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Obeticholic acid bulk supplier for pharma manufacturers

Obeticholic Acid 5 mg, 10 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 5 mg, 10 mg

Reference Brands: Ocaliva (USA)

Category: Critical Care

Obeticholic Acid is a Critical Care product available as Tablets in strengths 5 mg, 10 mg. It corresponds to the reference brand Ocaliva (USA). Verified GMP manufacturers and suppliers on PharmaTradz offer it in bulk for import worldwide, with regulatory documentation and dossier support available on request.

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📘 Sourcing Guide

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.

Obeticholic Acid — third party manufacturing & bulk supply

Obeticholic Acid 5 mg, 10 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.

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 Obeticholic Acid 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.

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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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