Bulk Pharmaceutical API Sources for ACTIGALL

Bulk Pharmaceutical API Sources for ACTIGALL

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		U5127_SIGMA
TCI (Tokyo Chemical Industry)		U0030
Molport		MolPort-001-794-630

Bulk Active Pharmaceutical Ingredient (API) Sources for ACTIGALL

Last updated: July 28, 2025

Introduction

Actigall, the brand name for ursodiol (ursodeoxycholic acid), is a pharmaceutical agent primarily used to dissolve gallstones and treat primary biliary cholangitis (PBC). Its clinical efficacy hinges on the purity, stability, and quality of the active pharmaceutical ingredient (API). As demand for ursodiol escalates, identifying reliable bulk API suppliers becomes Critical for pharmaceutical manufacturers, distributors, and healthcare providers. This report provides a comprehensive analysis of current and emerging sources for bulk ursodiol API, highlighting manufacturing regions, supplier reputations, regulatory considerations, and supply chain dynamics.

Overview of Ursodiol (Ursodeoxycholic Acid)

Ursodiol is a naturally occurring bile acid found in small amounts in human and bear bile, and it can be synthesized chemically for pharmaceutical purposes. It exerts its therapeutic effects by reducing the cholesterol content of gallstones and exerting immunomodulatory actions in PBC. The global market for ursodiol is driven by increasing cases of gallstone disease and chronic liver conditions, with key markets including North America, Europe, and Asia-Pacific.

Global API Manufacturing Landscape

The production of ursodiol API is concentrated primarily in regions with established pharmaceutical manufacturing infrastructure, notably in China, India, Germany, and the United States. China and India are significant producers of generic API owing to cost advantages and large-scale manufacturing capabilities. European and North American companies tend to focus on high-quality, GMP-compliant production with integrated quality assurance systems.

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Key API Suppliers for ACTIGALL

1. Chinese API Manufacturers

a. Jiangsu Hengrui Medicine Co., Ltd.

Jiangsu Hengrui is a leading Chinese pharmaceutical enterprise with a robust API manufacturing platform, including ursodiol. The company is GMP-certified and maintains stringent quality controls aligned with international standards. Their API products are widely exported and used in various generic formulations globally.

b. Zhejiang Jianfeng Pharmaceutical Co., Ltd.

Specialized in bile acid derivatives, Jianfeng offers ursodiol API conforming to pharmacopoeial standards. Their manufacturing facilities are GMP-certified, and they have a reputation for consistent quality.

c. Shandong Win Health Pharmaceutical Co., Ltd.

A notable API producer with a focus on gastrointestinal agents, Win Health provides bulk ursodiol that complies with USP and BP standards, emphasizing cost-effective supply for generic drug manufacturers.

2. Indian API Manufacturers

a. Suven Life Sciences Ltd.

Suven is a prominent Indian pharmaceutical company manufacturing ursodiol API, certified by WHO-GMP and other regulatory bodies. They supply to both domestic and international markets, with a focus on quality and reliable delivery.

b. Natco Pharma Limited

Natco offers ursodiol API with quality certifications, including ISO and GMP. Their manufacturing processes incorporate modern synthesis routes ensuring high purity levels.

c. Mylan Laboratories (Now part of Viatris)

Viatris’ Indian facilities produce ursodiol API following stringent quality norms aligned with global standards, catering to large-scale demand.

3. European and North American Suppliers

a. Albemarle Corporation

Albemarle supplies specialty chemicals and APIs, including ursodiol, with a focus on high standards compliance and regulatory approvals such as FDA and EMA registrations.

b. Solara Active Pharma Sciences

An Indian-origin company with a global presence, Solara provides bulk ursodiol API compliant with many pharmacopoeial standards and holds regulatory approvals for export.

c. Ind-Pharma

A US-based API manufacturer holding DEA and FDA certifications, they produce ursodiol leveraging advanced synthetic methods to ensure purity and batch-to-batch consistency.

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Regulatory and Quality Considerations

API sources for ACTIGALL must comply with stringent regulatory standards. Manufacturing facilities should adhere to Good Manufacturing Practices (GMP), with certifications from authorities such as the FDA (US), EMA (Europe), or WHO (Global). Validation of the synthesis process, extensive analytical testing, and stability data underpin the quality assurance processes.

Due diligence includes reviewing supplier audits, batch record documentation, and third-party quality assessments. Suppliers with a history of regulatory compliance are preferred to mitigate risks associated with substandard APIs, which could lead to patent infringements, quality failures, and legal liabilities.

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Supply Chain Dynamics and Challenges

Supply security is a significant concern, with geopolitical issues, raw material availability, and regulatory changes impacting API supply chains. Chinese and Indian manufacturers dominate the ursodiol API market, with recent geopolitical tensions emphasizing the necessity of diversified sourcing strategies.

Capacity constraints and quality fluctuations can disrupt supply. Pharmaceutical companies often establish long-term contracts with multiple approved suppliers to ensure continuous availability for ACTIGALL formulations. Moreover, the adoption of dual sourcing strategies aligns with regulatory compliance and risk mitigation.

Emerging Trends

• Adoption of advanced synthetic methodologies to improve yield and purity.
• Increasing emphasis on sustainable manufacturing practices.
• Growth of regional API production capacities to reduce dependency on imports.
• Enhanced quality control measures leveraging analytical techniques such as HPLC, NMR, and MS.

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Conclusion

The global landscape for bulk ursodiol API is dynamic, with significant contributions from China, India, Europe, and North America. Leading manufacturers, such as Jiangsu Hengrui, Zhejiang Jianfeng, Suven Life Sciences, and Albemarle, offer high-quality APIs compliant with international standards. Importantly, pharmaceutical companies must prioritize supply chain resilience, regulatory adherence, and quality assurance in selecting API sources for ACTIGALL.

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Key Takeaways

• China and India dominate the bulk ursodiol API market due to cost efficiency and manufacturing capacity; however, European and North American suppliers offer high-quality options suitable for stringent regulatory environments.
• Ensuring API suppliers are GMP-certified and possess regulatory certifications (FDA, EMA, WHO-GMP) is critical in maintaining product quality and compliance.
• Long-term supply agreements and diversification strategies mitigate risks related to geopolitical, logistical, or regulatory disruptions.
• Continuous monitoring of manufacturing practices, analytical testing, and quality certifications underpin reliable API sourcing.
• The evolving landscape emphasizes innovation in synthesis, sustainability, and regional manufacturing to meet global demand sustainably.

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FAQs

1. What are the primary regions supplying ursodiol API for ACTIGALL?
China and India are the leading suppliers, with European and North American companies providing high-quality options for markets with strict regulatory requirements.

2. How can companies validate the quality of bulk ursodiol API?
Through review of GMP certifications, batch testing reports, analytical data (HPLC, NMR), and regulatory compliance documentation from suppliers.

3. Are there specific regulatory considerations when sourcing ursodiol API?
Yes. Suppliers must hold certifications like GMP, FDA registration, or WHO-GMP approval. Batch documentation and stability data are essential for compliance.

4. What are the risks associated with sourcing ursodiol API from variable suppliers?
Quality inconsistencies, regulatory non-compliance, supply disruptions, and potential patent issues can jeopardize product safety and timelines.

5. Is regional diversification advisable for API sourcing?
Yes. Diversification reduces dependency on a single region, minimizes supply chain risks, and ensures steady access to high-quality API.

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References

1. “Ursodiol (Ursodeoxycholic Acid) API Market Analysis,” PharmaMarkets, 2022.
2. “Global API Manufacturing Overview,” International Pharmacopoeia, WHO, 2021.
3. “Supplier Certifications and Quality Standards,” US FDA, 2023.
4. “Emerging Trends in API Synthesis,” Chemical & Pharmaceutical Reviews, Vol. 15, 2022.
5. “Regulatory Guidelines for API Importation,” EMA Guidelines, 2023.