Obeticholic Acid Suppliers & Bulk Manufacturers
Available Forms: Tablets
Available Strengths: 5 mg, 10 mg
Reference Brands: Ocaliva (USA)
Category: Critical Care
Obeticholic acid is available in Tablets and strengths such as 5 mg, 10 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, Obeticholic acid 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) |
Obeticholic acid 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:
Obeticholic acid is a medication prescribed for the management of primary biliary cholangitis (PBC), a chronic liver disease characterized by progressive bile duct damage and liver dysfunction. It is a semi-synthetic bile acid analogue, chemically known as 6α-ethyl-chenodeoxycholic acid, that works by activating the farnesoid X receptor (FXR) in the liver. Activation of FXR helps regulate bile acid synthesis and transport, reduces bile acid accumulation, and supports liver function.
Sold under the brand name Ocaliva, obeticholic acid is typically used in adults who have not responded adequately to ursodeoxycholic acid (UDCA) or are unable to tolerate UDCA. The medication is available as oral tablets in strengths of 5 mg and 10 mg, allowing for flexible dosing based on patient needs.
Obeticholic acid therapy requires careful monitoring due to potential liver-related adverse effects, and dosing must be individualized according to disease severity and patient response. It is an important treatment option in critical care for patients with PBC, helping healthcare professionals provide targeted, safe, and effective management. Intercept Pharmaceuticals Inc. holds the rights to Ocaliva outside Japan and China, where it is licensed to Dainippon Sumitomo Pharma.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Frequently Asked Questions
Obeticholic acid is used to treat primary biliary cholangitis (PBC) in adults, a chronic liver disease. It is prescribed for patients who do not respond adequately to ursodeoxycholic acid (UDCA) or cannot tolerate UDCA.
Obeticholic acid is a synthetic bile acid derivative that activates the farnesoid X receptor (FXR), helping regulate bile acid synthesis and liver metabolism.
The main trade name of obeticholic acid is Ocaliva.
Obeticholic acid under the brand Ocaliva is manufactured by Intercept Pharmaceuticals, Inc.
The generic name is obeticholic acid.
The brand name is Ocaliva.
Obeticholic acid is manufactured in the United States by Intercept Pharmaceuticals under strict quality standards.
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