Suppliers and packagers for generic pharmaceutical drug: CHOLIC ACID

CHOLIC ACID

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mirum	CHOLBAM	cholic acid	CAPSULE;ORAL	205750	NDA	Manchester Pharmaceuticals, LLC	45043-001-02	90 CAPSULE in 1 BOTTLE (45043-001-02)	2015-03-31
Mirum	CHOLBAM	cholic acid	CAPSULE;ORAL	205750	NDA	Manchester Pharmaceuticals, LLC	45043-002-02	90 CAPSULE in 1 BOTTLE (45043-002-02)	2015-03-31
Mirum	CHOLBAM	cholic acid	CAPSULE;ORAL	205750	NDA	Mirum Pharmaceuticals Inc.	79378-001-02	90 CAPSULE in 1 BOTTLE (79378-001-02)	2025-05-09

Suppliers for the Pharmaceutical Drug: Cholic Acid

Last updated: July 29, 2025

Introduction

Cholic acid, a primary bile acid synthesized in the liver, is a critical component in treating specific cholestatic liver diseases and malabsorption syndromes. As a pharmaceutical-grade compound, cholic acid must adhere to stringent quality standards, and its supply chain involves a range of suppliers, including chemical manufacturers, raw material producers, and distributors. This article profiles prominent suppliers globally, evaluates market dynamics, and highlights factors influencing sourcing decisions for pharmaceutical firms.

Overview of Cholic Acid in Pharmaceuticals

Cholic acid (CAS Number 79-25-6) plays a pivotal role in therapies for inborn errors of bile acid synthesis, such as cerebrotendinous xanthomatosis, and as part of choleretic formulations. Its biosynthesis involves complex processes, but pharmaceutical applications primarily rely on chemically synthesized or semisynthetically derived cholic acid, ensuring purity and consistency for medical use.

Global Suppliers and Manufacturers

1. IDM (Indukern Medicine) and Related Specialized Suppliers

Several companies focus on the production of sterile and pharmaceutical-grade bile acids, including cholic acid. IDM, a leader in the pharmaceutical raw material market, supplies high-purity cholic acid to manufacturers worldwide. Their offerings conform to pharmaceutical standards (e.g., USP, EP, JP), ensuring safety and efficacy.

2. Wego Chemical Group

Wego Chemical Group is a prominent supplier of chemical raw materials for pharmaceutical applications. They stock cholic acid in bulk quantities, emphasizing pharmaceutical grade, purity, and regulatory compliance. Their extensive distribution network facilitates global access, especially to markets in North America and Asia.

3. Alfa Aesar (part of Thermo Fisher Scientific)

Alfa Aesar supplies chemical intermediates, including cholic acid, with a focus on research and pharmaceutical manufacturers. Their products meet rigorous quality standards, offering both analytical and bulk quantities suitable for drug formulation.

4. TCI Chemicals

Tokyo Chemical Industry (TCI) provides high-quality cholic acid, catering to research institutions and manufacturing companies. Their compliance with international pharmaceutical standards makes them a reliable source for pharmaceutical-grade cholic acid.

5. Chengdu dahongjie Biological Technology Co., Ltd.

Based in China, this manufacturer specializes in natural and synthetic bile acids, including cholic acid. They emphasize scalable production and compliance with global regulatory standards, positioning themselves as a key supplier in the Asian market.

6. Phytochemicals & Natural Product Suppliers

Some suppliers derive cholic acid semi-synthetically from natural sources or from microbial fermentation processes. These producers focus on producing biogenic and environmentally sustainable cholic acid, catering to niche markets emphasizing natural or biologically derived compounds.

Market Dynamics and Supply Chain Considerations

• Regulatory Compliance: Suppliers must meet international standards like USP, EP, JP, and cGMP regulations to ensure drug safety and efficacy.
• Manufacturing Capacity: The capacity of producers in China and India significantly influences supply stability and pricing.
• Raw Material Availability: The synthesis or extraction raw materials impact production costs and lead times.
• Quality Certifications: Certifications such as ISO, GMP, and others are crucial markers of supplier credibility.
• Pricing Trends: Fluctuations are driven by raw material costs, regulatory changes, and geopolitical factors affecting international trade.

Challenges in Supply Chain

• Supply Disruptions: Manufacturing interruptions, political issues, and pandemic-related disturbances have occasionally hindered raw material availability and distribution.
• Regulatory Hurdles: Variations in regulatory standards across regions can complicate importing and exporting processes.
• Quality Assurance: Ensuring consistent quality across batches remains a priority, demanding rigorous supplier qualification processes.

Emerging Trends and Opportunities

• Vertical Integration: Manufacturers are increasingly pursuing in-house synthesis or control over raw material sourcing to mitigate supply risks.
• Biotechnological Innovation: Advances in microbial fermentation for bile acid production could shift traditional chemical synthesis pathways toward more sustainable processes.
• Regional Market Expansion: Increasing demand in Asia promises growth for suppliers in China, India, and Southeast Asia, especially with the expansion of local regulatory frameworks supporting pharmaceutical importation.

Conclusion

For pharmaceutical companies sourcing cholic acid, selecting a reliable supplier hinges on regulatory compliance, manufacturing capacity, quality standards, and geopolitical stability. Market leaders like IDM, Wego, Alfa Aesar, and TCI stand out for their extensive product offerings and compliance with international standards. Meanwhile, Chinese and Indian manufacturers play vital roles, especially in cost-effective bulk supply, despite potential regional regulatory hurdles.

Key Takeaways

• Qualified suppliers must align with international pharmaceutical standards (USP, EP, cGMP).
• Price competitiveness often correlates with manufacturing location—China and India dominate bulk supply.
• Supply chain resilience depends on diversified sourcing and supplier qualification.
• Emerging biotechnologies may reshape future supply dynamics toward more sustainable production.
• Close monitoring of regulatory environments is essential for uninterrupted supply.

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FAQs

Q1. What quality standards should pharmaceutical companies verify when sourcing cholic acid?
Pharmaceutical-grade cholic acid should meet standards such as USP, EP, or JP, alongside cGMP compliance, ensuring safety, purity, and efficacy.

Q2. Are natural or semi-synthetic cholic acids available for pharmaceutical use?
Yes. Some suppliers produce biogenic cholic acid derived from microbial fermentation, appealing to markets emphasizing natural or environmentally sustainable products.

Q3. Which regions dominate the production of pharmaceutical-grade cholic acid?
China and India are leading suppliers due to lower manufacturing costs and expanding capacity, complemented by established global chemical companies in North America and Europe.

Q4. How do supply chain disruptions affect the availability of cholic acid?
Disruptions can cause delays and price volatility. Manufacturers mitigate this risk through supplier diversification and maintaining strategic inventories.

Q5. What future trends could influence the supply of cholic acid?
Biotechnological innovations in microbial synthesis and increasing regional regulatory support are expected to influence supply patterns, potentially enhancing sustainability and stability.

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References

1. U.S. Pharmacopeia. Monographs on Bile Acids.
2. European Pharmacopoeia. Cholic Acid Monograph.
3. Alfa Aesar. Product catalog for pharmaceutical-grade bile acids.
4. Wego Chemical Group. Product specifications and supply details.
5. TCI Chemicals. Product data sheets and regulatory compliance information.