Cloprostenol

As a core variety of prostaglandin reproductive regulation drugs, cloprostenol acts specifically on smooth muscle and luteal cells, powerfully dissolves the corpus luteum and promotes uterine smooth muscle contraction, while dilating the cervical os. It has irreplaceable clinical value in both animal husbandry and human reproductive medical fields. In the veterinary field, it is mainly used for synchronous estrus, induced parturition, treatment of persistent corpus luteum and endometritis in livestock such as cows and sows; in the human field, it is used as an adjuvant for artificial insemination, early pregnancy termination and intervention of postpartum incomplete uterine involution, and is a rigid-demand drug in the industrial chain of reproductive health and livestock and poultry breeding.

The global cloprostenol market size was approximately USD 210 million in 2023, and is expected to grow at a compound annual growth rate of 6.2% to USD 280 million by 2028. The growth drivers mainly come from the increasing penetration rate of large-scale farming and the expanding demand for human assisted reproduction. Driven by the veterinary drug centralized procurement policy in the domestic market, the winning bid price of cloprostenol preparations in 2024 decreased by approximately 32% compared with that before centralized procurement, while the drug consumption increased by 47% simultaneously. At present, domestic generic drugs have occupied more than 90% of the domestic veterinary market share, and human preparations are still dominated by imported original research drugs.

The original research enterprise of cloprostenol is Pfizer, and the original research trade names are "Lutalyse" (veterinary use) and "Planaprost" (human use). Its core compound patent expired globally in 1992. At present, the main marketed dosage forms of the original research include veterinary injections (0.2mg/2ml, 0.5mg/10ml) and human injections (250μg/1ml). Among them, multiple specifications of veterinary injections have been included in the FDA Reference Listed Drug Catalog, and human preparations have not been included in the China Listed Drug Catalog. As of July 2025, there are a total of 12 cloprostenol API registration information on the CDE API registration platform, of which 8 are in status A (approved for use in marketed preparations). The domestically approved cloprostenol preparations on the market cover two categories: veterinary injections and human injections. (Data as of July 2025, please refer to the official CDE website for the latest information)

In response to the quality research and compliance declaration needs of cloprostenol, CATO provides a full set of impurity reference standards for this API. Most products are in stock, in-stock products ordered before 16:00 will be shipped on the same day, and they meet the requirements of multiple regulations including Chinese Pharmacopoeia and FDA. They can fully cover the reference standard use needs of the whole process of API R&D, production and registration, and help enterprises efficiently pass various compliance audits.