Carboprost

Postpartum hemorrhage is the leading cause of maternal death worldwide, of which approximately 70% is caused by uterine atony. When conventional uterotonic therapy is ineffective, the clinical treatment window is extremely short. As a derivative of prostaglandin F2α, carboprost is a potent uterotonic drug. It can directly act on the prostaglandin receptors of uterine smooth muscle cells to stimulate the uterus to produce rhythmic contractions and rapidly close the blood sinuses at the placental attachment site, thereby achieving a hemostatic effect. Its indications mainly include refractory postpartum hemorrhage and uterine atony during labor induction. It can also be used for medical abortion in early pregnancy, and is especially suitable for high-risk pregnant women who have poor response to conventional uterotonic drugs such as oxytocin and ergometrine, and can significantly reduce the risk of hysterectomy.

At present, the global market size of carboprost is approximately US$280 million, with a compound annual growth rate maintained at around 4.2%. The growth momentum mainly comes from the improvement of obstetric first aid systems in developing countries and the popularization of postpartum hemorrhage prevention and treatment specifications. The Chinese market accounts for approximately 17%, with a growth rate higher than the global average, and its compound annual growth rate reaches 6.8%. In terms of the competitive landscape, the original research product accounts for approximately 62% of the domestic market share. In recent years, with the advancement of consistency evaluation, the market share of domestic generic preparations has gradually increased. At present, preparations from 3 domestic enterprises have passed the consistency evaluation of generic drugs, with prices approximately 40% lower than that of the original research product, and their penetration rate in medical institutions at all levels continues to rise.

The original research enterprise of carboprost is Pharmacia & Upjohn, and the original trade name is Hemabate. The core compound patent of the original research expired in the United States in 2019, and the relevant preparation patent in China expired in 2021. The main dosage form of the original research is injection, with a specification of 1ml:250μg. It has been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China, and is also a reference preparation announced by the FDA. In terms of domestic API registration, 6 carboprost API registration numbers can be queried on the CDE platform at present, of which 3 are in status A and can be used for associated preparation review; a total of 5 carboprost tromethamine injection varieties, including the original research and domestic generics, have been approved for marketing in China. (Data as of June 2025, please refer to the official CDE website for the latest information)

In response to the quality control needs of carboprost, CATO can provide a full set of impurity reference standards for this API, covering all key impurity sites such as synthetic process intermediates and degradation products. Most products are in regular stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All reference standards meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the needs of pharmaceutical enterprises in drug R&D, quality research and routine release testing.