Bulk Pharmaceutical API Sources for URSO 250

Bulk Pharmaceutical API Sources for URSO 250

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		U5127_SIGMA
TCI (Tokyo Chemical Industry)		U0030
Molport		MolPort-001-794-630
Hangzhou APIChem Technology		AC-18919
AKos Consulting & Solutions		AKOS015955898
Mcule		MCULE-4374611501

Bulk Active Pharmaceutical Ingredient (API) Sources for URSO 250

Last updated: July 30, 2025

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Introduction

URSO 250, also known as Ursodeoxycholic Acid (UDCA), is a critical pharmaceutical compound used primarily to treat gallstone dissolution and certain liver diseases, including primary biliary cholangitis. As the demand for URSO 250 escalates globally, the importance of securing reliable, high-quality bulk API sources becomes paramount for pharmaceutical manufacturers. This article evaluates the landscape of API sourcing options, focusing on established manufacturers, emerging suppliers, and geographic considerations influencing procurement strategies.

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Understanding URSO 250 and Its API

Ursodeoxycholic Acid (UDCA) is a secondary bile acid naturally occurring in small quantities in healthy human bile. The synthetic or bio-derived API must meet stringent purity standards, typically surpassing 98%, as per pharmacopeial guidelines such as USP, EP, or BP. The manufacturing process involves complex chemical synthesis or microbial biotransformation, requiring advanced technology and quality controls.

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Key Criteria for API Suppliers

Selecting a reliable API supplier for URSO 250 involves evaluating several factors:

• Regulatory Compliance: Verification of approval status in target markets (e.g., FDA, EMA, PMDA).
• Manufacturing Capacity: Ability to meet volume demands consistent with business growth.
• Quality Assurance: Good Manufacturing Practice (GMP) adherence, stability, and purity profiles.
• Supply Chain Stability: Risk mitigation against geopolitical and logistical disruptions.
• Pricing and Lead Times: Competitive prices without compromising quality.

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Major API Manufacturers of Ursodeoxycholic Acid (URSO 250)

1. Zydus Cadila (India)

Zydus Cadila is a prominent Indian pharmaceutical company recognized for its robust API manufacturing capabilities, including UDCA. Their API facilities comply with international GMP standards, and they possess extensive R&D to optimize production processes, ensuring high-quality, cost-effective API supplies for the global market.

2. Wockhardt (India)

Wockhardt offers bulk Ursodeoxycholic Acid API, catering to both generic sectors and branded formulations. Their manufacturing units are FDA- and EUGMP-approved, offering reliable supply chains. Wockhardt’s strategic presence in India makes it a cost-efficient sourcing option with the capacity to fulfill large volume orders.

3. Changzhou API Co., Ltd. (China)

A key Chinese API manufacturer with a notable portfolio that covers UDCA. Changzhou API maintains compliance with international standards and has seen increasing quality certification accreditations—vital factors for the global pharmaceutical supply chain. China’s competitive manufacturing costs and expanding regulatory alignments make it a significant source.

4. Sichuan Chuanwei Pharmaceutical (China)

Specializing in bile acids and related pharmaceuticals, Sichuan Chuanwei offers high-quality URSO 250 API. Their focus on biosynthesis and chemical synthesis routes ensures product purity and consistent quality, supported by local regulatory approvals.

5. Hubei Hongxing Pharmaceutical (China)

This manufacturer has expanded its portfolio to include UDCA, leveraging advanced synthetic methods to produce high-purity API. Their emphasis on quality control and competitive pricing makes them suitable for companies seeking scalable API sources.

6. International API Vendors and Contract Manufacturing Organizations (CMOs)

Global players such as Evonik Industries and respectably certified CMOs offer custom synthesis and large-scale production of UDCA. Their compliance with international standards (e.g., ICH guidelines) and extensive experience provide additional reliability for multinational buyers.

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Emerging and Niche API Sources

As supply chain diversification gains importance, some smaller or newer entrants have entered the URSO API market:

• Turkish API Producers: Turkey’s pharmaceutical industry is advancing its biopharmaceutical manufacturing, with a focus on bile acids, offering alternative regional sourcing options.
• South Korean Manufacturers: Leveraging advanced synthesis techniques, some Korean firms are developing high-purity UDCA APIs with strict quality controls.
• European SMEs: Certain European biotech firms focus on biosynthetic routes, aiming for environmentally friendly, sustainable production processes.

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Geographical Trends in API Sourcing

• India and China remain dominant due to cost advantages, established infrastructure, and regulatory harmonization efforts.
• Europe and North America rely more on established multinational API providers or regional CMOs, often driven by stricter regulatory standards and supply chain security concerns.
• Emerging markets are gradually increasing their influence, with investments in technology and quality to meet global standards.

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Regulatory Considerations

Sourcing URSO 250 API requires careful attention to compliance documentation, stability data, and certificates of analysis. International manufacturers with a history of regulatory approvals and rigorous quality systems provide a competitive advantage, facilitating seamless registration and market access in different jurisdictions.

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Supply Chain and Quality Assurance

Pharmaceutical firms should prioritize API suppliers with:

• Certified GMP manufacturing facilities.
• Robust quality testing protocols.
• Proven track record of consistent batch quality.
• Transparent supply chain management to mitigate risks.

In recent years, regulatory bodies like the FDA and EMA have increased scrutiny on API suppliers, emphasizing the importance of comprehensive audits and supplier qualification programs.

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Pricing Dynamics and Contract Negotiation

API costs are influenced by:

• Raw material availability.
• Manufacturing complexity.
• Scale of order.
• Regulatory compliance costs.

Negotiating long-term supply agreements can result in favorable pricing and priority during supply shortages. Buyers should also consider total cost of quality, including potential regulatory delays from substandard API sources.

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Challenges in API Sourcing for URSO 250

• Regulatory Variances: Differing standards across markets require due diligence.
• Supply Disruptions: Geopolitical tensions or pandemic-related restrictions affect production and logistics.
• Quality Concerns: Inconsistencies in Chinese API sources have historically prompted increased audits and certifications.
• Intellectual Property Risks: Ensuring suppliers do not infringe on patents or proprietary processes.

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Conclusion

Securing a dependable bulk API source for URSO 250 necessitates a comprehensive evaluation of supplier credentials, regulatory compliance, production capacity, and quality assurance frameworks. Leading suppliers in India and China dominate the market, supported by emerging regional players offering diversification. Companies should prioritize strategic partnerships, conduct thorough supplier audits, and stay informed about evolving regulatory landscapes to mitigate risks and optimize supply chain resilience.

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Key Takeaways

• Prioritize GMP-certified suppliers: Ensure compliance with international standards to streamline registration and market approval processes.
• Diversify supply sources: Reduce dependency on a single region, especially amid geopolitical uncertainties.
• Assess supplier capacity and reliability: Match API provider capabilities with demand forecasts.
• Maintain rigorous quality controls: Protect brand reputation and ensure patient safety.
• Negotiate long-term contracts: Benefit from favorable pricing, priority supply, and stability.

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FAQs

1. What are the leading regions producing URSO 250 API?
India and China are the predominant regions, boasting extensive manufacturing capacities and cost advantages. European and North American suppliers offer high-compliance options but often at higher prices.

2. How can buyers ensure the quality of URSO 250 API?
Through detailed auditing, verifying GMP compliance, reviewing Certificates of Analysis, and conducting rigorous laboratory testing of batches before approval.

3. Are there any risks associated with sourcing from Chinese API manufacturers?
Risks include variability in quality, regulatory compliance, and supply chain disruptions. However, reputable Chinese manufacturers with international certifications mitigate these concerns.

4. What regulatory considerations should be taken into account when sourcing URSO 250 API?
Manufacturers must ensure API suppliers comply with GMP standards and possess necessary certifications for target markets, ensuring smooth registration and market entry.

5. How can pharmaceutical companies mitigate supply chain disruptions for URSO 250?
By diversifying suppliers, establishing long-term agreements, maintaining safety stock, and conducting ongoing supplier audits to ensure continuous supply and quality consistency.

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References

[1] U.S. Pharmacopeia. Ursodeoxycholic Acid Monograph.
[2] European Pharmacopoeia. Ph. Eur. 9.0. Ursodeoxycholic Acid.
[3] B. Patel et al., "Global API Market Overview," Pharmaceutical Technology, 2022.
[4] WHO, "Guidelines on Good Manufacturing Practices," 2020.
[5] S. Li et al., "Analysis of API Sourcing Strategies," Journal of Pharmaceutical Innovation, 2021.