Ursodeoxycholic Acid BP Sugar-Coated 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

For sugar-coated UDCA tablets, formulation development considers active-ingredient quality, particle size, blend uniformity, tablet compression, sugar-coating performance and dissolution. Sugar coating can improve swallowability and mask unpleasant taste. Actual equipment, coating composition and processing parameters must be established from the approved manufacturing dossier rather than assumed.

Healthy Life Pharma Pvt. Ltd. and Healthy Inc are the manufacturer and exporter named in the supplied brief. Manufacturing site status and certifications require current verification.

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Fixed numerical assay or dissolution limits should not be published unless they match the specific applicable monograph and product registration.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 support may include CTD/ACTD documentation, certificates of analysis, product specifications and registration-related documentation, subject to actual availability and destination-market requirements.

WHO-GMP, COPP, Free Sale Certificate, Star Export House status, pack sizes, export markets and shipping terms must be confirmed against current official records before publication as verified claims.

7. Frequently Asked Questions

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

Q: Which strengths are confirmed by the supplied product labels?
A: Sugar-coated tablets containing UDCA BP 150 mg or 300 mg. The 450 mg and 600 mg strengths mentioned in the broader marketing description are not confirmed by the supplied labels.

Q: Can UDCA dissolve all gallstones?
A: No. It is used only for selected cholesterol gallstones in suitable patients and is not effective for calcified stones.

Q: Is it a film-coated tablet?
A: The supplied 150 mg and 300 mg labels explicitly specify sugar-coated tablets, so this page uses that dosage form.

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.