The global Ursodiol market was valued at USD 258.4 Million in 2022 and is projected to reach USD 447.6 Million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 7.1% during the forecast period (2023–2030). This growth is being driven by the rising prevalence of liver diseases such as primary biliary cholangitis, increasing demand for non-surgical gallstone dissolution therapies, and the growing adoption of Ursodiol in pharmaceutical and health product applications across global healthcare sectors.

As the pharmaceutical industry evolves toward more effective and accessible treatments for hepatobiliary disorders, the focus turns to the key manufacturers who are pioneering innovations in bile acid therapies, ensuring high-quality active pharmaceutical ingredients (APIs), and expanding production capabilities. In this blog, we profile the Top 10 Companies in the Ursodiol Market—a blend of established pharmaceutical giants, specialized API producers, and innovative biotech firms shaping the future of Ursodiol supply and therapeutic advancements.

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🔟 1. Suzhou Tianlu Bio-pharmaceutical Co., Ltd.

Headquarters: Suzhou, China
Key Offering: Synthetic Ursodiol API, high-purity ursodeoxycholic acid for pharmaceutical formulations

Suzhou Tianlu Bio-pharmaceutical is a prominent player in the global Ursodiol market, specializing in synthetic ursodeoxycholic acid (UDCA) for treatments of cholestatic liver diseases and gallstone dissolution. The company leverages advanced chemical synthesis to deliver high-quality APIs meeting international standards, serving major pharma firms worldwide while expanding capacity for Asia-Pacific demand driven by lifestyle changes.

R&D Initiatives:

• Ongoing development of improved synthetic routes for higher yield and purity
• Collaborations with research institutions to explore Ursodiol’s potential in metabolic disorders
• Investment in sustainable manufacturing practices to minimize environmental impact

Download FREE Sample Report: Ursodiol Market – View in Detailed Research Report

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9️⃣ 2. Biotavia Labs Pvt. Ltd.

Headquarters: Mumbai, India
Key Offering: Extraction and synthetic Ursodiol, custom API synthesis for health products

Biotavia Labs stands out in the Ursodiol sector by offering extraction-derived and synthetic UDCA for pharmacy and nutraceutical uses, benefiting from India’s generic drug ecosystem to provide affordable liver support therapies addressing primary sclerosing cholangitis and bile flow promotion.

R&D Initiatives:

• Exploration of bio-engineered extraction techniques for natural Ursodiol variants
• Clinical studies supporting expanded indications for Ursodiol in pediatric liver conditions
• Partnerships with global pharma firms for co-development of novel delivery systems

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8️⃣ 3. Abil Chempharma Ltd.

Headquarters: Hyderabad, India
Key Offering: High-grade synthetic Ursodiol, APIs for gallstone therapy and liver protection

Abil Chempharma has carved a niche through fine chemical manufacturing of synthetic UDCA meeting international standards, supplying APIs for gallstone and chronic liver disease treatments with advanced purification to ensure low impurities.

R&D Initiatives:

• Development of chiral synthesis methods to enhance Ursodiol stereopurity
• Trials for Ursodiol combinations with other hepatoprotective agents
• Enhancing bioavailability through micronization and formulation research

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7️⃣ 4. Erregierre S.p.A.

Headquarters: Arona, Italy
Key Offering: Synthetic and semi-synthetic Ursodiol, specialized APIs for European pharma

Erregierre S.p.A. is a veteran in Europe’s Ursodiol market, producing high-purity synthetic UDCA for gallstone dissolution and cholestasis management, drawing on steroid chemistry expertise for consistent scalability and EMA-approved generics.

R&D Initiatives:

• Advanced hydrogenation techniques for cost-effective Ursodiol synthesis
• Collaborative projects with universities on Ursodiol’s neuroprotective potential
• Implementation of green chemistry principles in production processes

Download FREE Sample Report: Ursodiol Market – View in Detailed Research Report

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6️⃣ 5. Grindeks

Headquarters: Riga, Latvia
Key Offering: Pharmaceutical-grade Ursodiol, finished dosage forms for liver disorders

Grindeks plays a key role in the Ursodiol market by producing APIs and finished products like Ursoliv tablets for chronic hepatitis and biliary cirrhosis, offering integrated control and operations in over 50 countries.

R&D Initiatives:

• Bioequivalence studies to support generic Ursodiol entries in new markets
• Research into Ursodiol’s role in cystic fibrosis-related liver disease
• Sustainable sourcing of precursors to align with EU environmental directives

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5️⃣ 6. Dipharma Francis S.r.l.

Headquarters: Baranzate, Italy
Key Offering: Custom synthesis of Ursodiol API, high-volume production for global supply

Dipharma Francis excels in custom Ursodiol manufacturing for gallstone therapy and cholestasis, providing synthetic UDCA with advanced reactor capabilities and flexible scales for pharma partners across regions.

R&D Initiatives:

• Innovation in catalytic processes to improve Ursodiol yield and reduce waste
• Exploratory work on Ursodiol derivatives for enhanced therapeutic profiles
• Compliance enhancements for ANDA filings in the US market

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4️⃣ 7. Zhongshan Belling Biotechnology Co., Ltd.

Headquarters: Zhongshan, China
Key Offering: Extraction-based and synthetic Ursodiol, APIs for pharmacy and health supplements

Zhongshan Belling Biotechnology contributes to Ursodiol supply with natural extraction alternatives and chemical synthesis of UDCA, catering to traditional and modern markets while supporting high-volume output in Guangdong.

R&D Initiatives:

• Optimization of microbial fermentation for sustainable Ursodiol extraction
• Clinical collaborations to validate Ursodiol in NAFLD treatment protocols
• Expansion of cGMP-certified lines for US and EU exports

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3️⃣ 8. PharmaZell GmbH

Headquarters: Frankfurt, Germany
Key Offering: Premium synthetic Ursodiol API, contract development and manufacturing services

PharmaZell GmbH exemplifies German precision in synthetic Ursodiol for primary biliary cholangitis and gallstones, offering CDMO services from development to scale-up in Europe’s regulated environment.

R&D Initiatives:

• Advanced asymmetric synthesis for enantiomerically pure Ursodiol
• Studies on Ursodiol’s synergy with antifibrotic agents in liver fibrosis
• Digital twin technology for predictive manufacturing optimization

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2️⃣ 9. Daewoong Pharmaceutical Co., Ltd.

Headquarters: Seoul, South Korea
Key Offering: Branded Ursodiol formulations, APIs for hepatobiliary therapies

Daewoong Pharmaceutical powers Asia’s Ursodiol market with products like Udiliv for gallstones and cirrhosis protection, leveraging vertical integration and global expansion through subsidiaries.

R&D Initiatives:

• Development of enteric-coated Ursodiol for improved gastrointestinal tolerance
• Investigations into Ursodiol’s applications in viral hepatitis adjunct therapy
• International trials for new indications in pediatric populations

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1️⃣ 10. Mitsubishi Tanabe Pharma Corporation

Headquarters: Osaka, Japan
Key Offering: Branded Ursodiol (Urso), comprehensive liver disease treatment portfolio

Mitsubishi Tanabe Pharma leads with Urso for primary biliary cholangitis and gallstone management, backed by clinical data and global networks spanning Japan, the US, and Europe.

R&D Initiatives:

• Long-term studies on Ursodiol’s impact on liver transplant avoidance
• Exploration of Ursodiol in autoimmune liver diseases beyond PBC
• Strategic alliances for next-generation bile acid modulators

Get Full Report Here: Ursodiol Market – View in Detailed Research Report

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🌍 Outlook: The Future of Ursodiol Market Is Innovative and Patient-Centric

The Ursodiol market is experiencing transformative changes, with synthetic production methods coexisting alongside extraction technologies and novel formulations, as stakeholders invest in R&D for expanded indications, bioavailability, and sustainable sourcing amid regulatory and supply challenges.

📈 Key Trends Shaping the Market:

• Shift toward synthetic Ursodiol dominance due to scalability and ethical advantages over extraction methods
• Regulatory incentives for orphan drug status in rare liver diseases boosting R&D investments
• Growing use of digital tools for personalized Ursodiol dosing and adherence tracking
• Strategic mergers and acquisitions among API producers to consolidate global supply

Get Full Report Here: Ursodiol Market – View in Detailed Research Report

The companies profiled here are not only supplying essential Ursodiol—they’re pioneering the next era of hepatobiliary care, making effective treatments more accessible and innovative for patients worldwide.