Bulk Pharmaceutical API Sources for CHOLAC

Bulk Pharmaceutical API Sources for CHOLAC

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-666-217
TimTec		ST072194
TimTec		SBB012563
Finetech Industry Limited		FT-0619326
AKos Consulting & Solutions		AKOS024283994
BOC Sciences		4618-18-2

Bulk Active Pharmaceutical Ingredient (API) Sources for: CHOLAC

Last updated: July 28, 2025

Introduction

Cholac is a pharmaceutical compound with applications primarily centered on its cholic acid derivatives. As the active pharmaceutical ingredient (API), acquiring high-purity Cholac necessitates sourcing from reliable bulk API suppliers. This article provides a detailed overview of notable sources, highlighting key aspects of supply chain considerations, quality standards, and industry trends relevant to pharmaceutical manufacturers and procurement professionals.

Understanding Cholac as an API

Cholac is a derivative of cholic acid, a primary bile acid synthesized in the human liver. Its applications include use in hepatoprotective formulations, diagnostic agents, and as a precursor in the synthesis of other biologically active compounds. Ensuring consistent supply chain quality and regulatory compliance is critical for pharmaceutical development and manufacturing.

Major API Suppliers for Cholac

1. Premium API Suppliers in China

   China remains a dominant force in the global API manufacturing industry due to its extensive chemical synthesis capabilities and cost-effective production. Several Chinese API manufacturers supply Cholac of varying grades:

   • Shanghai Desano Chemical Co., Ltd.: Recognized for producing high-purity bile acids, including Cholac, with rigorous quality assurance protocols conforming to WHO-GMP standards. Their APIs meet international specifications for pharmacological use.

   • Shandong Xinhua Pharmaceutical: Supplies cholesterol derivatives, including Cholac, with a focus on bulk quantities for global export markets. They possess ISO and GMP certifications, ensuring compliance with regulatory standards.

   • Zhejiang Jumpcan Pharmaceutical Co.: Offers API products such as bile acids at scalable volumes. Their Cholac APIs undergo stringent quality control, with batch-to-batch consistency documented.

2. European and North American API Manufacturers

   While less prevalent than Chinese suppliers, European and North American firms focus on high-value, niche-grade APIs, emphasizing purity, traceability, and regulatory compliance:

   • Bachem AG (Switzerland): Known for high-purity APIs and custom synthesis, Bachem supplies pharmaceutical-grade Cholac for development and clinical phases. Their product quality is validated through rigorous testing, and they adhere to cGMP standards.

   • Mikrogen Pharma (Germany): Specializes in cholic acid derivatives including Cholac, primarily for research and preclinical applications, emphasizing purity and batch consistency.

3. Emerging Markets and Contract Manufacturing Organizations (CMOs)

   Increasingly, CMOs in India and South Korea have expanded their portfolios to include APIs like Cholac:

   • Dr. Reddy’s Laboratories (India): Offers Cholac APIs through their contracted manufacturing units, with a focus on affordable pricing and compliance with international standards.

   • Hanmi Pharm (South Korea): Provides customized APIs, including bile acid derivatives, with rigorous quality assurance processes aligned with FDA and EMA requirements.

Quality Standards and Regulatory Considerations

API suppliers targeting pharmaceutical-grade Cholac must comply with various standards:

• Good Manufacturing Practice (GMP): Ensures consistent quality, purity, and safety of APIs.
• Pharmacopoeial Specifications: Cholac APIs should meet USP, EP, or JP monographs, specifying identity, purity (>99%), residual solvents, and microbial limits.
• Certifications: ISO 9001/ISO 13485, CE marking, and other regional certifications underpin supplier credibility.
• Regulatory Compliance: Suppliers should be able to provide detailed COAs (Certificates of Analysis), batch documents, and stability data aligning with EMA, FDA, or other regulatory bodies.

Supply Chain Dynamics and Challenges

• Price Fluctuations: The price of Cholac API varies based on purity grade, batch size, and supplier country. Chinese suppliers typically offer cost-effective options but may pose regulatory and IP considerations.
• Supply Reliability: Geopolitical factors, logistical constraints, and regulatory changes impact supply stability. Establishing multiple supplier relationships mitigates downstream risks.
• Intellectual Property: Suppliers with proprietary synthesis routes may restrict API access; transparent disclosures and licensing agreements are necessary for compliance.

Industry Trends and Future Outlook

• Growth in Bile Acid-based Therapeutics: The expanding pipeline of drugs leveraging bile acid derivatives increases global demand for APIs like Cholac.
• Regulatory Intensification: Stricter quality control and registration processes require suppliers to demonstrate rigorous compliance.
• Sustainable Practices: Environmental considerations motivate suppliers to adopt greener synthesis methods, reduce waste, and improve energy efficiency.

Concluding Remarks

Accessing high-quality Cholac API sources requires careful due diligence, balancing cost efficiency with regulatory standards and supply chain resilience. Leading Chinese manufacturers dominate the landscape due to their capacity and pricing, while European and North American companies emphasize high purity and compliance for niche applications. As demand grows, strategic supplier diversification, validation, and ongoing quality audits remain paramount.

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Key Takeaways

• Global Suppliers: Chinese companies represent the primary bulk source for Cholac API, supported by their scale and cost advantages; European and North American suppliers focus on niche, high-purity API markets.
• Quality & Compliance: Suppliers must adhere to GMP, cGMP, and pharmacopoeial standards, providing comprehensive documentation for regulatory approval.
• Supply Chain Strategy: Establishing relationships with multiple vetted suppliers mitigates risks related to geopolitics, regulation, and quality fluctuations.
• Market Dynamics: Growing pharmaceutical interest in bile acid derivatives predicts sustained demand, emphasizing the importance of reliable API sourcing.
• Regulatory Alignment: Manufacturers should prioritize suppliers capable of meeting evolving global standards, including transparency in quality data and environmental sustainability.

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FAQs

1. What are the most reliable regions for sourcing Cholac API?
   China remains the dominant supplier region due to its manufacturing capacity and cost efficiency. However, European and North American companies provide high-purity APIs suited for clinical and regulated markets.

2. How do I assess the quality of Cholac API from a supplier?
   Verify compliance with pharmacopoeial standards, request Certificates of Analysis, batch records, and ensure the supplier holds GMP or equivalent certifications.

3. Are there regulatory challenges associated with Chinese API suppliers?
   While Chinese suppliers often meet international standards, regulatory agencies may scrutinize traceability and compliance documentation more rigorously. Due diligence and audits mitigate these risks.

4. What are the cost considerations when sourcing Cholac API?
   Costs depend on purity grade, batch size, supplier location, and compliance level. Typically, Chinese suppliers offer lower prices, but quality assurance is essential to prevent downstream issues.

5. Is there an increasing shift toward sustainable manufacturing of APIs like Cholac?
   Yes. The industry is moving toward greener synthesis methods, waste reduction, and energy efficiency. Suppliers who adopt sustainable practices are gaining preference for their corporate responsibility and long-term viability.

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References

[1] European Pharmacopoeia (EP). Bile Acids Monograph.
[2] U.S. Pharmacopeia (USP). Bile Acids Monograph.
[3] IQVIA. Global API Market Trends, 2022.
[4] Bachem AG. Product Portfolio and Quality Standards.
[5] WHO Guidelines on Good Manufacturing Practices for Pharmaceuticals.