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Cholic Acid is manufactured at our Palmerston North headquarters in our state-of-the-art GMP facility. NZP specialises in manufacturing high purity products, with our Cholic Acid being of >99% purity, and with product quality being established and ensured by our world class Quality Control and Quality Assurance departments. Given that our product finds applications in many different markets, NZP can offer a range of specifications to ensure that NZP Cholic Acid meets with each customer’s requirements.
Cholic acid is manufactured from bovine bile using a fully validated manufacturing process that has been approved by the EDQM as complying with EP Monograph 5.2.8 “Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products” which is identical to the Note for Guidance EMA/410/01 rev.3. As part of compliance with this monograph all bile raw material is sourced from government approved abattoirs with pre and post-mortem veterinary inspection. Even with the negligible risk of infectivity posed by bovine bile NZP’s processing conditions have been designed specifically to inactivate any transmissible agents present in the raw material.
NZP’s Cholic Acid manufacturing process and facility have been assessed by the New Zealand Regulatory Body (Medsafe) against the New Zealand Code of Good Manufacturing Practice (GMP) which is equivalent to the PIC/S guidelines and ICH Q7. Medsafe have subsequently granted NZP a GMP Certificate and Medicines Licence for this product. This guarantee of reliable product quality, the high purity of our product, and our commitment to the security of our customers’ supply chains makes NZP’s Cholic Acid the most reliable product in the market.
Applications of Cholic Acid
Cholic Acid is a natural product, produced from cholesterol in the liver of many animals, including humans. Typically, the liver converts cholesterol into the conjugated forms of cholic acid, glycocholic and taurocholic acid. These are then released into the small intestine where it was originally thought they served primarily to emulsify fats and promote digestion. However, recent research has shown the impact of bile acids on many different signalling pathways both inside and outside the gastro-intestinal system, leading to a resurgence of interest in bile acids as therapeutic molecules. NZP is at the forefront of many of these efforts, supplying cholic acid and various other bile acid derivatives to the pharmaceutical and biotechnology sector.
The primary industrial use of Cholic Acid is as an intermediate for the production of ursodeoxycholic acid (UDCA, Ursodiol), an active pharmaceutical ingredient which is used to treat several indications including Primary Biliary Cholangitis (also known as Primary Biliary Cirrhosis or PBC), the dissolution of gall stones and the liver damage caused by Hepatitis C infection.
Cholic Acid itself is also used as an active pharmaceutical ingredient for the treatment of bile acid synthesis disorders and is approved for use in both the US and Europe.
In addition, Cholic Acid also sees use in Traditional and Modern Chinese medicines, as an intermediate in the synthesis of various other pharmaceutical products and as an ingredient in culture and bio-relevant media.