Obeticholic Acid Production Cost Reports

The report provides a detailed analysis essential for establishing an Obeticholic Acid production plant. It encompasses all critical aspects necessary for Obeticholic Acid production, including the cost of Obeticholic Acid production, Obeticholic Acid plant cost, Obeticholic Acid production costs, and the overall Obeticholic Acid production plant cost. Additionally, the study covers specific expenditures associated with setting up and operating an Obeticholic Acid production plant. These encompass production processes, raw material requirements, utility requirements, infrastructure needs, machinery and technology requirements, manpower requirements, packaging requirements, transportation requirements, and more.

Obeticholic acid is a farnesoid X receptor (FXR) agonist that is used to treat primary biliary cholangitis (PBC). It is utilised in adults with inadequate response to ursodeoxycholic acid (UDCA) or as monotherapy for UDCA-intolerant patients. It reduces bile production and enhances bile acid removal to slow liver damage progression.

It is also utilised in non-alcoholic steatohepatitis (NASH) fibrosis improvement through histological benefits in phase III, targeting inflammation, steatosis, and fibrosis via FXR-mediated metabolic regulation. It is employed in sclerosing cholangitis, alcoholic fatty liver disease, and bile acid diarrhoea management by modulating bile salt export and insulin sensitivity. Its common side effects include itching, fatigue, abdominal pain, rash, mouth and throat pain, dizziness, and joint pain.

The market for Obeticholic acid is driven by growing biliary cholangitis (PBC) cases and unmet needs in non-alcoholic steatohepatitis (NASH) fibrosis. The growing cases of obesity, diabetes epidemics, improved liver diagnostics, and FXR agonist efficacy as UDCA add-on therapy contribute to its market growth. The North American region leads its market because of strong R&D and patient access, while the Asia-Pacific region is driven by healthcare investments and rising metabolic disorders.

The high pricing, regulatory safety concerns, raw material supply instabilities, and limited competition affect industrial Obeticholic acid procurement. Other factors like speciality pharmacy channels, patient assistance programs, and vigilant monitoring of liver toxicity risks impact its sourcing strategies.

Raw Material for Obeticholic Acid Production

According to the Obeticholic Acid production plant project report, the key raw materials used in the production of Obeticholic Acid include (E)-3α-Hydroxy-6-ethylidene-7-keto-5β-cholan-24-oic acid (8-E) and ammonium chloride.

Production Process of Obeticholic Acid

The extensive Obeticholic Acid production cost report consists of the following major industrial production process:

1. By Hydrogenation: The production process for Obeticholic Acid starts with the E-isomer of 3α-hydroxy-6-ethylidene-7-keto-5β-cholan-24-oic acid. In this, the carboxylic acid group converts to an amide via coupling with ammonium chloride using PyBOP and a base in DMF. This amide intermediate then goes through a Pd/C-catalyzed hydrogenation in methanol to saturate the ethylidene double bond, followed by NaOH addition for epimerisation and partial hydrolysis under reflux. Then it goes through NaBH4 reduction under reflux to selectively reduce the 7-ketone to the 7α-hydroxy group while completing amide hydrolysis. The crude product is extracted into ethyl acetate after acidification, and final purification gives obeticholic acid as the final product.

Obeticholic acid appears as a white solid powder with the molecular formula C26H44O4 and molecular weight around 421 g/mol. It has a modified bile acid structure with 6-ethyl substitution, enhancing FXR agonist potency. It has a melting point of 108-110 degree Celsius and a boiling point above 500 degree Celsius. It has a density of around 1.09 g/cm³ and shows high solubility in DMSO and ethanol but poor water solubility. It has a predicted pKa around 4.8, reflecting carboxylic acid dissociation, and logP indicating lipophilicity suitable for oral absorption. It shows positive optical rotation in methanol, remains stable for years when stored at -20 degree Celsius, and demonstrates over 99% plasma protein binding with extensive hepatic metabolism.