Cholic Acid

Overview

ICE Pharma is a leading manufacturer of Cholic Acid API, a primary human bile acid synthesized from cholesterol in the liver. It is one of the two major bile acids produced by the liver (the other being chenodeoxycholic acid), where it appears in bile as either its glycine or taurine conjugates. Our GMP-compliant Cholic Acid is derived from bovine bile using a robust extraction and purification process, ensuring high purity and full traceability in compliance with BSE/TSE regulations.

ICE Pharma manufactures two high purity grades of cholic acid: an Intermediate and an API Grade, both produced under strict GMP-compliant conditions. Our advanced extraction and purification process yields industry-scale quantities of high-purity cholic acid, meeting stringe

Applications

• Pharmaceutical Intermediate: Cholic Acid serves as a precursor in the synthesis of Ursodeoxycholic Acid (UDCA), an API widely used for several indications, including the treatment and prevention of liver diseases and the dissolution of gallstones.
• Treatment of Bile Acid Synthesis Disorders: As an active pharmaceutical ingredient (API), Cholic Acid is utilised in therapies for inborn errors of bile acid metabolism, offering effective treatment options for patients with bile acid synthesis disorders.
• Ingredient: In traditional and modern Chinese medicines
• Excipient in drug formulations: Cholic Acid can aid to enhance the solubility and stability of poorly water-soluble drugs, peptides, and proteins, while facilitating their permeation across biological membranes.

Manufacturing and Quality Assurance

Our production facilities in New Zealand and Italy adhere to stringent GMP standards, ensuring the highest level of quality and safety in every batch of Cholic Acid API. For example, our NZP secure packaging in 25 kg polyethylene plastic/foil liners within Darbox containers maintains product integrity during storage and transport.

Regulatory Compliance

Our commitment to quality, compliance, and safety ensures that our Cholic Acid API meets global pharmaceutical industry standards, making it a reliable choice for pharmaceutical applications worldwide.