Ursodiol bulk supplier for pharma manufacturers

Ursodiol Suppliers & Bulk Manufacturers

Available Forms: Tablets / Capsule / Oral suspension

Available Strengths: 200mg, 300mg, 400mg, 250mg, 500mg, 150 mg/5 mL 300 mg/5 mL

Reference Brands: Actigall (USA), Urso (EU/UK), Ursofalk (EU/UK)

Ursodiol, also known as ursodeoxycholic acid (UDCA), is a naturally occurring bile acid that is used therapeutically to treat various liver and gallbladder conditions. It is synthetically derived and functions by reducing the cholesterol content in bile, thereby promoting the dissolution of cholesterol gallstones and improving bile flow.

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Product Description:

Ursodeoxycholic acid (UDCA), also known as ursodiol, is a bile acid medication used in the management and treatment of various cholestatic liver diseases. It is commonly prescribed for conditions such as primary biliary cholangitis, gallstone dissolution in selected patients, and other disorders associated with impaired bile flow. Ursodeoxycholic acid works by reducing the production and absorption of cholesterol and by improving bile flow from the liver, which helps protect liver cells from damage caused by toxic bile acids. Its hepatoprotective properties make it an important therapeutic option in chronic liver conditions.

UDCA also helps stabilize liver function and can slow the progression of certain liver diseases when used as part of long-term management. The medication has anti-inflammatory and cytoprotective effects within the liver, contributing to improved bile secretion and reduced liver enzyme levels in many patients. It is generally administered orally and is well tolerated, with a favorable safety profile when used under medical supervision.

In clinical practice, ursodeoxycholic acid plays a significant role in managing cholestatic disorders and improving patient outcomes. Its mechanism of action, combined with its ability to enhance bile flow and reduce liver injury, makes it a valuable treatment option in hepatology and liver disease management.

Ursodiol — third party manufacturing & bulk supply

Ursodiol is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.

Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.

Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Ursodiol is supplied as Tablets / Capsule / Oral suspension — supplied in more than one dosage form, each with its own manufacturing economics, so the indicative MOQ is a minimum order value of USD 5,000 per product. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Ursodiol listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

Ursodiol is used to dissolve certain types of gallstones, treat primary biliary cholangitis (PBC), and manage liver diseases by reducing cholesterol absorption and improving bile flow.

Ursodiol is a naturally occurring bile acid or its synthetic form, designed to reduce cholesterol in bile and protect liver cells from damage.

Common trade names include Actigall (USA), Ursofalk (EU, UK), and Urso (India, LATAM).

The original brands Actigall and Ursofalk were developed by Actelion Pharmaceuticals. Many pharmaceutical companies manufacture generic ursodiol globally.

The generic name is ursodeoxycholic acid.

Main brand names: Actigall, Ursofalk, Urso.

Ursodiol is manufactured in multiple countries including the United States, European countries, India, and LATAM regions under approved pharmaceutical manufacturing standards.