Norethisterone

Progestogen drugs are one of the core categories for the treatment of gynecological endocrine diseases. As a representative variety of first-generation oral progestogens, norethisterone binds to progesterone receptors to inhibit the hypothalamic-pituitary-ovarian axis, and at the same time transforms the endometrium from the proliferative phase to the secretory phase. It can also inhibit ovulation and increase the viscosity of cervical mucus. Clinically, it is mainly used for the treatment of dysfunctional uterine bleeding, endometriosis and irregular menstruation. It can also be combined with estrogen for contraception in women of childbearing age, and the applicable population covers patients with related gynecological diseases from adolescence, childbearing age to perimenopause.

At present, the global market size of norethisterone API is about USD 120 million, with a compound annual growth rate of 3.8% in the past five years. The domestic market size is about RMB 230 million. Driven by the increase in the diagnosis and treatment rate of gynecological diseases and the growing demand for short-acting contraception, the growth rate is expected to reach 4.2% in the next three years. The competition landscape shows that "China is the world's largest main production area of norethisterone API, and the production capacity of domestic enterprises accounts for more than 65% of the total global production capacity. The demand of leading generic drug preparation enterprises is stable. Centralized procurement-related preparations have been included in the fourth batch of national centralized procurement catalog, and the price of selected products has dropped by about 58%, which further drives the steady increase in the demand for upstream APIs."

The original research enterprise of norethisterone is Pfizer, with the original research trade name Norlutate. The core compound patent expired globally in 1986. The current mainstream dosage forms include tablets and injections. The common oral dosage form specifications are mainly 0.625mg, 2.5mg and 5mg. The original research tablet has been included in the FDA Reference Listed Drug catalog, and is also listed as a reference preparation. According to the domestic API registration platform, 12 domestic enterprises have obtained A-status registration numbers for their norethisterone APIs. In addition, 3 enterprises' norethisterone tablets and 1 enterprise's compound norethisterone tablets have been approved for marketing. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for norethisterone API, supporting multi-grade products such as preparation grade and analytical grade. Most of the products are in sufficient stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the impurity对标 requirements of pharmaceutical enterprises in the whole process of API R&D, quality research and quality control.