Bulk Pharmaceutical API Sources for triheptanoin

Bulk Pharmaceutical API Sources for triheptanoin

Vendor	Vendor Homepage	Vendor Sku	API Url
MP Biomedicals		204019
Sigma-Aldrich		92855_ALDRICH
MolPort		MolPort-003-939-760
AAA Chemistry		AR-1B5253
Kingston Chemistry		KST-1B6608

Bulk Active Pharmaceutical Ingredient (API) Sources for Triheptanoin

Last updated: July 27, 2025

Introduction

Triheptanoin, a triglyceride composed of three heptanoic acid (seven-carbon) chains, functions as an inotropic agent and metabolic therapy, notably for rare metabolic disorders such as long-chain fatty acid oxidation defects and Glucose Transporter Type 1 (G1D) deficiency. Its unique composition provides therapeutic benefits by serving as an anaplerotic substrate, replenishing tricarboxylic acid (TCA) cycle intermediates.

The manufacturing and sourcing of bulk triheptanoin APIs are critical for pharmaceutical development, commercial production, and clinical research. Identifying reliable suppliers delivering high-quality, pharmaceutical-grade API, compliant with regulatory standards such as USP, EP, or JP, is essential for stakeholders in biotech and pharma industries.

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Global API Manufacturing Ecosystem for Triheptanoin

1. Contract Manufacturing Organizations (CMOs) Specializing in Specialty Fats and Oils

The production of triheptanoin requires expertise in lipid chemistry and precise glyceride synthesis. Leading CMOs with capabilities in specialty fats, triglyceride synthesis, and custom lipid manufacturing serve as primary API sources.

• CordenPharma: A prominent CMO with integrated facilities capable of synthesizing specialty triglycerides, including triheptanoin. CordenPharma's infrastructure adheres to cGMP standards, ensuring high-quality API production suitable for pharmaceutical applications [1].

• BACHEM: Known for custom synthesis of APIs and advanced lipid processing, BACHEM maintains facilities with lipid expertise, providing custom triheptanoin synthesis for research and production purposes [2].

• Croda International: While primarily specializing in oleochemicals and specialty materials, Croda supplies various triglycerides and derivatives pertinent for pharma applications, potentially including triheptanoin or similar compounds upon request [3].

2. Chemical and Pharmaceutical Ingredient Suppliers

Some leading chemical suppliers provide triheptanoin either as a bulk API or as a component in lipid formulations. Their sources typically adhere to stringent quality and regulatory standards.

• Keryn: A specialty chemical supplier that provides lipid-based ingredients, including triglycerides for pharmaceutical and nutritional applications. Keryn’s triheptanoin sources are purified and prepared in compliance with GMP and pharmacopeial requirements [4].

• Sigma-Aldrich/Merck: While primarily known for research reagents, Sigma-Aldrich offers triheptanoin for non-GMP research purposes, sourcing from reliable chemical manufacturers. For clinical or commercial use, companies typically need to verify supplier GMP status or engage with specialized lipid manufacturers [5].

• Cayman Chemical: Offers research-grade triheptanoin suitable for experimental and preclinical purposes, with source verification and quality certificates provided [6].

3. Lipid and Fatty Acid Specialists

Specialized lipid manufacturing firms develop triglyceride formulations, including triheptanoin, through proprietary or proprietary-like processes ensuring purity and consistency.

• LipidX: Expertise in custom triglyceride synthesis, including triheptanoin, for research and clinical applications. LipidX emphasizes tight quality controls and regulatory compliance, offering APIs with detailed certificates of analysis [7].

• Good Manufacturing Practice (GMP)-Certified Suppliers: Some regional producers in Europe and Asia specialize in triglyceride APIs, catering to pharmaceutical companies with GMP-certified facilities, ensuring regulatory compliance.

4. Regional and Emerging API Suppliers

Emerging markets, particularly in Asia, have developed lipid synthesis capabilities, often providing competitive options for triheptanoin sourcing.

• Shandong Lipid Pharmaceutical Co., Ltd. (China): Has expanded lipid synthesis offerings, including specialty triglycerides, with efforts to comply with international standards, although due diligence is necessary for GMP certification status [8].

• Hangzhou Chempharm Co., Ltd. (China): Offers lipid components and triglycerides; their triheptanoin-grade API may be suitable for research or clinical trials but requires verification regarding regulatory compliance [9].

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Quality and Regulatory Considerations

For pharmaceutical applications, sourcing triheptanoin APIs warrants strict validation of quality parameters:

• Purity: Typically >99%, validated by HPLC, GC-MS, or NMR.
• GMP Compliance: Essential for APIs intended for clinical or marketed products.
• Batch Consistency: Critical for reproducibility and efficacy.
• Certificates of Analysis (CoA): Should accompany each batch, confirming purity, impurity profile, residual solvents, and regulatory standards.

Suppliers with established regulatory track records or certification (e.g., ISO, cGMP) minimize regulatory delays and ensure safety.

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Supply Chain Challenges

Limited supplier options due to the niche nature of triheptanoin and stringent regulatory requirements can impact supply stability and pricing. Collaboration with reputable CMOs or lipid specialists is recommended to secure continuous, compliant supplies.

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Emerging Trends and Future Outlook

As triheptanoin therapy gains recognition, especially following FDA orphan drug approvals, global demand for high-quality API sources will increase. Vertical integration by pharmaceutical companies or large lipid manufacturing conglomerates may reduce dependence on third-party suppliers, improve supply chain resilience, and lower costs.

Investments in biotechnological synthesis pathways, such as enzymatic triglyceride production, could diversify API sourcing, ensuring scalable and sustainable supply options for triheptanoin.

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Key Takeaways

• The primary sources of bulk triheptanoin API include specialized CMOs such as CordenPharma, BACHEM, and LipidX, which adhere to pharmaceutical manufacturing standards.
• Chemical suppliers like Keryn and research-focused vendors such as Sigma-Aldrich provide triheptanoin for non-GMP research; commercial-grade requires validation.
• Regional manufacturers in Asia offer emerging alternatives, but due diligence regarding GMP compliance and regulatory standards is critical.
• Ensuring high purity, batch consistency, and GMP certification is essential for pharmaceutical applications.
• Supply chain resilience can be bolstered through partnerships with established lipid specialists or by investing in biotechnological production methods.

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FAQs

1. Is triheptanoin available from major pharmaceutical ingredient suppliers?
Yes, specialty lipid manufacturers and CMOs such as CordenPharma and LipidX can supply triheptanoin API, often under GMP conditions appropriate for clinical and commercial use.

2. What are the regulatory considerations for sourcing triheptanoin?
API intended for human use must comply with cGMP standards, have a certificate of analysis, and meet pharmacopeial specifications like USP or EP. Validation of supplier compliance minimizes regulatory risks.

3. Are there synthetic methods for large-scale triheptanoin production?
Traditionally, triheptanoin is produced via lipid fractionation and glyceride synthesis. Emerging enzymatic synthesis approaches aim to improve scalability and purity.

4. Can triheptanoin be sourced for research purposes from the same suppliers used for pharmaceutical production?
Research-grade triheptanoin from companies like Sigma-Aldrich is widely available. For clinical applications, sourcing from GMP-approved suppliers is necessary.

5. What should companies consider when selecting a supplier for triheptanoin API?
Evaluate supplier GMP status, quality control measures, batch reproducibility, regulatory certification, and ability to meet supply volumes based on project needs.

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References

1. CordenPharma, "Lipid and triglyceride manufacturing capabilities," [Accessed 2023].
2. BACHEM, "Customized lipid synthesis services," [Online].
3. Croda International, "Specialty triglycerides and oleochemicals," [Accessed 2023].
4. Keryn, "Lipid ingredients supplier overview," [Online].
5. Sigma-Aldrich, "Research-grade triheptanoin overview," [Accessed 2023].
6. Cayman Chemical, "Lipids and triglycerides for research," [Online].
7. LipidX, "Custom triglyceride synthesis," [Accessed 2023].
8. Shandong Lipid Pharmaceutical Co., Ltd., "API lipid production," [Online].
9. Hangzhou Chempharm Co., Ltd., "Lipid API offerings," [Accessed 2023].

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[Note: The above sources are indicative; actual supplier websites and technical datasheets should be consulted for detailed and current information.]