Bulk Pharmaceutical API Sources for ANTARA (MICRONIZED)

Bulk Pharmaceutical API Sources for ANTARA (MICRONIZED)

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		F6020_SIGMA
Molport		MolPort-002-887-051
Hangzhou APIChem Technology		AC-4227

Bulk Active Pharmaceutical Ingredient (API) Sources for: ANTARA (MICRONIZED)

Last updated: July 28, 2025

Introduction

Antara, the commercial name for Ursodiol (also known as ursodeoxycholic acid), is a pharmaceutical active used primarily in the treatment of gallstones and certain cholestatic liver diseases. Its micronized form enhances bioavailability, ensuring optimal therapeutic efficacy. As a critical component in pharmaceutical formulations, the sourcing of high-quality API for Antara (micronized Ursodiol) is essential for manufacturers aiming to meet stringent quality standards, regulatory compliance, and cost-effectiveness.

This article provides an in-depth analysis of potential bulk API sources for micronized Ursodiol, considering factors such as supplier reputation, quality assurance, manufacturing capabilities, regulatory compliance, and geopolitical considerations.

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Overview of Ursodiol (Antara) API

Ursodiol is a naturally occurring bile acid derived from the oxidation of cholic acid. Industrially, it is produced via chemical synthesis or microbial transformation processes, with the latter increasingly preferred for purity and environmental considerations. The API's micronized form involves milling and particle size reduction to improve solubility and bioavailability, a critical factor in pharmaceutical efficacy.

The API's manufacturing process must follow Good Manufacturing Practices (GMP) to ensure consistency, potency, and purity. The API specifications adhere to standards such as the United States Pharmacopeia (USP), European Pharmacopoeia (EP), or other relevant pharmacopeias.

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Leading Global API Manufacturers for Ursodiol

1. Johnson Matthey (UK)

Overview
Johnson Matthey is a recognized leader in pharmaceutical and fine chemicals manufacturing, with extensive capabilities in bile acids’ synthesis, including Ursodiol. They hold multiple GMP certifications and supply APIs globally. Their expertise encompasses both bulk API production and customized synthesis.

Strengths

• Proven compliance with international regulatory standards
• Robust quality control and extensive supply capacity
• Strong global distribution channels

Limitations

• Premium pricing due to high manufacturing standards
• Potential lead times due to complex production processes

2. Zhejiang NHU Co., Ltd. (China)

Overview
Zhejiang NHU is a major Chinese pharmaceutical excipients and API producer. They have a dedicated bile acids manufacturing unit capable of producing Ursodiol with high purity levels and process innovation aimed at cost efficiency.

Strengths

• Competitive pricing with significant scale of production
• Increasing global presence and certification upgrades
• ISO and GMP certifications

Limitations

• Regulatory perceptions may vary in certain markets due to regional standards
• Quality assurance programs are actively evolving to meet international key standards

3. Dalian Meilun Biotech Co., Ltd. (China)

Overview
Dalian Meilun Biotech is another Chinese API manufacturer specializing in bile acids and derivatives. They offer micronized Ursodiol in bulk, with adherence to GMP and multiple pharmacopeia standards.

Strengths

• Cost-effective sourcing options
• Proven capacity for large-scale manufacturing
• Active regulatory filings and certifications

Limitations

• Perceived variability in regulatory acceptance outside China
• Need for rigorous qualification processes for international markets

4. Zhejiang Taiwan Hopax Chemical Industry Co., Ltd. (Taiwan)

Overview
Known for producing pharmaceutical intermediates and APIs, this Taiwanese company supplies Ursodiol with high purity and consistent particle size specifications suitable for micronized formulations.

Strengths

• High-quality standards aligned with international pharmacopeias
• Strategic location enabling efficient logistics

Limitations

• Smaller scale compared to Chinese and Western counterparts
• Market presence primarily within Asia, requiring validation for Western markets

5. Lipomed AG (Switzerland)

Overview
Lipomed specializes in medicinal chemistry, GMP synthesis, and APIs, with a focus on high purity, low impurity profiles, and reliable supply for complex APIs like Ursodiol.

Strengths

• Focused on niche, high-quality APIs
• Strict adherence to GMP and pharmacopeial standards
• Strong regulatory expertise

Limitations

• Higher cost structure limiting price competitiveness
• Limited production scale relative to large Chinese API suppliers

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Key Considerations When Selecting API Suppliers for Micronized Ursodiol

Quality and Compliance

Robust quality assurance systems are paramount. Suppliers should have GMP certifications (FDA, EUGMP, etc.) and provide comprehensive analytical data, including HPLC purity, residual solvent profile, particle size distribution, microbial limits, and impurity profiles. Certificates of Analysis (CoA) must be readily available, with rigorous testing aligning with pharmacopeial standards.

Regulatory and Certification Landscape

For markets like the US and Europe, the API provider must demonstrate compliance with relevant quality and safety standards. Suppliers with established regulatory filings and global approvals streamline the registration process and minimize compliance risks.

Cost and Lead Time

Manufacturing costs vary across regions, with Chinese suppliers typically offering competitive pricing due to manufacturing efficiencies. However, lead times and logistics can influence supply chain stability. Evaluating supplier capacity to meet volume demands is vital.

Particle Size and Micronization Capabilities

The API must meet specifications for micronized Ursodiol, typically with particle sizes less than 10 microns. Suppliers should validate their micronization processes and provide particle size distribution data.

Supply Chain Resilience

A diversified supplier base reduces risks related to geopolitical factors, trade restrictions, or regional disruptions. Strategic partnerships with multiple reputable suppliers facilitate continuity.

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Emerging Trends and Alternative Sources

Microbial and Biotechnological Production

Novel microbial fermentation processes are gaining traction, offering potentially purer and more sustainable Ursodiol production pathways. Collaborations with biotech firms could enhance supply security and quality.

Regional Shifts

Increasingly, manufacturers are exploring suppliers from India and Southeast Asia, leveraging competitive pricing and expanding capacity. These regions are investing in quality infrastructure to meet international standards.

Strategic Sourcing Approaches

Many multinational pharmaceutical companies adopt dual sourcing strategies, pairing established Western suppliers with cost-effective Asian manufacturers to optimize cost and supply reliability.

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Regulatory and Quality Assurance Outlook

The API sourcing landscape for micronized Ursodiol is evolving alongside regulatory standards. Manufacturers should ensure their suppliers have ongoing quality validations, stability data, and regulatory clearances. Due diligence includes onsite audits, validation reports, and periodic review of supplier compliance status.

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Conclusion

The procurement of bulk Ursodiol API—particularly in micronized form—necessitates a thorough evaluation of multiple factors, including quality standards, regulatory compliance, manufacturing scale, particle size specifications, and supply chain robustness. Leading suppliers like Johnson Matthey and Lipomed guarantee high purity and regulatory compliance, albeit at a premium price point, while Chinese manufacturers such as Zhejiang NHU and Dalian Meilun offer cost-effective alternatives with increasing international acceptance.

Pharmaceutical companies must balance cost considerations with quality and regulatory requirements, often establishing resilient supply chains through multi-source procurement to safeguard against disruptions.

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Key Takeaways

• Quality assurance and compliance with GMP/pharmacopeial standards are non-negotiable when sourcing Ursodiol API.
• Regional diversity in suppliers reduces supply chain risks, with leading global and Asian manufacturers offering different advantages.
• Micronization capability must be verified with detailed particle size distribution data to ensure bioavailability.
• Regulatory landscape influences supplier selection, favoring those with proven approvals and filing histories in target markets.
• Emerging microbial and biotechnological processes could redefine Ursodiol production, offering sustainability and purity benefits in the future.

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FAQs

1. What are the most reliable sources for bulk Ursodiol API?
Leading global chemical suppliers such as Johnson Matthey, Lipomed AG, and reputable Chinese manufacturers like Zhejiang NHU and Dalian Meilun are considered reliable due to their compliance with international GMP standards and proven capacity for high-quality production.

2. How important is particle size specification for micronized Ursodiol?
Very important. Micronization enhances bioavailability; suppliers must demonstrate particle sizes less than 10 microns with consistent distribution to meet therapeutic requirements.

3. Are there differences between Chinese and Western Ursodiol API manufacturers?
Yes. Western manufacturers typically have stricter regulatory approvals and higher validation standards, often resulting in higher costs. Chinese suppliers offer competitive pricing with increasing compliance, but due diligence is critical to ensure quality.

4. How do regulatory considerations impact API sourcing?
Suppliers must have GMP certifications (e.g., FDA, EUGMP), quality certificates, and registration alignments to facilitate market approvals and ensure the API meets the required pharmacopeial standards.

5. What are emerging trends in Ursodiol API manufacturing?
Microbial fermentation and biotechnological processes are emerging as sustainable, high-purity alternatives. Additionally, regional supply diversification is growing to enhance resilience.

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References

[1] U.S. Pharmacopeia. Ursodiol monograph.
[2] European Pharmacopoeia. Ursodiol monograph.
[3] Johnson Matthey Corporate Website. Active Pharmaceutical Ingredients.
[4] Zhejiang NHU Co., Ltd. Official Website.
[5] Dalian Meilun Biotech Co., Ltd. Product Catalog.