Obeticholic Acid 5 mg, 10 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 5 mg, 10 mg

Reference Brands: Ocaliva (USA)

Category: Gastrointestinal Drugs

Obeticholic acid 5 mg and 10 mg tablets, a farnesoid X receptor agonist used in primary biliary cholangitis. For hospital pharmacies, specialist importers and named-patient suppliers who can check its changing approval status.

Product Description:

Obeticholic acid is a semi-synthetic bile acid, chemically 6-alpha-ethyl-chenodeoxycholic acid. It activates the farnesoid X receptor, a nuclear receptor in liver and gut that controls bile acid production and transport. Switching it on cuts bile acid synthesis and speeds export, easing the toxic build-up seen in cholestatic liver disease. This page covers 5 mg and 10 mg film-coated tablets: treatment starts at 5 mg and rises to 10 mg only if tolerated and liver tests have not improved enough.

It was approved for primary biliary cholangitis in adults, with ursodeoxycholic acid when response to that drug is inadequate, or alone when it is not tolerated. Its standing has changed. European regulators moved to withdraw its conditional authorisation after the confirmatory study did not show clear clinical benefit, and US labelling carries a boxed warning on liver decompensation and restricts use in advanced cirrhosis. Itching is the commonest adverse effect. Liver tests are monitored, bile acid sequestrants are taken four hours apart, and warfarin users need INR checks.

Sourcing notes. Because the authorisation picture has shifted, confirm current status with your regulator before committing to any order; in many markets supply may only be possible through named-patient or special-access routes. Ask for a CTD dossier, a batch CoA, the GMP certificate and a CoPP stating the registration status in the exporting country. The tablets are kept at room temperature, with no cold chain. It is prescription-only. In your enquiry, give strength, quantity, the intended access route and the remaining shelf life you require.