Mifepristone

For the clinical needs of terminating early pregnancy, mifepristone is a highly representative progestogen receptor antagonist drug. It competitively binds to the progestogen receptors in the endometrium and decidual tissue to block the physiological effect of progestogen, leading to degeneration and necrosis of decidual tissue and softening and dilation of the cervix. It is often used sequentially and in combination with prostaglandin drugs to terminate intrauterine pregnancy within 49 days of amenorrhea, and can also be applied in scenarios such as labor induction, adjuvant treatment of endometriosis and emergency contraception. It covers the reproductive health-related medication needs of women of childbearing age at different stages, and is one of the core medications in the field of reproductive health.

The global mifepristone market size is approximately USD 1.8 billion, with a compound annual growth rate of around 4.7% from 2023 to 2029. The growth drivers mainly come from the improvement of the accessibility of reproductive health medications and the expansion of clinical indications. The domestic market is dominated by generic drugs, with a relatively concentrated overall competitive landscape, and the market share of domestic preparations exceeds 90%. Meanwhile, this variety has been included in the National Medical Insurance Class A Catalog, and the demand for medication at public medical institution terminals is stable. In recent years, with the improvement of the reproductive health service system, the demand in the primary market has shown a steady upward trend.

The original research enterprise of mifepristone is Roussel Uclaf, a French company, and the original brand name is Mifegyne. Its core compound patent expired in Europe in 2000, and the core patent in the United States expired in 2007. The main dosage form of the original research product on the market is tablet, with specifications of 200mg and 25mg. The 200mg specification has been included in the FDA Reference Listed Drug Catalog, and the original research preparation has not been imported into China. At present, more than 30 domestic enterprises have obtained approval for the marketing of mifepristone preparations. The CDE API registration platform shows that there are 12 domestic mifepristone API registration numbers, most of which are in status A and can be supplied for domestic preparation production. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full range of mifepristone impurity reference standards. Most products are in regular stock, and orders placed before 16:00 can be shipped on the same day. All products comply with the regulatory requirements of multiple countries including the Chinese Pharmacopoeia and FDA. The impurity purity and structural characterization data are complete, which can fully meet the full-process R&D and production needs of API and preparation enterprises, such as quality research, stability study and impurity declaration.