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Suppliers and packagers for TURALIO
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TURALIO
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Daiichi Sankyo Inc | TURALIO | pexidartinib hydrochloride | CAPSULE;ORAL | 211810 | NDA | Daiichi Sankyo Inc. | 65597-407-20 | 1 BOTTLE in 1 CARTON (65597-407-20) / 120 CAPSULE in 1 BOTTLE | 2023-02-01 |
| Daiichi Sankyo Inc | TURALIO | pexidartinib hydrochloride | CAPSULE;ORAL | 211810 | NDA | Daiichi Sankyo Inc. | 65597-407-28 | 1 BOTTLE in 1 CARTON (65597-407-28) / 28 CAPSULE in 1 BOTTLE | 2023-02-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for TURALIO
Who Supplies Turalio (Pexidartinib)?
Turalio is the brand name for pexidartinib, an oral small-molecule used in tenosynovial giant cell tumor (TGCT). This page lists the key supplier roles tied to the product supply chain: marketing authorization holder, branded manufacturer/labeler, and the typical contract manufacturing and distribution pattern used for specialty oncology oral drugs.
What company supplies Turalio under the brand?
Turalio (pexidartinib) is marketed in the U.S. by Daiichi Sankyo, Inc. (U.S. label). The company listed as applicant/holder on the product label is Daiichi Sankyo, Inc. for Turalio.
The product is supplied in the U.S. as an oral drug product by the label holder’s downstream distribution network and contracted manufacturing sites (see “Drug product manufacturing and labeling” below) (U.S. Prescribing Information, Turalio).
Who manufactures the drug product and supplies the finished tablets?
The U.S. prescribing information identifies the manufacturer of the drug product (tablet) and the manufacturer/packager for labeling and distribution through the standard label “Manufactured for” / “Distributed by” and site disclosure structure (U.S. Prescribing Information, Turalio).
For Turalio, the prescribing information lists the following supplier roles on the packaging/labeling line items (U.S. Prescribing Information, Turalio):
| Supplier role (on-label) | Company / entity | Where it appears |
|---|---|---|
| Label holder / applicant / marketing authorization holder (U.S.) | Daiichi Sankyo, Inc. | U.S. Prescribing Information (Turalio) |
| Drug product manufacturing (finished dose) | Disclosed on-label as “Manufactured by / for” | U.S. Prescribing Information (Turalio) |
| Distribution / supply chain | Disclosed as “Distributed by” | U.S. Prescribing Information (Turalio) |
Key point for procurement diligence: Turalio’s supplier set is not limited to a single “raw material supplier.” It usually includes (1) active pharmaceutical ingredient (API) supply, (2) drug product contract manufacturing and packaging, and (3) commercial distribution under the label holder.
Who supplies the API (pexidartinib) and intermediates?
API and intermediate sourcing for pexidartinib is not consistently listed by name in the public prescribing label. Public label documents typically do not enumerate API suppliers. Procurement and competitive benchmarking generally relies on one or more of these evidence streams: regulatory filings (CMC sections), DMF-linked disclosure, and patent-family prosecution records.
For Turalio, public label materials primarily disclose who manufactures the finished dosage form rather than the API supplier identity (U.S. Prescribing Information, Turalio).
How does the Turalio supply chain typically break down for contracting?
Even without public API-supplier naming, you can map Turalio procurement to contract categories that drive supplier qualification:
-
API manufacturing (pexidartinib)
- Often handled via API-specific contract manufacturing with DMF-linked controls.
- Requires full impurity control and polymorph/solid-state control, plus ongoing process performance verification.
-
Drug product manufacturing (tablets/capsules as applicable)
- Tablet manufacturing includes granulation, blending, compression, coating (if present), and tablet inspection.
- Requires compliance to cGMP and validated cleaning for cross-contamination control.
-
Packaging, labeling, and release testing
- Labeling vendors coordinate with label holder.
- Release testing labs may be internal or contracted (stability, potency/assay, dissolution, and impurity profiling).
-
Commercial distribution
- Usually owned or managed by the label holder’s distribution partners in-country.
Where to verify supplier identity (the fastest route for diligence)?
Use Turalio’s U.S. label as the primary source for the drug product manufacturer and distribution contacts that appear on the packaging and prescribing documents (U.S. Prescribing Information, Turalio). For API supplier identification, use regulatory dossier linkages (DMF references where available) and patent prosecution disclosures.
Turalio: Supplier Facts Table (Publicly Label-Discernible)
| Item | Supplier identity disclosed publicly? | Source type |
|---|---|---|
| U.S. label holder / marketing authorization holder | Yes | U.S. Prescribing Information (Turalio) |
| Finished dose manufacturer | Yes | U.S. Prescribing Information (Turalio) |
| API supplier (pexidartinib) | Not reliably by name in label | Requires CMC/DMF/patent record review |
| Intermediates supplier | Not reliably by name in label | Requires CMC/DMF/patent record review |
| Commercial distribution partner(s) | Not always named individually | Often “Distributed by” on label |
Key Takeaways
- Daiichi Sankyo, Inc. is the U.S. label holder/marketing entity for Turalio (pexidartinib) (U.S. Prescribing Information, Turalio).
- Public prescribing materials typically identify the finished drug product manufacturer and distribution roles, while API supplier identity is usually not named in the label document.
- Supplier qualification for Turalio should be structured by contracting category: API, drug product manufacturing, packaging/labeling, and distribution.
FAQs
1) Who is the label holder for Turalio in the U.S.?
Daiichi Sankyo, Inc. (U.S. Prescribing Information, Turalio).
2) Does the Turalio label name the tablet manufacturer?
Yes. The U.S. prescribing information identifies the finished drug product manufacturer via the standard “Manufactured by / for” and distribution lines (U.S. Prescribing Information, Turalio).
3) Are pexidartinib API suppliers named in the Turalio label?
Not consistently. The label typically focuses on the finished dosage form and label holder, not the named API supplier (U.S. Prescribing Information, Turalio).
4) What supplier categories matter most for Turalio procurement?
API supply (pexidartinib), drug product manufacturing, packaging and labeling, and commercial distribution (U.S. Prescribing Information, Turalio).
5) What document is the fastest public confirmation for finished-dose supplier identity?
The U.S. Turalio prescribing information (label) (U.S. Prescribing Information, Turalio).
References (APA)
[1] U.S. Prescribing Information. Turalio (pexidartinib). Daiichi Sankyo, Inc.
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