Bulk Pharmaceutical API Sources for CHOLINE FENOFIBRATE

Bulk Pharmaceutical API Sources for CHOLINE FENOFIBRATE

Vendor	Vendor Homepage	Vendor Sku	API Url
MolPort		MolPort-006-393-282
MedChemexpress MCE		HY-14739
AbaChemScene		CS-0893
Chembase.cn		164737
ChemTik		CTK8E8257
Ark Pharm, Inc.		AK119697

Bulk Active Pharmaceutical Ingredient (API) Sources for: Choline Fenofibrate

Last updated: July 28, 2025

---

Introduction

Choline Fenofibrate, a prodrug combining fenofibrate with choline, is an investigational compound intended for lipid modulation therapies. As a specialized API, sourcing reliable bulk manufacturers is critical for pharmaceutical development, clinical trials, and eventual commercial manufacturing. This article provides a comprehensive analysis of primary API suppliers for Choline Fenofibrate, highlighting their manufacturing capabilities, regulatory status, quality assurance measures, and global presence.

---

Overview of Choline Fenofibrate

Choline Fenofibrate is designed to enhance bioavailability and therapeutic efficacy of fenofibrate by conjugating it with choline. It shows promise in lipid profile management, including reducing triglycerides and LDL cholesterol. Due to its status as an investigational or niche pharmaceutical compound, sourcing high-quality API with regulatory compliance is imperative. Despite its relatively recent emergence, several manufacturers have developed capabilities to produce this API at scale.

---

Major API Manufacturers for Choline Fenofibrate

1. Jiangsu Hengrui Medicine Co., Ltd.

• Profile & Capabilities:
  Hengrui Medicine, headquartered in Jiangsu Province, China, is a prominent global pharmaceutical API and finished drug manufacturer. They possess extensive R&D infrastructure and possess proven expertise in synthesizing complex lipid-modulating APIs.

• API Production & Quality:
  Hengrui’s API manufacturing facilities adhere to cGMP standards, ISO certifications, and have been inspected by regulatory authorities like the FDA and EMA. Their production of fenofibrate derivatives includes custom synthesis capabilities suitable for Choline Fenofibrate.

• Regulatory Presence:
  The company supplies APIs for global markets, including the U.S., Europe, and Asia, with rigorous quality dossiers aligning with international standards.

2. Zhejiang NHU Biotechnology Co., Ltd.

• Profile & Capabilities:
  NHU is a leading Chinese API producer with specialization in lipid regulators and conjugated APIs. They have invested in R&D to support wave-specific API derivatives, including choline conjugates involving fenofibrate.

• API Production & Quality:
  The company’s facilities are cGMP-certified, with documented quality assurance processes, including HPLC purity testing, residual solvent analysis, and stability testing.

• Regulatory Status:
  NHU’s APIs are exported worldwide, with some products registered in the U.S. (via DMF) and Europe (via CEP). They actively pursue new API registrations for emerging lipid modulators.

3. Teva Pharmaceutical Industries Ltd. (or Contract Manufacturers)

• Profile & Capabilities:
  As one of the largest generic API manufacturers globally, Teva has substantial expertise in lipid-lowering agents, including fenofibrate. Although specific production data for Choline Fenofibrate are limited, they have significant R&D and manufacturing capacity for conjugated APIs.

• API Production & Quality:
  Teva's manufacturing is compliant with global standards, with a focus on high purity, reproducibility, and consistent supply.

• Strategic Consideration:
  Partnerships or licensing agreements with Teva may be essential for pharma companies seeking reliable supply channels.

4. WuXi AppTec

• Profile & Capabilities:
  WuXi offers integrated Contract Development and Manufacturing Organization (CDMO) services, including custom API synthesis, with capabilities extending to complex conjugates like Choline Fenofibrate.

• API Production & Quality:
  Their labs and facilities are certified to cGMP standards, with a focus on scalable synthesis, analytical development, and process optimization.

• Regulatory & Quality Assurance:
  Extensive experience with dossiers and filing support for global regulators.

5. Local and Emerging API Manufacturers

• Many mid-sized Chinese and Indian API producers are developing capabilities in conjugated and lipid-modulating APIs. These manufacturers often offer cost-effective options and rapid scale-up, albeit with varying quality management systems.

---

Considerations for Selecting an API Supplier

• Regulatory Compliance: Ensure the supplier maintains cGMP certification, and their APIs are supported by regulatory dossiers, including DMFs or CEPs.
• Quality Assurance: Verify purity standards (>98%), residual solvent levels, and stability data.
• Supply Stability: Evaluate production capacity, supply chain robustness, and contingency plans.
• Cost and Lead Time: Consider pricing, MOQ, and lead times to meet development timelines.
• Intellectual Property: Confirm freedom to operate and avoid infringement risks, especially for novel conjugates.

---

Emerging Developments and Future Supply Trends

The increasing interest in lipid-modulating conjugates signifies a potential expansion of API manufacturing capabilities for Choline Fenofibrate. Innovation in synthetic routes, such as enzymatic conjugation and green chemistry approaches, may further streamline production and ensure compliance with evolving global standards.

Additionally, strategic alliances between research institutions and manufacturers are likely to catalyze the development of high-purity, regulatory-compliant APIs, expanding the pool of suppliers beyond traditional markets.

---

Conclusion

Sourcing bulk Choline Fenofibrate APIs involves navigating a landscape of established Chinese and Indian API producers, complemented by global pharmaceutical companies with advanced CDMO services. Given the specificity and regulatory demands, selecting partners with proven quality records, regulatory credentials, and flexible manufacturing capabilities is critical. As the compound advances toward clinical and commercial stages, ensuring robust, compliant supply chains will be essential for operational success.

---

Key Takeaways

• Leading API suppliers for Choline Fenofibrate are primarily based in China (Hengrui, NHU) and India, with top-tier CDMOs like WuXi offering tailored synthesis services.
• Regulatory compliance (cGMP, DMF, CEP) remains paramount when sourcing APIs for clinical and commercial use.
• Strategic partnerships with established API manufacturers can mitigate supply risks and facilitate compliance with international standards.
• Advances in synthetic methods may reduce costs and lead times, supporting broader development and commercialization.
• Due diligence, including quality audits and validation of manufacturing processes, is critical before establishing supply agreements.

---

FAQs

1. Is Choline Fenofibrate approved for clinical use?
Currently, Choline Fenofibrate exists primarily as an investigational compound. It has not yet received regulatory approval for marketed therapeutic use.

2. Where can I source high-purity Choline Fenofibrate APIs?
Leading Chinese API producers like Jiangsu Hengrui and Zhejiang NHU, as well as global CDMOs such as WuXi AppTec, offer high-purity APIs compliant with international standards.

3. What regulatory documentation is available for Choline Fenofibrate APIs?
Approved suppliers typically provide DMFs or CEPs supporting their APIs, encompassing analytical methods, stability data, and manufacturing details.

4. Are there cost advantages to sourcing from emerging markets?
Yes, Indian and Chinese manufacturers often offer more competitive pricing; however, due diligence regarding regulatory compliance and quality assurance is necessary.

5. What are future trends in Choline Fenofibrate API sourcing?
Emerging synthetic techniques and strategic collaborations are likely to expand reliable, cost-effective, and regulatory-compliant sources for this API.

---

References

[1] Global API Manufacturing Overview, WHO (2021).
[2] Chinese Pharmaceutical API Industry Report, Market Research Future (2022).
[3] WuXi AppTec Capabilities Brochure, WuXi (2023).
[4] Chinese API GMP Certification Database, National Medical Products Administration (2023).
[5] Lipid-Modulating Conjugate API Development, Journal of Pharmaceutical Sciences, Vol. 111, 2022.