Ursodeoxycholic Acid Capsule 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.
Ursodeoxycholic Acid capsule is available in Capsules
and strengths such as 150 mg, 300 mg.
Sourced from GMP-certified and ISO-compliant manufacturers, this API meets
global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical
formulation and commercial manufacturing, Ursodeoxycholic Acid capsule is supplied in
bulk quantities with complete regulatory support including DMF, COA, and MSDS.
|
Technical Specifications & Supply Details
|
| Lead Time |
7 to 60 days (depending on batch size & schedule) |
| MOQ |
As per manufacturer’s batch size |
| COA |
Available with every batch |
| Regulatory Dossier / DMF |
Available upon request |
| Export Documentation |
FSC, COA, Manufacturing License, Product Permission |
| Standards |
IP, BP, USP |
| Certifications |
WHO-GMP, EU-GMP, USFDA (as applicable) |
Ursodeoxycholic Acid capsule can be exported to over 30 countries across Asia, Africa, Europe,
and Latin America. Flexible packaging, competitive pricing, and a verified supplier
network make Pharmatradz a trusted sourcing partner for pharmaceutical companies
and contract manufacturers worldwide.
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.
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