Clomifene

In the field of infertility treatment, clomiphene is currently one of the most widely clinically used non-steroidal ovulation-inducing drugs, belonging to selective estrogen receptor modulators. Its mechanism of action is to competitively bind to estrogen receptors in the hypothalamus, block the negative feedback effect of endogenous estrogen, promote the secretion of gonadotropin-releasing hormone, and then stimulate follicular development. It is mainly clinically used for the treatment of anovulatory female infertility and luteal phase deficiency, and can also be used for the adjuvant treatment of male infertility caused by oligospermia and asthenospermia. It is a first-line basic drug for assisted pregnancy treatment in the field of reproductive medicine.

The global clomiphene market size has maintained a stable growth trend for a long time. In 2023, the overall market size was approximately USD 270 million, with a compound annual growth rate maintained at around 3.2%. China is the main producer and supplier of clomiphene active pharmaceutical ingredients (APIs), accounting for nearly 65% of the global production capacity share. The domestic generic drug preparation market has now formed a pattern of joint competition among multiple enterprises. After the implementation of centralized procurement, the terminal price of preparations has dropped by more than 70%, which has further driven the improvement of clinical accessibility, and the growth rate of drug demand in primary medical institutions has exceeded 8% for three consecutive years.

The original research enterprise of clomiphene is Sanofi-Aventis, and the original research brand name is "Clomid". Its core compound patent expired globally in 1983. The main dosage form approved for the original research product is tablet, with a specification of 50mg, which has been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs*. Up to now, there are a total of 7 clomiphene API registration entries on the platform of the Center for Drug Evaluation of China, among which 5 have been registered in Status A. Multiple domestic enterprises have already obtained approval for the marketing of clomiphene tablets. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of clomiphene impurity reference standards. Most products are in regular stock. For in-stock orders placed before 16:00, delivery can be made on the same day. All products meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for API manufacturers, preparation R&D institutions and quality testing departments.