Crotonic Acid

In the R&D of therapeutic drugs for chronic metabolic diseases and inflammation-related diseases, crotonic acid, as a key intermediate of small molecule organic acids and a pharmaceutically active ingredient, exerts anti-inflammatory and lipid metabolism regulating effects by targeting and regulating the G protein-coupled receptor 43 (GPR43) pathway. It can be used to prepare blood lipid-regulating and anti-intestinal inflammation preparations, and is also a core synthetic raw material for the skeleton materials of various sustained-release preparations, applicable to the relevant treatment regimens for patients with hyperlipidemia, chronic enteritis and other diseases. It is also a commonly used key starting material in the field of API synthesis.

At present, the global market size of crotonic acid is approximately USD 230 million, with a compound annual growth rate maintained at around 4.7%. The demand growth is mainly driven by the R&D of chronic disease drugs and the expansion of specialty generic drug pipelines. China is the world's main producer of crotonic acid, with its production capacity accounting for 62% of the global total. However, there is a long-term gap in the supply of high-end pharmaceutical-grade crotonic acid. At present, 3 domestic enterprises have completed API registration with CDE, and the competitive landscape is relatively concentrated. With the implementation of the associated review and approval system, there is still room for improvement in the market premium of compliant pharmaceutical-grade crotonic acid.

There is no unified global original research enterprise for crotonic acid. Domestic pharmaceutical-grade crotonic acid was first produced in compliant mass production by a chemical enterprise in Jiangsu Province. At present, all registered APIs in China are declared as generic drugs, with no corresponding original research trade name. Currently, a total of 7 registration numbers for pharmaceutical-grade crotonic acid APIs have been approved in China, among which 4 are in A status and can be directly associated with preparation declaration. Relevant products are not included in the reference preparation catalog. Domestic external anti-inflammatory preparations containing crotonic acid components have been approved for marketing, and no oral preparations have been approved yet. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for crotonic acid API. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. They comply with multiple regulations such as Chinese Pharmacopoeia and FDA, which can meet the reference standard requirements of the whole process of API R&D, quality research and registration declaration, and provide stable support for the compliant declaration and quality control of pharmaceutical enterprises.