Ursodeoxycholic Acid Tablets

1. Product Introduction

Ursodeoxycholic acid (UDCA), also known as ursodiol, is a hydrophilic bile acid used for selected hepatobiliary disorders. It is an established first-line pharmacological treatment for primary biliary cholangitis (PBC), and may dissolve selected non-calcified cholesterol gallstones in patients meeting appropriate criteria.

Healthy Life Pharma Pvt. Ltd. is identified as manufacturer and Healthy Inc as exporter in the supplied commercial brief. Facility certifications, actual product registrations and manufacturing capability must be confirmed with current records.

2. Product Specifications

3. Manufacturing Technology

UDCA has limited aqueous solubility. Formulation development may assess API particle-size distribution, excipient compatibility, blend uniformity, compression properties and dissolution performance. Micronization, granulation, film coating and other technologies are potential approaches, but should not be represented as the actual manufacturing process without batch and validation evidence.

Any claimed high-dose 600 mg presentation requires separate development, approved specifications and stability assessment.

4. Quality Assurance

• Identity, assay and related-substances testing according to the approved specification.
• Dosage-unit uniformity, disintegration/dissolution and physical tablet quality where applicable.
• Stability, packaging compatibility and microbiological quality as required.
• Batch release based on validated methods and approved limits.

Fixed numerical assay or dissolution limits should not be published unless they match the specific applicable monograph and product registration.

5. Why Use Ursodeoxycholic Acid?

UDCA alters the composition of the bile acid pool and reduces the cholesterol saturation of bile. In PBC it can improve biochemical markers and clinical outcomes. For selected cholesterol gallstones, it may gradually promote dissolution, although response is variable and recurrence can occur.

• Primary biliary cholangitis: Established first-line therapy under specialist monitoring.
• Selected cholesterol gallstones: Considered only for suitable non-calcified stones and a functioning gallbladder when appropriate.
• Gallstone prevention during rapid weight loss: May be used in selected settings according to local approvals and clinician judgment.

Not a standard treatment for fatty liver disease (MASLD/NAFLD) solely to improve liver outcomes. It does not dissolve all types of gallstones and is not a substitute for urgent management of biliary obstruction or infection.

6. Export and Regulatory Support

Potential B2B registration support may include country-specific technical dossiers, certificates of analysis, product specifications and approved packaging details, subject to availability.

Claims concerning WHO-GMP, COPP, FSC, Star Export House status, shipping terms and approved markets should be checked against valid current documents. Product supply remains subject to destination-country registration and import requirements.

7. Frequently Asked Questions

Q: Is UDCA the same as ursodiol?
A: Yes, ursodiol is another name for ursodeoxycholic acid.

Q: Does UDCA dissolve every gallstone?
A: No. It may work for selected cholesterol stones; calcified or pigment stones generally do not respond.

Q: How long can gallstone treatment take?
A: Months of treatment may be needed, and success is not guaranteed. Imaging and clinical monitoring guide continuation.

Q: Are 150 mg, 300 mg and 600 mg approved in every market?
A: Not necessarily. Availability depends on the specific registered product and market.

8. Dosage and Administration

Dosage is individualized by indication, body weight, formulation and local approved label. Common specialist-guided regimens for PBC are approximately 13–15 mg/kg/day; gallstone regimens vary by jurisdiction and product. These figures are informational, not patient-specific prescriptions.

Take tablets as directed on the approved label; food instructions may vary by product. Do not alter dose, split tablets or stop long-term treatment without clinician advice.

9. Side Effects and Precautions

• Common effects: Diarrhea or loose stools, abdominal discomfort, nausea and sometimes rash or itching.
• Monitoring: Liver biochemical tests and response assessment are important, particularly in PBC; the monitoring schedule is individualized.
• Unsuitable situations: Complete biliary obstruction, certain acute gallbladder/bile duct disorders and unsuitable stone types require specialist assessment.
• Interactions: Cholestyramine, colestipol and aluminum-containing antacids may reduce absorption; clinicians may advise separating administration.
• Pregnancy, breastfeeding and pediatric use: Seek individualized professional advice and follow approved labeling.

Seek urgent care for severe abdominal pain, fever, jaundice or symptoms suggesting biliary infection/obstruction.

10. Storage Instructions

Store according to the approved market-specific label, in the original protective packaging and away from excessive heat and moisture. Do not assume a universal below-25°C condition or 36-month shelf life without approved stability data. Keep out of reach of children.