The Global Ursodeoxycholic Acid API Market was valued at US$ 445.7 million in 2022 and is projected to reach US$ 942.6 million by 2029, growing at a Compound Annual Growth Rate (CAGR) of 11.3% during the forecast period (2023-2029). This growth is driven by increasing prevalence of liver diseases, rising demand for gallstone treatments, and expanding applications in primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC) therapies.

Ursodeoxycholic Acid is also known as ursodiol (USAN). Ursodeoxycholic acid (3,7-2-hydroxy-5-bile acid, UDCA) was first found in the bile of a black bear. As the pharmaceutical industry continues to innovate hepatology treatments, the spotlight is on the key API manufacturers who are driving quality, purity, and production efficiency. In this blog, we profile the Top 10 Companies in the Ursodeoxycholic Acid API Industry—a mix of established pharmaceutical giants and specialized biochemical producers shaping the future of liver therapeutics.

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🔟 1. ICE (Industria Chimica Emiliana)

Headquarters: Reggio Emilia, Italy
Key Offering: High-purity UDCA APIs for pharmaceutical applications

ICE is a global leader in bile acid derivatives and Ursodeoxycholic Acid API production, with over 60 years of experience in steroid chemistry. The company operates state-of-the-art manufacturing facilities in Italy that comply with cGMP, USFDA, EDQM, PMDA, and KFDA standards.

Quality Initiatives:

• Vertical integration from raw materials to finished APIs
• Purity levels exceeding 99.5% for pharmaceutical-grade UDCA
• Continuous process optimization for enhanced yield and sustainability

Download FREE Sample Report: Ursodeoxycholic Acid API Market – View in Detailed Research Report

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9️⃣ 2. Grindeks

Headquarters: Riga, Latvia
Key Offering: Pharmaceutical-grade UDCA APIs and finished dosage forms

Grindeks is a vertically integrated pharmaceutical company with strong capabilities in Ursodeoxycholic Acid production. The company supplies APIs to over 70 countries and manufactures finished products under brands like Ursosan® and Ursofalk®.

Quality Initiatives:

• Dual sourcing of raw materials for supply chain security
• Ongoing formulation development for improved bioavailability
• Strict compliance with EU GMP and PIC/S standards

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8️⃣ 3. Mitsubishi Tanabe Pharma

Headquarters: Osaka, Japan
Key Offering: Ultra-pure UDCA for Japanese and international markets

Mitsubishi Tanabe Pharma is a key player in the Asian Ursodeoxycholic Acid API market, with specialized production facilities meeting Japan’s stringent pharmaceutical standards. The company has been expanding its export capabilities to serve global pharmaceutical customers.

Quality Initiatives:

• Patented purification technologies for impurity control
• Stable isotope-labeled UDCA for research applications
• Tailored particle size distributions for formulation optimization

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7️⃣ 4. Daewoong Chemical

Headquarters: Seoul, South Korea
Key Offering: Cost-competitive UDCA for generic drug manufacturers

Daewoong Chemical has emerged as a leading Ursodeoxycholic Acid API supplier in Asia, leveraging Korea’s strong position in fine chemical manufacturing. The company provides high-quality UDCA at competitive prices while maintaining strict quality standards.

Quality Initiatives:

• Continuous process improvements for yield enhancement
• Advanced analytical methods for quality control
• Strategic partnerships with global pharmaceutical companies

Download FREE Sample Report: Ursodeoxycholic Acid API Market – View in Detailed Research Report

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6️⃣ 5. PharmaZell GmbH

Headquarters: Raubling, Germany
Key Offering: Highly purified Ursodeoxycholic Acid for European and US markets

PharmaZell is a globally recognized API manufacturer with specialized expertise in steroid and bile acid chemistry. The company’s UDCA products meet the most stringent pharmacopeial requirements for pharmaceutical applications.

Quality Initiatives:

• Modern multi-purpose production plants with flexible capacity
• Strict environmental controls for sustainable production
• Comprehensive regulatory support for market authorization

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5️⃣ 6. Dipharma Francis

Headquarters: Milan, Italy
Key Offering: High-purity UDCA APIs and intermediates

Dipharma Francis has been a reliable supplier of Ursodeoxycholic Acid for decades, with production facilities in Italy that serve global pharmaceutical companies. The company offers both synthetic and extraction-based UDCA products.

Quality Initiatives:

• Advanced crystallization techniques for purity optimization
• GMP-compliant manufacturing processes
• Custom synthesis capabilities for specialized UDCA derivatives

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4️⃣ 7. Zhongshan Belling

Headquarters: Zhongshan, China
Key Offering: Competitive UDCA APIs for domestic and export markets

Zhongshan Belling is one of China’s leading Ursodeoxycholic Acid producers with rapidly expanding international market presence. The company has been investing heavily in production technology upgrades to meet increasing quality demands.

Quality Initiatives:

• Implementation of ICH Q7 compliant quality systems
• Vertical integration with bile acid raw material sources
• Growing portfolio of regulatory filings for international markets

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3️⃣ 8. Erregierre

Headquarters: Bergamo, Italy
Key Offering: European-sourced UDCA with full traceability

Erregierre specializes in niche APIs including high-quality Ursodeoxycholic Acid. The company serves both originator and generic drug manufacturers with products that meet European Pharmacopoeia specifications.

Quality Initiatives:

• Complete supply chain transparency
• Small-batch production for specialized customer needs
• Strong focus on environmental sustainability in production

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2️⃣ 9. Abil Chempharma

Headquarters: Hyderabad, India
Key Offering: Cost-effective UDCA for emerging markets

Abil Chempharma has established itself as a reliable Indian manufacturer of Ursodeoxycholic Acid API. The company supplies to domestic formulation manufacturers as well as generic drug companies in regulated markets.

Quality Initiatives:

• USFDA and EU GMP compliant manufacturing
• Efficient synthetic routes for competitive pricing
• Growing clinical trial material capabilities

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1️⃣ 10. Biotavia Labs

Headquarters: Saint Petersburg, Russia
Key Offering: UDCA for CIS and adjacent markets

Biotavia Labs is a key supplier of Ursodeoxycholic Acid in Eastern Europe and Central Asia. The company combines local raw material sourcing with modern production technologies to serve regional pharmaceutical needs.

Quality Initiatives:

• Local regulatory expertise for Eurasian markets
• Custom particle engineering services
• Ongoing analytical method development

Get Full Report Here: Ursodeoxycholic Acid API Market – View in Detailed Research Report

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🧪 Outlook: The Future of Ursodeoxycholic Acid API Is Increasingly Sophisticated

The Ursodeoxycholic Acid API market is undergoing significant changes as manufacturers respond to evolving pharmaceutical demands and regulatory requirements. While traditional gallstone treatments remain the primary application, emerging uses in liver diseases and potential new therapeutic areas are driving innovation.

📈 Key Trends Shaping the Market:

• Growing demand for higher purity grades (≥99.5%)
• Increasing regulatory scrutiny of impurity profiles
• Shift toward more sustainable production methods
• Expansion of Asian manufacturers in global markets

Get Full Report Here: Ursodeoxycholic Acid API Market – View in Detailed Research Report

The companies listed above are not only supplying essential APIs—they’re driving the advancement of hepatology treatments worldwide.