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)
Category: Gastrointestinal Drugs
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.
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:
What to include when you enquire
- Destination market — determines which manufacturers hold the right site-level approvals
- First order quantity and estimated annual volume
- Whether you need a registration dossier or the product is already registered
- Packaging, labelling and language requirements
- Incoterms and required 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. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.
Request a quote for Ursodeoxycholic Acid Capsule →The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Frequently Asked Questions
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