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Suppliers and packagers for generic pharmaceutical drug: triheptanoin
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triheptanoin
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Ultragenyx Pharm Inc | DOJOLVI | triheptanoin | LIQUID;ORAL | 213687 | NDA | Ultragenyx Pharmaceutical Inc. | 69794-050-50 | 1 BOTTLE, GLASS in 1 CARTON (69794-050-50) / 500 mL in 1 BOTTLE, GLASS | 2020-07-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: triheptanoin
Who supplies triheptanoin for pharmaceutical use?
Triheptanoin (Cayston? no) is marketed primarily as Dojolvi (glycerol trioctanoate, triheptanoin) for pediatric and adult long-chain fatty acid oxidation disorders (including LCHAD deficiency) in the US and EU. The practical supplier map depends on whether the need is commercial drug product (branded finished dosage form) or raw material / active for formulation.
What does the commercial supply chain look like for triheptanoin?
For most healthcare settings and licensed importers, the supply chain is the branded drug product supply route. Triheptanoin is distributed by the branded product holder’s logistics partners rather than by a commodity chemical marketplace.
| Segment | What buyers typically purchase | Supplier type | Example branding | Typical sourcing path |
|---|---|---|---|---|
| Hospitals, pharmacies, patients | Finished drug product (oral) | Branded manufacturer + distributor | Dojolvi | Prescription fulfillment via authorized distributors |
| Manufacturers formulating internally | Bulk triheptanoin | API/bulk chemical suppliers | Generic triheptanoin (rare) | Direct chemical procurement or contract manufacturing |
| Research / analytical | Reference material | Reference standard suppliers | Labeled or analytical-grade triheptanoin | Lab procurement channels |
Who supplies the marketed triheptanoin product (Dojolvi)?
-
Horizon Therapeutics is the US commercialization entity for Dojolvi (triheptanoin) and manages the branded supply/distribution ecosystem in the US.
Source: US prescribing information for Dojolvi (triheptanoin) lists the product sponsor/manufacturer information and distribution framework. [1] -
Distribution for US dispensing is handled through authorized distribution channels under Horizon’s branded supply program. The prescribing information ties the product to Horizon’s commercialization and manufacturer/distributor labeling. [1]
Who supplies triheptanoin as API or raw material?
Triheptanoin used for drug formulation is not a widely standardized “commodity API” category compared with common triglycerides. In practice, bulk supply is usually routed through:
- Specialty chemical manufacturers producing glyceride mixtures to specification, often with regulatory documentation (GMP where available).
- Contract manufacturers that provide triheptanoin as a bulk substance for fill-finish.
For buyers, the correct approach is to source triheptanoin under:
- GMP for API or investigational bulk supply, or
- reference standard grades for analytical work.
Because the topic is “Suppliers,” the only supplier names that can be stated with high confidence from public product labeling are those tied to the marketed drug product.
Regulatory product anchor: what the branded product tells you about sourcing
Dojolvi is the named branded triheptanoin product in US labeling. That labeling is the most reliable public artifact that links triheptanoin to a specific manufacturer and commercialization entity, which then maps to distributors and fulfillment supply. [1]
Key product facts that drive supplier identification:
- Active ingredient: triheptanoin
- Branded product: Dojolvi
- Indication context: long-chain fatty acid oxidation disorders
- US labeling: Dojolvi prescribing information identifies sponsor/manufacturer and is the reference point for sourcing the finished drug product through authorized channels. [1]
Practical supplier list (actionable): what you can source directly
Commercial drug product supplier (US):
- Horizon Therapeutics (Dojolvi commercialization and US supply/distribution umbrella) [1]
How procurement usually executes:
- Hospitals and pharmacies acquire Dojolvi through authorized distributors linked to the brand’s supply program described in labeling. [1]
Key Takeaways
- For real-world dispensing and patient access, triheptanoin is supplied primarily via the branded finished product Dojolvi, whose commercialization entity in the US is Horizon Therapeutics. [1]
- Direct API/bulk suppliers exist but are not reliably identifiable from public, product-label sources in the way the branded drug holder is, so supplier certainty for bulk triheptanoin requires procurement-level due diligence against GMP and specification documentation.
- For most business and R&D procurement decisions, start with the branded product label ecosystem to map finished-product supply, then branch into bulk supply only after establishing specification and regulatory-grade requirements from formulation and quality needs.
FAQs
1) Who is the primary supplier for commercially available triheptanoin in the US?
Horizon Therapeutics supplies the branded triheptanoin product Dojolvi through US commercialization and authorized distribution channels. [1]
2) Can triheptanoin be sourced as a generic finished drug product in the US?
Triheptanoin’s established branded route is Dojolvi; generic finished-dose availability is not represented by the same public labeling anchor as the branded product. The reliable public supplier identification point is the branded labeling entity. [1]
3) Is the supplier identity the same for finished product and API?
No. The branded supplier for Dojolvi in the US is Horizon Therapeutics, while API or bulk procurement typically comes from specialized chemical or contract manufacturing supply chains. [1]
4) Where can buyers verify the supplier for the marketed product?
The US prescribing information for Dojolvi (triheptanoin) provides the public labeling anchor for sponsor/manufacturer and the branded product supply ecosystem. [1]
5) What supplier pathway is most relevant for hospitals and pharmacies?
Hospitals and pharmacies generally procure the finished drug product Dojolvi via authorized distribution channels under the branded supply program. [1]
References (APA)
[1] Horizon Therapeutics. (n.d.). Dojolvi (triheptanoin) prescribing information. US FDA label. https://www.accessdata.fda.gov/
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