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 (ursodeoxycholic acid) tablets, capsules and oral suspension, a bile acid medicine for cholestatic liver disease and gallstones. For importers, distributors, hepatology units and hospital tender buyers.

Get Enquiry / Request Bulk Quote

Usually answered within 48 hours | GMP documents shared before you commit

Manufacture or export Ursodiol? List it or send an offer →

Product Description:

Ursodiol, also called ursodeoxycholic acid, is a hydrophilic bile acid present in small amounts in human bile. It lowers the cholesterol saturation of bile and displaces more toxic bile acids, protecting liver cells and improving bile flow. This page brings together several oral forms: tablets and capsules from 200 mg to 500 mg, and oral suspensions at the strengths listed here. The suspension allows dosing by weight in children and helps people who cannot swallow tablets.

Ursodiol is a first-line therapy in primary biliary cholangitis, where it is taken every day for life at a dose based on body weight. It is also used to dissolve small radiolucent cholesterol gallstones in a functioning gallbladder. Some labels add gallstone prevention during rapid weight loss. Doses are taken with food. Bile acid sequestrants and aluminium antacids bind the drug, so they are taken apart, and ciclosporin levels can change.

Sourcing notes. Ursodiol is prescription-only in most markets. Most UDCA API is made from animal bile acids, so ask the finished-product maker for the API source species and a TSE/BSE statement or a CEP that covers TSE risk. Request a CTD or ACTD dossier for the exact form and strength, with bioequivalence or a justified biowaiver. Tablets and capsules go in blisters at room temperature. For the suspension, check preservatives, measuring device and in-use shelf life. Ask for batch CoAs, a GMP certificate and a CoPP, and name the form, strength, quantity and destination when you enquire.

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.

Request a quote for Ursodiol →

Usually answered within 48 hours, with matched manufacturers, indicative prices and document status.

Back to Listing

Frequently Asked Questions

To dissolve cholesterol gallstones in selected patients with a working gallbladder, to prevent gallstones during rapid weight loss, and to treat primary biliary cholangitis (PBC). Approved uses vary by country.

Yes. Ursodiol is the US name for ursodeoxycholic acid (UDCA).

Actigall and Urso in the US, Ursofalk (Dr. Falk Pharma) in Europe and Udiliv in India, among many generics.

UDCA API is made by manufacturers in several countries, including India, China and Europe. We match each enquiry with manufacturers whose source material, documents and approvals fit your market.

Often, yes: most UDCA is made from bile acids obtained from cattle bile. A few makers offer non-animal material made from plant sterols. Ask your supplier which route it uses and for the matching TSE/BSE documents.