Last updated: April 26, 2026
Who Supplies Dasatinib to the Pharmaceutical Supply Chain?
What is the dasatinib supply chain structure?
Dasatinib is a small-molecule tyrosine kinase inhibitor used in oncology. Production typically splits into two upstream supplier categories:
- API (active pharmaceutical ingredient) suppliers: manufacture dasatinib or contract manufacture it under GMP.
- Excipients, intermediates, and contract manufacturing suppliers: provide key starting materials, reagents, and finished-dose manufacturing services (tablet/capsule), often alongside sterile/packaging vendors depending on dosage form.
API suppliers for dasatinib
Dasatinib is widely manufactured and sold through generic and branded supply channels. The most reliable, actionable supplier identification is via:
- FDA Orange Book (ANDA/NDA labels) listing the approved manufacturers of dasatinib-containing products, and
- GMP manufacturer registries and corporate supplier lists tied to those approved products.
Which companies sell approved dasatinib products in the US (Orange Book)?
The FDA Orange Book lists manufacturers (applicants/holders and labeler equivalents) for approved dasatinib products. For supplier mapping, the Orange Book entries are the most directly linked to regulatory authorization.
| US approved dasatinib (examples by labeler/applicant in the Orange Book) |
Labeler / Applicant (typical supplier identity) |
Coverage |
| Bristol-Myers Squibb Company (Sprycel) |
Originator brand holder for dasatinib tablets in the US |
| Multiple generic applicants under ANDA |
Generic product suppliers marketed under their labeler/applier IDs |
This section cannot be fully completed to a specific supplier list without the Orange Book product-level table for dasatinib. Without that dataset in the prompt, listing named API suppliers would risk inaccuracy (e.g., confusing labeler, packager, and API source, or listing companies that do not currently supply the US-labeled dosage).
What role do contract manufacturers (CDMOs) play?
For dasatinib, many market participants use CDMOs for:
- API synthesis and purification (stepwise or full API production)
- Finished-dose formulation and scale-up
- Blow-fill-then-pack or standard tablet/capsule packaging lines
- Analytical method transfer and batch release testing
CDMO usage is common in generics, where multiple firms compete while relying on one or more specialized synthesis routes and QC systems. These suppliers are often not visible without batch-level sourcing disclosure or corporate supply-chain disclosures.
Intermediates and critical materials suppliers
Dasatinib API manufacturing uses specialized heterocycles and tailored synthetic intermediates. In practice, firms source intermediates from:
- Custom chemical manufacturers (intermediate synthesis under confidential specs)
- Specialty reagent suppliers for key steps
- Starting-material manufacturers with route-specific controls
However, supplier names for the specific dasatinib intermediates are typically confidential and are not consistently disclosed in public sources.
Best-practice approach for identifying “who supplies dasatinib”
A defensible supplier map requires linking:
- Regulatory labeler/applicant (Orange Book)
- Dosage form strength(s) (tablets and/or capsule forms depending on the product)
- GMP API source disclosure where available (DMF references, if linked)
- Country-level manufacturing sites (often required under GMP inspections, but not uniformly public)
This is how buyers verify whether an “API supplier” is the same entity as the US labeler or merely a downstream packager.
Key Takeaways
- Dasatinib supply is typically segmented into API manufacturers (or API CDMOs) and finished-dose manufacturers/packagers.
- The most actionable public starting point for “who supplies” is FDA Orange Book labeler/applicant listings for dasatinib products.
- Direct intermediate and API raw-material supplier names are often not publicly disclosed; supplier identification for these levels usually needs Orange Book/DMF mapping or batch sourcing documentation.
- A complete, accurate supplier list cannot be produced from the prompt content alone without the specific Orange Book product table for dasatinib.
FAQs
1) Are dasatinib API suppliers the same as the companies listed on the US label?
Not necessarily. Orange Book labeler/applicant identities can include holders and packagers. The actual API manufacturing site can differ and is often tied to DMF references.
2) What public source most directly identifies dasatinib suppliers in the US?
The FDA Orange Book for dasatinib-containing products is the primary source for approved product labeler/applicant identification.
3) Why don’t intermediate suppliers appear consistently in public databases?
Intermediate manufacturing is commonly conducted by specialty chemical firms under confidential agreements and specific route controls, and intermediates often are not disclosed at supplier level in regulatory filings.
4) How do buyers verify an API supplier for dasatinib?
By mapping Orange Book entries to the DMF-linked API manufacturing information and confirming GMP status at the manufacturing sites, plus incoming material documentation and CoA release history.
5) Is dasatinib supply centralized or distributed among multiple manufacturers?
It is distributed. Brand and multiple generic product manufacturers coexist, with API and formulation manufacturing spread across different GMP facilities.
References
[1] U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
