Ethinylestradiol

As a classic variety of steroidal hormone drugs, ethinylestradiol is a potent estrogen derivative. Its mechanism of action is to bind to estrogen receptors to regulate the hormone secretion of the hypothalamic-pituitary-gonadal axis, while inhibiting ovulation and increasing the viscosity of cervical mucus. In clinical practice, it is mainly combined with progestogens to form compound oral contraceptives, and can also be used to treat perimenopausal syndrome, functional uterine bleeding, female gonadal dysplasia and other diseases. It is a core basic drug in the global reproductive health field and endocrine therapy field, covering the needs of multiple groups of people such as childbearing age contraception and menopausal symptom management.

The global market size of ethinylestradiol API is stable at around USD 320 million, with a compound annual growth rate maintained at 2.1%, showing significant rigid demand characteristics. China is the world's largest producer and exporter of ethinylestradiol, with production capacity accounting for more than 65% of the global total. The products of leading domestic manufacturers supply nearly 100 countries and regions such as Europe, America and Southeast Asia. In the centralized procurement of domestic preparations, the winning bid price of compound oral contraceptives containing ethinylestradiol decreased by an average of 42% compared with the previous round, further driving the demand for upstream APIs to concentrate on compliant leading production capacity.

The original research enterprise of ethinylestradiol is Pfizer, and the original trade name is Estinyl. The core compound patent expired globally in 1968. At present, the mainstream dosage form includes oral tablets, with common specifications of 0.01mg and 0.05mg. The original preparation has been included in the FDA Reference Listed Drug Catalog. As of the retrieval time point, there are 8 ethinylestradiol API registration records on the API registration platform of China CDE, among which 5 are in status A (approved for use in marketed preparations); a number of compound oral contraceptive preparations containing ethinylestradiol have been approved for marketing in China. (Data as of June 2025, please refer to the official website of CDE for the latest information)

In response to the R&D and quality control needs of ethinylestradiol, CATO provides a full set of impurity reference standards for this API. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. They fully comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can effectively support enterprises in carrying out generic drug consistency evaluation, quality standard research and routine release testing.