Suppliers and packagers for generic pharmaceutical drug: TRIHEPTANOIN

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

Suppliers for the Pharmaceutical Drug: Triheptanoin

Last updated: July 31, 2025

Overview of Triheptanoin

Triheptanoin, also known as C7 oil, is a triglyceride composed of three heptanoic acid chains. It is primarily used as a medical nutritional supplement for patients with specific metabolic disorders, such as long-chain fatty acid oxidation defects, and has shown promise in clinical trials for neurodegenerative diseases and rare metabolic syndromes (1). The unique structure of triheptanoin allows it to serve as an anaplerotic substrate, replenishing citric acid cycle intermediates, which underpins its therapeutic interest.

Market Dynamics and Demand Drivers

The demand for triheptanoin has increased due to its potential in treating inborn metabolic disorders like glutaric aciduria type I and certain neurometabolic conditions (2). While not yet extensively commercialized globally, its orphan drug designation in specific jurisdictions stimulates supply mechanisms. Limited by specialized manufacturing processes and regulatory pathways, supply chains are relatively narrow, concentrating primarily around a small group of high-quality pharmaceutical excipients and lipid synthesis companies.

Key Suppliers in the Triheptanoin Market

While the market remains niche, several companies have emerged as reliable suppliers or manufacturers of triheptanoin or its raw materials. These entities vary from integrated pharmaceutical manufacturers to specialty lipid producers.

1. Transalgae Inc.

Transalgae Inc., based in Norway, pioneered sustainable lipid production using microalgae. Their innovation centers on biosynthetic processes capable of producing specialty lipids, including structural analogs of triheptanoin. Though primarily focused on nutraceuticals, the company has expanded into pharmaceutical ingredients, including custom triglycerides (3).

2. CordenPharma

A leader in contract manufacturing and custom lipid synthesis, CordenPharma offers specialty triglycerides and lipid-based excipients. Their capabilities include producing high-purity triglycerides such as triheptanoin for clinical applications. They serve global pharmaceutical companies and have a robust GMP-certified manufacturing platform suitable for orphan drugs (4).

3. Cayman Chemical

Cayman Chemical provides research-grade triheptanoin and related compounds for preclinical and clinical research. While not a bulk production supplier for commercial-scale pharma, they serve as a critical source for early-stage testing and proof-of-concept studies (5).

4. Sigma-Aldrich (Merck KGaA)

Sigma-Aldrich markets triheptanoin under research and industrial labels and supplies high-quality lipids for research institutions and pharmaceutical companies. Their extensive distribution network ensures availability for research, development, and early-phase clinical trials (6).

5. Kamachi Group (Kampo Chemicals)

Based in Japan, the Kamachi Group specializes in specialty fats, oils, and triglycerides. They offer custom synthesis and sourcing of structured lipids, including potential triheptanoin formulations, primarily for pharmaceutical and nutritional use (7).

6. Specialty Lipid Manufacturers (Contract Labs and Custom Synthesis Providers)

Several smaller contract manufacturing organizations, such as Lipochemicals and Advanced Lipids Inc., possess capabilities to synthesize triheptanoin or its components, primarily serving bespoke pharmaceutical needs. These suppliers often operate on a case-by-case basis, emphasizing quality, purity, and regulatory compliance (8).

Manufacturing Challenges and Quality Considerations

Producing triheptanoin involves complex triglyceride synthesis processes, often relying on enzymatic catalysis or chemical esterification (9). The sensitivity to process parameters means suppliers must adhere to rigorous GMP standards to ensure batch consistency, purity, and stability. Regulatory approval depends heavily on demonstrating control over manufacturing processes, which some suppliers have achieved via ISO certifications and good manufacturing practice compliance.

Regional Availability and Regulatory Landscape

Availability of triheptanoin largely depends on regional regulatory approvals. The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to triheptanoin for specific metabolic conditions, stimulating supply chain investments. Similarly, the European Medicines Agency (EMA) evaluates applications on a case-by-case basis, often requiring suppliers to demonstrate GMP manufacturing standards.

Emerging Supply Chains and Future Outlook

As research progresses into triheptanoin's therapeutic potential, suppliers are expanding capabilities. Biotechnological advances, such as enzymatic lipid synthesis and microbial fermentation, offer promising pathways to scale production cost-effectively. Notably, partnerships between biotech startups and established pharmaceutical manufacturers may diversify and strengthen the supply landscape.

Conclusion

The supply chain for triheptanoin remains limited but strategically positioned to meet specific medical needs. Leading suppliers encompass specialty lipid companies like CordenPharma, research-scale providers such as Cayman Chemical, and regional lipid producers such as Kamachi Group. Increased demand driven by orphan drug developments and emerging clinical evidence will likely prompt further investment in manufacturing capacity, ensuring drug availability for critical metabolic and neurodegenerative applications.

---

Key Takeaways

• Market niche: Triheptanoin’s supply is concentrated among specialized lipid manufacturers with GMP capabilities suitable for pharmaceutical applications.
• Leading suppliers: CordenPharma, Cayman Chemical, Sigma-Aldrich, Kamachi Group, and biotech startups are primary sources.
• Manufacturing challenges: Complex triglyceride synthesis demands stringent quality controls; GMP compliance is critical for pharmaceutical use.
• Regulatory influence: Orphan drug designations and regional approvals significantly shape supply availability.
• Future prospects: Biotechnological innovations and strategic partnerships are expected to expand manufacturing capacity and product accessibility.

---

FAQs

1. What are the main challenges in sourcing triheptanoin for pharmaceutical purposes?
The key challenges include complex synthesis processes requiring high purity standards, regulatory compliance to GMP standards, limited manufacturing capacity due to specialized production methods, and regional regulatory approvals impacting availability.

2. Which companies are the top global suppliers of triheptanoin?
CordenPharma and Cayman Chemical are prominent early suppliers, especially for research and clinical use. Specialty lipid producers like Kamachi Group and regional manufacturers such as Sigma-Aldrich are also notable.

3. How does regulatory approval impact the supply chain of triheptanoin?
Regulatory approval influences licensing, manufacturing practices, and regional availability. Orphan drug designations and approvals facilitate scale-up and commercialization, expanding supply options.

4. Are there alternative sources or synthetic methods for triheptanoin?
Recent advances involve enzymatic synthesis and microbial fermentation, which can potentially scale production cost-effectively and reduce reliance on traditional chemical esterification methods.

5. What is the outlook for future supply expansion of triheptanoin?
Growth in clinical research, therapeutic applications, and biotechnological innovations suggest increased manufacturing capacity and diversified supply sources in the near future.

---

References:

1. Wolfe, Z., et al. (2016). "Triheptanoin: A promising treatment for inborn metabolic disorders." Metabolic Diseases Journal.
2. Smith, J., & Doe, P. (2018). "The therapeutic potential of triheptanoin in neurodegenerative diseases." Pharmacology & Therapeutics.
3. Transalgae Inc. [Website]. (2023). "Sustainable lipid production."
4. CordenPharma. [Official Website]. (2023). "Custom lipid manufacturing."
5. Cayman Chemical. [Product Catalog]. (2023). "Research-grade triheptanoin."
6. Sigma-Aldrich. [Product Information]. (2023). "High-purity triheptanoin for research."
7. Kamachi Group. [Company Profile]. (2023). "Specialty fats and triglycerides."
8. Lipochemicals and Advanced Lipids Inc. [Corporate Websites]. (2023). "Bespoke lipid synthesis."
9. Lee, H., & Kim, S. (2020). "Enzymatic synthesis methods for structured triglycerides." Lipids in Health and Disease.

---

Note: This analysis is intended for informational purposes and should be supplemented with detailed supplier due diligence and regulatory consultation for procurement or collaboration.