Description

Ursodeoxycholic Acid Tablets (150mg / 300mg / 600mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)

Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a specialized Manufacturer of Ursodeoxycholic Acid (UDCA) Tablets in India. Also known as Ursodiol, UDCA is a naturally occurring hydrophilic bile acid. It is the “Gold Standard” therapy for Dissolving Cholesterol Gallstones (without surgery) and treating chronic liver diseases like Primary Biliary Cholangitis (PBC).

We offer Contract Manufacturing (Third Party) services for this high-value hepatoprotective drug. UDCA is poorly soluble in water, making bioavailability a challenge. Our WHO-GMP certified facility in Mumbai utilizes Micronization and surfactant technology to ensure the drug dissolves effectively in the intestines. Healthy Inc manages the export logistics, supplying gastroenterology clinics, liver specialty centers, and pharmacy chains across the Middle East, Southeast Asia, and Latin America.

2. Product Specifications

3. Manufacturing Technology

Turning a biological acid into a stable medicine.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Bioavailability Enhancement: UDCA is a Class II drug (Low Solubility). We strictly use Micronized API to increase the surface area, ensuring the drug dissolves sufficiently to be absorbed. This is critical for achieving the high biliary concentration needed to dissolve stones.

  • Taste Masking: Bile acids are intensely bitter. We use a high-quality HPMC Film Coating to mask the taste, preventing nausea and ensuring patient compliance during long-term therapy (often 6-24 months).

  • High-Dose Formulation: For the 600mg strength (often used for maintenance), we use high-density granulation to keep the tablet size manageable for swallowing.

• The Exporter: Healthy Inc

  • Liver Care Packs: We can package UDCA in combination with other liver supplements or in specific “Monthly Therapy” blister packs designed for chronic PBC management.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >80% of the drug releases within 30-45 minutes (critical for absorption).

• Assay: We confirm the potency is strictly within 90-110% of the label claim.

• Impurity Profiling: We strictly monitor for related bile acids (Chenodeoxycholic acid) to ensure purity.

5. Why Use Ursodeoxycholic Acid?

Cleaning the liver, clearing the bile.

• Mechanism:

  1. Gallstone Dissolution: It decreases the secretion of cholesterol into bile. This lowers the “Cholesterol Saturation Index,” allowing existing cholesterol stones to slowly dissolve back into the liquid bile.

  2. Hepatoprotection (PBC): In diseases like PBC, toxic bile acids build up and damage the liver. UDCA displaces these toxic acids, replacing them with itself (a non-toxic, cytoprotective bile acid), thus slowing liver damage and fibrosis.

• Key Indications:

  • Gallstones: Dissolution of small, radiolucent (non-calcified) cholesterol gallstones in patients who cannot undergo surgery.

  • PBC: First-line treatment for Primary Biliary Cholangitis.

  • Prevention: Prophylaxis of gallstone formation in obese patients undergoing rapid weight loss.

  • Fatty Liver: Sometimes used off-label for Nonalcoholic Fatty Liver Disease (NAFLD).

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Ursodeoxycholic Acid Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Is it Urso / Actigall?

  A: Urso and Actigall are brand names. We manufacture the Generic Equivalent (Ursodiol/UDCA).

• Q: Will it dissolve all gallstones?

  A: No. It only works on Cholesterol Stones (Radiolucent – invisible on X-ray). It does not work on Calcium stones (hard stones visible on X-ray).

• Q: How long does it take?

  A: Patience is key. It usually takes 6 to 24 months to completely dissolve stones. You must take it every day.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Gallstone Dissolution: 8-10 mg/kg body weight daily (usually divided into 2-3 doses).

• PBC: 13-15 mg/kg body weight daily (divided doses).

• Gallstone Prevention: 300mg twice daily.

• Administration: Take with food or milk (increases efficiency).

9. Side Effects and Precautions

• Gastrointestinal: Diarrhea / Loose stools (Very common, dose-dependent), nausea, abdominal pain.

• Skin: Itching (Pruritus), rash.

• Monitoring: Liver Function Tests (LFTs) should be monitored every month for the first 3 months, then every 6 months.

• Contraindications: Calcified gallstones, non-functioning gall bladder, acute cholecystitis (infection).

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep container tightly closed.