Medroxyprogesterone

Progestogens are the core category of drugs for clinical regulation of reproductive endocrine and treatment of hormone-dependent diseases. Medroxyprogesterone, as a representative variety of synthetic progestogens, exerts effects by strongly binding to progesterone receptors, inhibiting the function of the hypothalamic-pituitary-gonadal axis to reduce estrogen production, and directly acting on the endometrium to inhibit abnormal proliferation of the intima. In clinical practice, it is not only used for the treatment of gynecological diseases such as amenorrhea, dysfunctional uterine bleeding and endometriosis, but also can be used as a palliative treatment for patients with hormone-sensitive advanced breast cancer and endometrial cancer. It can also be combined with estrogen for hormone replacement therapy of perimenopausal syndrome. The applicable population covers gynecological patients of all age groups from childbearing age to postmenopausal period, as well as some patients with advanced hormone-related tumors.

The global medroxyprogesterone market size has maintained steady growth in recent years. In 2023, the overall market size was approximately USD 480 million, of which generic drugs accounted for more than 90%. The Chinese market is the main growth engine, with a compound annual growth rate of 7.2% in the past three years, and the domestic market size in 2023 was approximately RMB 520 million. In terms of competitive landscape, the domestic preparation market is dominated by local pharmaceutical companies, while API production is concentrated in compliant manufacturers in East China and North China. After the implementation of volume-based procurement, the price of preparations has dropped by more than 60%, and the supply stability and quality compliance of upstream APIs have become the source of core competitiveness for downstream enterprises.

The original developer of medroxyprogesterone is Pfizer, with the original brand name Provera. It was first approved for marketing in the United States in 1959, and the core compound patent has expired globally. The mainstream dosage forms of the original product include tablets and injections, among which the tablet specifications are 2.5mg, 5mg, 10mg, 200mg and 500mg, and the injection specification is 150mg/mL. The original tablets have been included in the *Catalogue of Reference Preparations for Chemical Drugs* issued by NMPA, and are also included in the FDA Reference Preparations Catalogue. Up to now, 12 domestic enterprises have obtained A status for their medroxyprogesterone APIs through CDE registration, and another 3 are in the publicity stage. The domestically approved preparations cover multiple dosage forms such as conventional tablets, dispersible tablets and injections. (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 medroxyprogesterone API. Most products are available in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the full-process compliance needs of pharmaceutical enterprises from API R&D, quality research to consistency evaluation.