Levonorgestrel

Unintended pregnancy is one of the core concerns in the global reproductive health field. As a second-generation progestogen drug, levonorgestrel acts through a triple mechanism of inhibiting ovulation, changing the viscosity of cervical mucus to prevent sperm penetration, and interfering with endometrial morphology to affect the implantation of fertilized eggs, making it the most widely used core drug for emergency contraception in clinical practice at present. In addition to emergency contraception, this ingredient can also be combined with estrogen to form compound oral contraceptives, and can also be used for the treatment of gynecological diseases such as irregular menstruation, dysfunctional uterine bleeding and endometriosis. Its applicable population covers women of childbearing age with contraceptive needs and patients with related gynecological diseases, and its clinical application scenarios cover three major fields: daily contraception, post-coital remedy and gynecological disease treatment.

The global market size of levonorgestrel-related preparations is approximately USD 3.2 billion, with a compound annual growth rate of approximately 4.2% from 2023 to 2028, and the emergency contraception scenario is the main growth driver. In terms of the domestic market, levonorgestrel is among the first batch of contraceptive drugs included in the over-the-counter drug catalogue, with the retail end accounting for more than 75%. There are more than 30 domestic preparation manufacturers, among which the CR2 of the retail market for emergency contraceptives exceeds 60%. The centralized procurement price has dropped to less than RMB 1 per tablet, which has greatly improved the accessibility of the drug. On the API supply side, domestic production capacity accounts for more than 70% of the global total, making China a major exporter.

The original research enterprise of levonorgestrel is Bayer Healthcare, and the original brand names are "Yuting" (single-agent emergency contraceptive dosage form) and "Yasmin" (compound oral contraceptive dosage form containing levonorgestrel). Its core compound patent expired globally in 1999. The main marketed dosage forms in China include 0.75mg and 1.5mg single-agent tablets, as well as compound tablets combined with ethinylestradiol. Among them, the 0.75mg and 1.5mg single-agent preparations have been included in the Catalogue of Marketed Drugs in China as reference listed drugs. Up to now, there are more than 20 registration records of levonorgestrel APIs on the domestic CDE API registration platform, of which 15 have been converted to A status and can be associated with the marketing declaration of domestic preparations, and the number of approved domestic preparations exceeds 80. (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 levonorgestrel, which can cover the whole-process quality control requirements from API synthesis to preparation stability research. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia and FDA, and can be directly used for research related to registration and declaration.