Bulk Pharmaceutical API Sources for CHOLIC ACID

Bulk Pharmaceutical API Sources for CHOLIC ACID

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		ik``h@@DNJ_HidhiiDhjdhiBmmVCFkU{ZjjjjjjjjjkUIdITzPlUMf[[P@
Sigma-Aldrich		C1129_SIGMA
NovoSeek		221493
Vitas-M Laboratory		STK801993
MolPort		MolPort-003-892-613

Bulk Active Pharmaceutical Ingredient (API) Sources for Cholic Acid

Last updated: August 2, 2025

Introduction

Cholic acid, a primary bile acid synthesized in the liver from cholesterol, plays a vital role in lipid digestion and absorption. Its therapeutic applications include treatment of certain inherited liver disorders and cholestatic diseases. As a key API in pharmaceutical formulations, sourcing high-quality cholic acid is critical for manufacturers and stakeholders within the pharmaceutical supply chain. This article explores global bulk API suppliers specializing in cholic acid, emphasizing quality, regulatory compliance, and market dynamics.

Market Overview of Cholic Acid APIs

The global supply of cholic acid as an API is characterized by a limited number of specialized manufacturers, primarily due to the complexity of synthesis, stringent purity standards, and regulatory requirements. The demand is driven by its use in treatments such as primary biliary cirrhosis, certain metabolic disorders, and as a component in formulations designed for specific liver conditions. The API market is dominated by companies focusing on high-grade, pharmaceutical-registered cholic acid, sourced predominantly from China, India, and select European manufacturers.

Key API Manufacturers and Suppliers

1. Chinese Manufacturers

China remains the dominant producer of bulk cholic acid due to its established pharmaceutical raw materials industry. These suppliers offer competitive pricing and large-scale production capabilities.

a. Shandong Qilu Pharmaceutical Co., Ltd.

• Overview: Recognized for its comprehensive portfolio of bile acids, including cholic acid. The company holds Good Manufacturing Practice (GMP) certificates and adheres to international quality standards.
• Strengths: Reliable supply chain, extensive R&D capabilities, and consistent product quality.
• Certifications: GMP, ISO 9001, and ISO 14001.
• Market Focus: Supplies primarily to Asia, with increasing exports to Europe and North America.

b. Zhejiang Medicine Co., Ltd.

• Overview: One of China's leading pharmaceutical companies with integrated bile acid manufacturing processes.
• Strengths: Large production capacity, rigorous quality assurance, compliance with international standards.
• Certifications: GMP, ISO.
• Key Advantages: Ability to meet bulk demand for cholic acid with high purity levels suitable for pharmaceutical APIs.

c. Tianjin Pharmaceutical Group Co., Ltd.

• Overview: A prominent manufacturer with extensive experience in botanical and chemical APIs, including cholic acid.
• Strengths: Economical pricing, robust supply chain, and adherence to quality control protocols.
• Market Position: Focused mainly on the Asian market with growing global presence.

2. Indian API Manufacturers

India's pharmaceutical industry features companies with significant expertise in bile acid synthesis and derivative production.

a. Aarti Drugs Ltd.

• Overview: A major Indian API producer offering pharmaceutically approved cholic acid.
• Strengths: Competitive pricing, GMP compliance, and strong regulatory track record.
• Certifications: WHO-GMP, ISO 9001, and US FDA approvals for certain facilities.
• Application: Supplies to global markets, including North America, Africa, and Southeast Asia.

b. Neelkanth Healthcare

• Overview: Specializes in natural and synthetic bile acids, including high-purity cholic acid.
• Strengths: Focus on quality consistency, supply stability, and tailor-made specifications.
• Regulatory Accreditation: Compliant with international standards, aiming for global pharmaceutical approvals.

3. European and North American Suppliers

While fewer in number, these suppliers point to higher regulatory standards and stringent quality control.

a. Liaoning University of Traditional Chinese Medicine (LUTCM) Bioengineering Co., Ltd. (China)

• Overview: Focuses on herbal and natural bile acids but expanding into chemically synthesized APIs.
• Reputation: Known for research-driven production methods and quality assurance.

b. Specialty Chemical Suppliers in Europe

• Limited dedicated European producers focus on high-purity cholic acid; instead, they primarily distribute Chinese-derived APIs complying with GMP standards.

4. Contract Manufacturing Organizations (CMOs)

Several CMOs worldwide offer custom synthesis and large-scale manufacturing of cholic acid APIs, emphasizing quality, regulatory compliance, and validation.

• Notable Players: Recipharm (Sweden), BiogenX (India), and others with capabilities for API development and manufacturing under GMP standards.

Quality and Regulatory Considerations

API suppliers must demonstrate consistent conformances to pharmacopeial standards, such as USP (United States Pharmacopeia), EP (European Pharmacopeia), or BP (British Pharmacopoeia). Purity typically exceeds 98%, with low levels of residual solvents and contaminants. Additionally, Certificate of Analysis (CoA), batch documentation, and stability data are essential to verify API quality.

Supplier GMP certification, regulatory approvals, and comprehensive quality assurance programs are critical selection criteria, especially for APIs intended for marketed formulations in highly regulated markets. Moreover, suppliers adhering to internationally recognized quality standards can support accelerated registration processes.

Supply Chain Considerations

In considering sources, stakeholders should evaluate the robustness of the supply chain, price stability, and capacity to meet bulk demands. The COVID-19 pandemic exposed vulnerabilities in supply chain resilience, underscoring the need for diversified sourcing strategies.

Clear communication regarding lead times, batch consistency, and documentation accuracy influences procurement success. Additionally, suppliers with long-standing regulatory compliance track records are preferred to minimize approval delays.

Emerging Trends and Market Dynamics

The API market for cholic acid is witnessing shifts driven by increased regulatory scrutiny, the push for sustainable manufacturing, and market expansion into emerging economies. Automation, process intensification, and green chemistry practices are being adopted by leading producers to reduce environmental impact and improve yields.

Furthermore, pharmaceutical companies are seeking APIs with verified bioequivalence, consistent purity, and comprehensive documentation to ensure seamless regulatory approvals across regions.

Conclusion

Securing a reliable bulk API source for cholic acid necessitates evaluating supplier reputation, manufacturing capacity, regulatory compliance, and quality assurance processes. The most prominent sources include Chinese and Indian manufacturers with robust GMP certification, capable of delivering high-quality APIs at competitive prices. European and North American suppliers, albeit fewer, offer high standards that may align better with stringent regulatory requirements.

Key Takeaways

• The primary sources of bulk cholic acid API are China and India, offering substantial capacity and competitive pricing.
• Stringent quality standards, including GMP certification and pharmacopeial compliance, are critical differentiators.
• Diversification of suppliers mitigates supply chain risks, especially amid global disruptions.
• Collaborating with CMOs with proven regulatory track records can expedite validation and approval processes.
• Sustainable and green manufacturing practices are increasingly influencing supplier selection in the API market.

FAQs

1. What are the main factors to consider when selecting a cholic acid API supplier?
Quality assurance (GMP compliance), regulatory certifications, purity levels, manufacturing capacity, supply chain reliability, and cost-effectiveness are vital.

2. Are Chinese cholic acid APIs suitable for regulated markets?
Yes. Chinese suppliers with GMP certification, pharmacopeial compliance, and comprehensive documentation can successfully supply APIs for regulated markets.

3. How does the purity level of cholic acid APIs impact pharmaceutical applications?
Higher purity levels (>98%) minimize impurities that could affect efficacy, safety, and regulatory approval, making consistent purity critical.

4. What role do contract manufacturing organizations play in cholic acid supply?
CMOs provide custom synthesis, scale-up, and manufacturing services, ensuring quality control, regulatory compliance, and supply stability.

5. How do recent global supply chain disruptions influence API sourcing strategies?
Stakeholders are increasing supplier diversification, building inventory buffers, and engaging with reputable manufacturers to enhance resilience.

References

[1] Market intelligence reports on bile acids and APIs.

[2] Chinese API manufacturers' official certifications and quality standards.

[3] Indian pharmaceutical industry reports on API production capacities.

[4] European Pharmacopoeia guidelines and compliance frameworks.