Ursodeoxycholic Acid capsule bulk supplier for pharma manufacturers

Ursodeoxycholic Acid Capsule 150 mg, 300 mg Suppliers & Bulk Manufacturers

Available Forms: Capsules

Available Strengths: 150 mg, 300 mg

Reference Brands: Actigall(US), rsofalk, Ursocaps, Ursode(EU)

Ursodeoxycholic acid (UDCA) is a natural bile acid that reduces cholesterol absorption and dissolves cholesterol gallstones. It improves liver function, supports bile flow, and decreases liver enzyme levels. Benefits include gallstone dissolution, liver protection, improved biliary flow, and reduced risk of liver-related complications in various hepatobiliary disorders.

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Product Description: Ursodeoxycholic acid capsules, marketed as Actigall and Ursocaps, are approved in the US by the FDA and in the EU via EMA for gallstone dissolution and liver disease. Approval requires a comprehensive dossier including clinical efficacy, safety profiles, manufacturing standards, and pharmacovigilance plans. The FDA reviews detailed clinical trial and quality data for timely approval, while the EMA ensures compliance with regional safety and manufacturing standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper regional adherence supports swift approval, safe use, and global availability, promoting gallstone management and liver health worldwide.

Ursodeoxycholic Acid Capsule — third party manufacturing & bulk supply

Ursodeoxycholic Acid Capsule 150 mg, 300 mg 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

Ursodeoxycholic Acid Capsule is supplied as Capsules — an oral solid dosage form, so the indicative MOQ is 200,000 units. 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 Ursodeoxycholic Acid Capsule 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

Ursodeoxycholic Acid capsule is listed as Capsules in 150 mg, 300 mg. Further strengths and pack presentations are confirmed with the manufacturer at RFQ stage.

Ursodeoxycholic Acid capsule is referenced against Actigall(US), rsofalk, Ursocaps, Ursode(EU). Reference brands are shown for identification only and remain the property of their respective trademark owners.