Ursodeoxycholic Acid

Overview

Ursodeoxycholic Acid is a naturally occurring bile acid used for the treatment of primary biliary cholangitis (PBC), dissolution of radiolucent gallstones in patients who are not suitable for gallbladder surgery, and treatment of hepatobiliary disorders associated with cystic fibrosis in pediatric patients. It plays a vital therapeutic role by improving bile flow, reducing liver enzyme levels, and gradually dissolving cholesterol-rich gallstones.

Our Ursodeoxycholic Acid API is manufactured under stringent quality standards in GMP-certified facilities, and we offer complete regulatory support including CEPs and DMFs.

Applications

Ursodeoxycholic Acid is used in multiple medical applications, including:

• Primary Biliary Cholangitis (PBC)

Cholesterol cholelithiasis / Cholestatic Liver Diseases(cholesterol stones present in the bile)

• Biliary dyspepsia (digestive problems due to altered functioning of the gallbladder)
• Cystic Fibrosis – Associated Hepatobiliary Disorders in pediatric patients
• Non-Alcoholic Steatohepatitis (NASH) (under investigation in clinical studies)
• Type 2 Diabetes (under investigation in clinical studies)

End uses and Mechanism of Action

Ursodeoxycholic Acid reduces elevated liver enzymes by enhancing bile flow and protecting liver cells from toxic bile acids. Its primary mechanism is anticholelithic.

Its main mechanism of action can be summarised as follows:

1. Cytoprotective: Replaces toxic bile acids with less harmful, hydrophilic UDCA, reducing bile-induced liver cell damage.
2. Choleretic: Stimulates bile flow by enhancing bile acid secretion and upregulating bile transporters.
3. Anti-apoptotic: Protects liver cells by stabilizing mitochondria and inhibiting cell death pathways.
4. Immunomodulatory: Reduces autoimmune activity by lowering antigen presentation and inflammatory cytokine release.
5. Detoxifying: Promotes bile acid metabolism and excretion, reducing intrahepatic bile accumulation.

Product Specifications

• CAS Number: 128-13-2
• EC Number: 99 128-13-2
• Molecular Formula: C₂₄H₄₀O₄
• Molecular Weight: 576
• Chemical Name: (3α,5β,7β)-3,7-Dihydroxycholan-24-oic acid
• Synonyms: 17-beta-(1-Methyl-3-carboxypropyl) etiocholane-3-alpha,7-beta-diol
• UNII: 0GEI24LG0J
• Form: White Crystalline Powder

Manufacturing and Quality Assurance

Our production facilities in Italy, India and Japan  adheres to stringent GMP standards, ensuring the highest level of quality and safety in every batch. Our GMP-certified Ursodeoxycholic Acid is available in secure packaging options to meet pharmaceutical industry requirements.

Regulatory Compliance

Our commitment to quality, compliance, and safety ensures that our Ursodeoxycholic Acid API meets global pharmaceutical industry standards, making it a reliable choice for pharmaceutical applications worldwide.

• GMP Compliance: Yes
• DMF Available: Yes
• Chemical CEP: Yes
• BSE/TSE CEP: Yes

Active Registrations a.o. with:

• FDA (Food and Drug Administration)
• EMA (European Medicines Agency)
• MHRA (Medicines & Healthcare Products Regulatory Agency)
• CDSCO (Central Drugs Standard Control Organization)
• Health Canada
• PMDA (Pharmaceuticals and Medical Devices Agency)
• CDE (Center for Drug Evaluation China)
• MFDS (Ministry of Food and Drug Safety of the Republic of Korea)
• EAEU Authorities

Partner with ICE Pharma

With decades of experience in API development and production, ICE Pharma is your ideal partner for Ursodeoxycholic Acid API sourcing. We prioritise quality, regulatory readiness, and responsive client service to support your pharmaceutical manufacturing and development goals.