Ursodeoxycholic Acid

Cholestatic liver disease, as a common chronic hepatobiliary system disease in clinical practice, has long lacked specific treatment options, and this dilemma was not broken until the emergence of hydrophilic bile acid drugs. Ursodeoxycholic acid is currently the only orally administered drug clinically approved for the treatment of primary biliary cholangitis. It exerts its effects through multiple mechanisms such as inhibiting the intestinal reabsorption of hydrophobic bile acids, protecting cholangiocytes and hepatocytes from toxic damage, and regulating immune responses. In addition to primary biliary cholangitis, it can also be used for the treatment of cholesterol-type gallstones and bile reflux gastritis, covering multiple groups of patients with hepatobiliary diseases such as adults and children, and is one of the basic medications in the field of hepatobiliary diseases.

The global market size of ursodeoxycholic acid had exceeded USD 1.6 billion in 2023, and it is expected to grow to USD 2.1 billion by 2028 at a compound annual growth rate of 5.2%. As the world's major producer of ursodeoxycholic acid active pharmaceutical ingredients (APIs), China accounts for more than 70% of the global total production capacity. The domestic preparation market has formed a pattern where the original research drugs and generic drugs coexist. Since 2022, the average price reduction of relevant preparations in the centralized procurement of multiple provinces has exceeded 60%, which has further driven the growth of demand for cost-effective APIs in the downstream market.

The original research enterprise of ursodeoxycholic acid is Dr. Falk Pharma GmbH in Germany, with the original brand name Ursofalk. Its core compound patent expired globally in 1999. At present, the originally researched dosage form approved in China is mainly capsules, with the specification including 250 mg, which has been included in the *Catalogue of Reference Preparations of Chemical Drugs* issued by the National Medical Products Administration. As of now, ursodeoxycholic acid APIs from more than 60 enterprises in China have completed registration at the Center for Drug Evaluation (CDE) and obtained the A status label, and the total number of approved approval numbers for domestic ursodeoxycholic acid preparations has exceeded 80. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of ursodeoxycholic acid impurity reference standards, fully covering various impurities such as those generated during the synthesis process and degradation products. Most of the products are in stock, and orders for in-stock products placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs of API enterprises for quality research, impurity control, registration and declaration, etc.