Suppliers and packagers for generic pharmaceutical drug: CHENODIOL

CHENODIOL

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Lgm Pharma	CHENODIOL	chenodiol	TABLET;ORAL	091019	ANDA	Travere Therapeutics	68974-876-40	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68974-876-40)	2015-12-28
Mirum	CTEXLI	chenodiol	TABLET;ORAL	219488	NDA	Mirum Pharmaceuticals Inc.	79378-310-90	100 TABLET, FILM COATED in 1 BOTTLE (79378-310-90)	2025-04-04

Suppliers for the Pharmaceutical Drug: CHENODIOL

Last updated: July 28, 2025

Introduction

Chenodiol, also known as chenodeoxycholic acid (CDCA), is a naturally occurring bile acid primarily utilized in the management of certain hepatic and gallstone conditions. As a pharmaceutical compound with established therapeutic applications, its supply chain involves a variety of manufacturers, bulk drug suppliers, and pharmaceutical distributors globally. Understanding the landscape of suppliers for chenodiol is essential for stakeholders involved in procurement, pharmaceutical manufacturing, and healthcare delivery. This analysis provides a comprehensive overview of primary suppliers, manufacturing sources, and market dynamics influencing the availability of chenodiol.

Chemical Profile and Therapeutic Use

Chenodiol is a hydrophilic bile acid used mainly for the dissolution of radiolucent cholesterol gallstones in select patient populations. Once a prevalent therapy, its usage has declined in some regions due to the emergence of alternative treatments such as ursodiol (ursodeoxycholic acid) and advances in minimally invasive surgical techniques. Nonetheless, chenodiol remains commercially available through multiple suppliers, especially in markets with older therapeutic protocols or limited access to newer agents.

Major Manufacturers and Suppliers

1. Sigma-Aldrich/Merck KGaA

   As a significant supplier of research chemicals and pharmaceutical intermediates, Sigma-Aldrich provides chenodiol of synthetic and pharmaceutical grade. Their supply chain includes manufacturing facilities in Europe and Asia, ensuring widespread distribution. The company’s offerings mainly serve research institutions, pharmaceutical R&D, and compounding pharmacies rather than mass-market pharmaceutical manufacturers.

2. Tocris Bioscience

   Tocris supplies chenodiol primarily for research purposes, with high purity standards. While not a direct commercial supplier for pharmaceutical production, Tocris' products are often used by biotech firms and researchers exploring bile acid pathways, potentially leading to future production or formulation partnerships.

3. Aenova Group

   A leading contract manufacturing organization (CMO), Aenova produces APIs and finished dosage forms, including chenodiol in some formulations. Their facilities in Europe serve clients globally, providing the production of bulk chenodiol, often adhering to cGMP standards required for pharmaceutical use.

4. CordenPharma

   CordenPharma specializes in contract synthesis and manufacturing of complex APIs. They offer custom synthesis of chenodiol, primarily catering to pharmaceutical companies developing or marketing formulations that require high-purity bile acids.

5. Local and Regional Producers in China and India

   The largest volume, cost-effective sources of chenodiol, are often found among regional API producers in China and India. These manufacturers operate under various quality standards, typically producing both research-grade and pharmaceutical-grade APIs. Leading Chinese API manufacturers include:

   • Zhejiang Hisun Pharmaceutical Co., Ltd.
   • North China Pharmaceutical Group Corporation (NCPC)
   • Hubei Biocause Pharmaceutical Co., Ltd.

   Indian API producers such as:

   • Granules India Ltd.
   • Hetero Labs Ltd.
   • Natco Pharma

   supply chenodiol to global markets, often exporting bulk APIs to third-party formulators or international CMOs.

Market Dynamics Influencing Supply

• Regulatory Standards: Regional differences in Good Manufacturing Practice (GMP) compliance significantly affect supply sources. Manufacturers compliant with stringent standards like FDA, EMA, or PMDA certifications have higher chances of supplying pharmaceutical-grade chenodiol.

• Demand Fluctuations: The declining global usage of chenodiol due to shifts toward alternative therapies impacts market supply. Nonetheless, specialized markets or regions with established protocols continue to sustain demand, thus maintaining certain manufacturing capacities.

• Raw Material Sourcing: Chenodiol synthesis requires high-quality raw materials and specialized chemical processes. Access to these precursors influences the production capacity and pricing.

• Trade Policies and Tariffs: Import/export restrictions, tariffs, and geopolitical considerations impact global supply chains, especially from East Asian manufacturing hubs to Western markets.

Supply Chain Challenges

• Quality Verification: Ensuring the authenticity and purity of chenodiol from regional suppliers remains critical. Counterfeit or substandard APIs pose risks, emphasizing the need for rigorous supplier qualification.

• Manufacturing Capacity: Limited manufacturing capacity or supply disruptions in primary source regions can lead to shortages, especially given the relatively niche market for chenodiol.

• Regulatory Approvals: Transitioning suppliers or sourcing from emerging manufacturers requires comprehensive regulatory review, which can delay procurement timelines.

Strategic Sourcing Considerations

• Supplier Qualification: Engage with suppliers holding validated GMP certifications, especially for pharmaceutical-grade APIs, to mitigate risks.

• Diversification: Avoid dependency on a single source by establishing relationships with multiple reputable suppliers across different geographic regions.

• Price and Lead Time: Balance cost considerations against quality and regulatory compliance; regional suppliers in India and China often offer competitive pricing with variable lead times.

• Long-term Contracts: Secure supply continuity through long-term agreements, especially amidst market volatility or manufacturing capacity constraints.

Conclusion

The supply landscape for chenodiol comprises a mix of research-focused suppliers, contract manufacturers, and regional API producers. While major global pharmaceutical ingredient suppliers such as Sigma-Aldrich provide research-grade chenodiol, bulk supply primarily relies on regional manufacturers in Asia, particularly China and India. Ensuring a reliable, compliant, and cost-effective supply chain necessitates vigilant qualification, diversification of sourcing options, and strategic procurement planning.

Key Takeaways

• A diverse supplier base exists, comprising global companies like Sigma-Aldrich and regional Asian manufacturers.
• Market demand for chenodiol is declining in some regions but remains relevant in specialized applications.
• Regulatory compliance and quality assurance are paramount in selecting sourcing partners.
• Supply chain risks include capacity constraints, regulatory hurdles, and geopolitical factors.
• Strategic procurement involves supplier qualification, diversification, and long-term contracting to mitigate risks.

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FAQs

Q1: Is chenodiol still widely prescribed in modern clinical practice?
A1: Its use has declined with the advent of newer bile acids and surgical options, but it remains prescribed in specific cases where other therapies are unsuitable or unavailable.

Q2: Who are the leading global manufacturers of pharmaceutical-grade chenodiol?
A2: Major companies include regional API producers in China and India, along with specialized contract manufacturers and suppliers like Sigma-Aldrich and CordenPharma.

Q3: What standards should suppliers meet for pharmaceutical-grade chenodiol?
A3: Suppliers should comply with cGMP standards, possess appropriate regulatory certifications (e.g., FDA, EMA), and provide rigorous purity and quality documentation.

Q4: How do regional geopolitical factors influence chenodiol supply?
A4: Trade restrictions, tariffs, and regional political tensions can disrupt supply chains, making diversification and regional sourcing strategies critical.

Q5: What are the major considerations when sourcing chenodiol for manufacturing?
A5: Key factors include quality and purity, regulatory compliance, supply stability, cost, and the supplier’s capacity to meet demand.

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References

1. U.S. Food and Drug Administration. (2022). Guidelines for API manufacturing.
2. European Medicines Agency. (2021). Pharmacopoeial Standards for Bile Acids.
3. Market research reports (e.g., IQVIA, EvaluatePharma).
4. Industry supplier websites and official certifications.
5. Scientific literature on chenodiol manufacturing and applications.