Misoprostol

As a prostaglandin E1 derivative commonly used in clinical obstetrics and gynecology, misoprostol exerts potent effects of uterine contraction, mucosal protection and cervical softening by specifically binding to prostaglandin receptors on uterine smooth muscle and gastrointestinal smooth muscle. In clinical practice, it is often used sequentially in combination with mifepristone to terminate early pregnancy, and can also be used to prevent and treat postpartum hemorrhage, gastric ulcer and duodenal ulcer. It is also included in the WHO List of Essential Medicines, and is an indispensable basic medicine in the fields of reproductive health and digestive diseases, with applicable population covering a wide range of groups such as women of childbearing age and patients with peptic ulcer.

At present, the global annual market size of misoprostol is approximately USD 1.8 billion, with a compound annual growth rate of 6.2% in the recent 3 years. The demand growth mainly comes from the improvement of reproductive health service systems in developing countries and the increase of penetration rate in postpartum hemorrhage prevention and treatment scenarios. The domestic market size is approximately RMB 1.2 billion, of which generic drugs account for more than 90% of the market. There are currently 7 preparation enterprises that have passed the consistency evaluation. Since 2022, multiple provinces have included it in the centralized procurement scope, with an average price reduction of 58% for winning bids. The upstream API supply has long been dominated by domestic local manufacturers, and the import substitution rate has exceeded 95%.

The original research enterprise of misoprostol is Pfizer, with the original research brand name "Cytotec". Its core compound patent in the United States expired in 1999, and the compound patent in China expired in 2000. The original marketed dosage forms include oral tablets with a specification of 0.2mg, which have been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China, and also listed in the FDA Reference Preparations Catalogue. At present in China, misoprostol APIs from 23 enterprises have obtained Class A status through CDE registration, and oral preparations from another 11 enterprises have been approved for marketing, among which 7 have passed the consistency evaluation. (Data as of November 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of misoprostol impurity reference standards. Most products are in stock. For in-stock products, orders placed 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 meet the reference substance use needs of the whole process including API R&D, quality research, consistency evaluation, etc.