Description
Ursodeoxycholic Acid Tablets (UDCA 150 mg/300mg / 450mg / 600mg)
Manufactured by Healthy Life Pharma Pvt. Ltd. | Exported by Healthy Inc
1. Product Introduction Healthy Life Pharma Pvt. Ltd. is a premier manufacturer of Ursodeoxycholic Acid Tablets in India. Also known as Ursodiol, this medication is the gold standard for treating chronic liver diseases and dissolving gallstones. We produce high-purity film-coated tablets. Our facility adheres to strict WHO-GMP standards. Therefore, we guarantee bioavailability and efficacy. Healthy Inc manages our global exports and bulk tenders.
2. Product Specifications | Parameter | Specification | | :— | :— | | Product Name | Ursodeoxycholic Acid Tablets | | Generic Name | Ursodeoxycholic Acid (UDCA) / Ursodiol USP / BP | | Strength | 150mg / 300mg / 450mg / 600mg | | Dosage Form | Film Coated Tablet | | Standard | USP / BP / IP Compliant | | Therapeutic Class | Hepatoprotective / Cholagogue | | Shelf Life | 36 Months | | Packaging | 10×10 Blister / 10×15 Strip / Bulk Jar |
3. Manufacturing Ursodeoxycholic Acid Tablets We divide our operations to ensure specialized focus.
The Manufacturer: Healthy Life Pharma Pvt. Ltd. First, Healthy Life Pharma handles manufacturing. We operate a WHO-GMP certified plant in Mumbai. UDCA is a bile acid and has a naturally intense bitter taste. Therefore, we use advanced Film Coating Technology. This masks the taste effectively, ensuring patients can take the medication long-term without discomfort. We also strictly control the particle size of the raw material. This ensures the drug dissolves properly in the digestive tract.
The Exporter: Healthy Inc Second, Healthy Inc manages international trade. This division handles logistics for Ursodeoxycholic Acid Tablets. We supply gastroenterology clinics and distributors globally. We offer specific strengths (like 450mg or 600mg) that are popular in high-end export markets.
4. Quality Assurance We test every batch rigorously.
Assay Verification: We use HPLC testing. This confirms the purity of the UDCA.
Dissolution: We test how the tablet releases the drug. Since bile acids have low solubility, passing this test is critical for the drug to work.
Related Substances: We check for impurities to ensure the safety of the liver.
5. Why Use Ursodeoxycholic Acid Tablets? This drug protects the liver and manages bile flow.
Mechanism: It replaces toxic hydrophobic bile acids with non-toxic hydrophilic UDCA.
Effect: It protects liver cells from damage and helps dissolve cholesterol-rich gallstones.
Key Indications:
Treatment of Primary Biliary Cholangitis (PBC).
Dissolution of radiolucent Gallstones (Cholelithiasis).
Prevention of gallstones in obese patients undergoing rapid weight loss.
Management of Cystic Fibrosis-related liver disease.
6. Export and Regulatory Support We provide complete documentation for registration.
Dossier: We offer CTD and ACTD formats.
Certificates: We supply the Free Sale Certificate (FSC) and COPP.
Logistics: We ship via FOB Mumbai or CIF.
7. Frequently Asked Questions
Q: Who manufactures Ursodeoxycholic Acid Tablets? A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.
Q: Is this the same as Ursodiol? A: Yes, Ursodiol is the American name for Ursodeoxycholic Acid. It is the same drug.
Q: Are the tablets bitter? A: The drug inside is bitter, but our tablets are Film Coated to prevent any bitter taste during swallowing.
CLINICAL PHARMACOLOGY & SAFETY INFORMATION (For Registered Medical Practitioners & Patient Reference)
8. Dosage and Administration
Gallstone Dissolution: Typically 8-10 mg/kg body weight daily, divided into 2 or 3 doses.
Primary Biliary Cholangitis (PBC): Typically 13-15 mg/kg body weight daily.
Administration: Take with food or milk. This improves absorption and reduces stomach upset.
Duration: Treatment is often long-term (months or years).
9. Side Effects and Precautions
Common Side Effects: Diarrhea or soft stools are the most common effects. Nausea may also occur.
Monitoring: Liver function tests (AST/ALT) should be monitored regularly.
Contraindications: Not for patients with calcified gallstones or acute inflammation of the gallbladder.
10. Storage Instructions
Store below 25°C in a dry place.
Protect from moisture.
Keep out of reach of children.
