Oxytocin

Postpartum hemorrhage is the leading cause of maternal death worldwide, and timely application of uterine contraction drugs in clinical treatment is the core link to reduce mortality. Oxytocin is a polypeptide类 uterine contraction drug, which binds to oxytocin receptors on uterine smooth muscle to promote rhythmic uterine contraction and compress blood vessels in the uterine myometrium to achieve hemostatic effect. It can also be used for labor induction, oxytocic, and uterine bleeding caused by uterine atony or poor involution after delivery and abortion. It is an essential first-aid drug in obstetric clinical practice, covering obstetric diagnosis and treatment scenarios of medical institutions at all levels.

As a basic obstetric drug, the global market size of oxytocin is approximately USD 870 million, with a compound annual growth rate of around 4.2% from 2023 to 2029; the market size in China exceeds RMB 1.2 billion, among which the annual growth rate of API demand is about 3.8%. At present, the domestic oxytocin preparation market is dominated by generic drugs, and nearly 30 enterprises have been approved to produce preparations. After the centralized procurement, the price of in-hospital preparations has dropped to RMB 0.4 to 1.5 per vial, and cost control has become the core competitiveness of downstream preparation enterprises. The stability and purity of upstream API supply directly affect the quality control level and supply guarantee capability of preparations.

The original research enterprise of oxytocin is Pfizer, with the original trade name Pitocin, which was first approved for marketing in the United States in 1953, and all core compound patents have expired. At present, the domestically approved original dosage form is injection, with specifications including 1ml:5 units and 1ml:10 units, which has been included in the *Catalogue of Reference Preparations for Chemical Drugs* issued by the National Medical Products Administration. Up to now, there are 11 valid registration entries of oxytocin API on China CDE API Registration Platform, 8 of which are in Status A and can be used in association with domestic preparation declarations. A total of 27 domestic enterprises have been approved to produce oxytocin injection. (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 oxytocin API, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can provide full-chain reference standard support for API and preparation enterprises in quality research, stability study, and registration declaration.