The Global Ursodeoxycholic Acid (UDCA) API Market was valued at USD 445.7 Million in 2022 and is projected to reach USD 942.6 Million by 2029, growing at a Compound Annual Growth Rate (CAGR) of 11.3% during the forecast period (2023-2029). This robust growth is fueled by rising global prevalence of liver disorders, increasing adoption of UDCA for gallstone dissolution therapy, and expanding applications in treating primary biliary cholangitis (PBC).

As pharmaceutical manufacturers seek high-quality API suppliers, we profile the Top 10 Companies in the Ursodeoxycholic Acid API Industry—a mix of European quality leaders, Asian production powerhouses, and specialized bile acid innovators setting global standards.

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🔟 10. Mitsubishi Tanabe Pharma

Headquarters: Osaka, Japan
Key Offering: High-purity UDCA for specialty formulations

Mitsubishi Tanabe Pharma brings decades of hepatology expertise to UDCA production, supplying API for both branded and generic medications worldwide with stringent quality control systems.

Technical Advantages:

• GMP-compliant crystallization processes
• Dedicated hepatology API production lines
• Strict impurity profile controls

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9️⃣ 9. Grindeks

Headquarters: Riga, Latvia
Key Offering: European Pharmacopoeia grade UDCA

Grindeks operates one of Northern Europe’s most advanced bile acid production facilities, supplying pharmaceutical companies with API meeting EP monograph requirements.

Technical Advantages:

• ISO 13485 certified manufacturing
• Multi-stage purification technology
• Stable supply chain for European markets

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8️⃣ 8. Arcelor Chemicals

Headquarters: Mumbai, India
Key Offering: Cost-competitive synthetic UDCA

Arcelor Chemicals has emerged as a key Asian supplier, producing UDPA through patented synthesis methods that reduce reliance on animal-derived raw materials.

Technical Advantages:

• Alternative synthesis pathway patents
• Large-scale production capacity
• Strategic partnerships with generic drug makers

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

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7️⃣ 7. Suzhou Tianlu Bio-Pharmaceutical

Headquarters: Suzhou, China
Key Offering: Dual-source UDCA production

Suzhou Tianlu specializes in bile acid APIs, offering clients flexibility through both extraction and synthesis production methods to ensure supply chain resilience.

Technical Advantages:

• Vertical integration from raw materials
• Patented purification technologies
• FDA-inspected facility

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6️⃣ 6. Biotavia Labs

Headquarters: Hyderabad, India
Key Offering: Super-refined UDCA for injectables

Biotavia focuses on high-purity UDCA meeting stringent requirements for parenteral formulations, serving innovators developing next-generation liver therapies.

Technical Advantages:

• Nanofiltration purification systems
• Endotoxin control protocols
• Sterile manufacturing capabilities

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5️⃣ 5. Abil Chempharma

Headquarters: Mumbai, India
Key Offering: Affordable UDCA for emerging markets

Abil Chempharma optimizes production economics without compromising quality, making UDCA therapy accessible in price-sensitive regions through efficient processes.

Technical Advantages:

• Continuous process improvements
• Cost-efficient crystallization methods
• Strategic raw material sourcing

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4️⃣ 4. Erregierre

Headquarters: Bergamo, Italy
Key Offering: European-manufactured UDCA

Erregierre combines traditional Italian pharmaceutical expertise with modern technology to produce UDCA API meeting the most stringent European quality standards.

Technical Advantages:

• EDQM Certificate of Suitability
• Sustainable manufacturing practices
• Documented supply chain transparency

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

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3️⃣ 3. Zhongshan Belling

Headquarters: Zhongshan, China
Key Offering: Large-scale UDCA production

Zhongshan Belling operates one of Asia’s largest UDCA manufacturing facilities, with vertically integrated capabilities from bile acid sourcing to finished API.

Technical Advantages:

• Annual capacity exceeding 300 MT
• Patented crystallization technologies
• Dual quality standards for global markets

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2️⃣ 2. Dipharma Francis

Headquarters: Milan, Italy
Key Offering: Specialty bile acid APIs

Dipharma Francis stands at the forefront of bile acid chemistry, developing advanced UDCA forms including customized particle size distributions and polymorphs.

Technical Advantages:

• Polymorph screening expertise
• QbD-based formulation support
• GMP+ manufacturing standards

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1️⃣ 1. ICE (Industria Chimica Emiliana)

Headquarters: Reggio Emilia, Italy
Key Offering: Gold standard UDCA API

ICE sets the global benchmark in Ursodeoxycholic Acid quality, supplying pharmacopoeial reference standards and premium API to innovator pharmaceutical companies worldwide.

Technical Advantages:

• Proprietary purification processes
• Chiral purity assurance systems
• Global regulatory support services

📈 Market Outlook: Expanding Therapeutic Applications Drive Growth

The UDCA API market is undergoing dynamic changes as research uncovers new therapeutic applications beyond traditional hepatology indications, while manufacturers innovate production technologies.

Key Market Trends:

• Increasing shift from animal-derived to synthetic UDCA sources
• Stricter regulatory requirements for impurity profiles
• Growing demand for specialized UDCA forms in novel drug delivery systems
• Pharmaceutical companies diversifying API sourcing for supply chain resilience

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

The companies profiled represent the innovation leaders ensuring reliable supply of this critical therapeutic agent while advancing manufacturing science in hepatology treatments.

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