roster requires additional deterministic mapping not available here.
References
- FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. (Accessed 2026).
- FDA Drug Establishment Registration and Drug Listing. U.S. Food and Drug Administration. (Accessed 2026).
- EMA assessment and public assessment reports for relevant quizartinib-containing products. European Medicines Agency. (Accessed 2026).
