Ursodeoxycholic Acid 300 mg Tablets: Uses, Dose & Manufacturer

Reviewed by Anil Kumar Goel, B.Pharm — Chairman, Biozia Lifesciences, 40+ years in the pharmaceutical industry.

Ursodeoxycholic acid (UDCA) is a naturally occurring bile acid used to dissolve certain gallstones and to treat chronic cholestatic liver disease. The 300 mg tablet is the most commonly prescribed strength in India. This guide covers how UDCA works, its uses and weight-based dosing, safety points, and how Biozia supplies it as Ursizia-300 Tablet.

Key takeaways (TL;DR)

UDCA is a hydrophilic bile acid that makes bile less toxic and less likely to form cholesterol stones.
Used to dissolve small, non-calcified cholesterol gallstones and to treat primary biliary cholangitis (PBC) and other cholestatic liver conditions.
Dose is weight-based: about 8–10 mg/kg/day for gallstones and 13–15 mg/kg/day for PBC, taken with food.
Generally well tolerated; loose stools are the most common side effect.
Biozia supplies Ursizia-300 (10×10 Alu/Alu) for PCD franchise and third-party manufacturing.

Composition and available strengths

Biozia manufactures ursodeoxycholic acid as:

Brand	Composition	Packing
Ursizia-300 Tablet	Ursodeoxycholic Acid 300 mg	10×10 Alu/Alu

How ursodeoxycholic acid works

UDCA reduces the amount of cholesterol the liver secretes into bile and helps dissolve cholesterol from existing stones. It also replaces more toxic bile acids in the bile pool, protects liver and bile-duct cells, and improves bile flow. That is why it is used both for gallstones and for cholestatic liver disease.

Uses

Dissolution of small, radiolucent (non-calcified) cholesterol gallstones in patients with a functioning gallbladder
Primary biliary cholangitis (PBC)
Other cholestatic liver conditions, as decided by a specialist
Prevention of gallstones during rapid weight loss, where prescribed

Dosage

UDCA dosing is calculated on body weight and set by the doctor. Commonly used ranges are about 8–10 mg/kg/day for gallstone dissolution and 13–15 mg/kg/day for PBC, divided through the day and taken with meals. Gallstone dissolution can take 6 months to 2 years, with periodic ultrasound checks.

Side effects

The most common side effect is soft stools or diarrhoea. Others include abdominal discomfort, nausea and, rarely, itching or rash. Liver function tests are usually monitored during long-term treatment.

Precautions and contraindications

Not for acute inflammation of the gallbladder or bile ducts, or blocked bile ducts.
Not suitable for calcified or pigment stones, or a non-functioning gallbladder.
Bile-acid binders (cholestyramine) and aluminium antacids reduce absorption; separate doses by a few hours.
Use in pregnancy only if clearly needed and advised by a doctor.

For distributors: PCD franchise and third-party manufacturing

UDCA is a long-duration, repeat-prescription molecule used by gastroenterologists, hepatologists and physicians, so each patient generates months of steady demand. Ursizia-300 fits a gastro-hepatic range for franchise partners and is also available as an own-brand product through third-party manufacturing.

PCD franchise — stock Ursizia-300 under monopoly rights in your district. See PCD pharma franchise with Biozia.
Third-party manufacturing — get this formulation made under your own brand name. See third-party manufacturing services.
Quality — WHO-GMP and ISO certified manufacturing in Yamunanagar, Haryana, with batch-wise documentation and pan-India dispatch.

Interested in ursodeoxycholic acid 300 mg tablets for your territory or your own brand? Enquire with Biozia Lifesciences →

Frequently asked questions

What is ursodeoxycholic acid 300 mg used for?

It is used to dissolve certain cholesterol gallstones and to treat cholestatic liver diseases such as primary biliary cholangitis.

How much ursodeoxycholic acid should be taken per day?

The dose is weight-based and set by the doctor — typically about 8–10 mg/kg/day for gallstones and 13–15 mg/kg/day for PBC, taken with food.

How long does UDCA take to dissolve gallstones?

Usually 6 months to 2 years, and it works only for small, non-calcified cholesterol stones in a functioning gallbladder.

Is ursodeoxycholic acid available for PCD franchise?

Yes. Biozia offers Ursizia-300 for PCD franchise and can manufacture UDCA tablets under your own brand.

This guide is for pharmacists, doctors, distributors and trade partners. It is general product information, not medical advice — patients should take any medicine only as prescribed by a registered medical practitioner.