Methylergometrine

Postpartum hemorrhage is the leading cause of maternal death worldwide, and the clinical application of potent uterotonic drugs is the core intervention to reduce mortality. Methylergometrine belongs to the ergot alkaloid class of uterotonic agents. By selectively agonizing 5-hydroxytryptamine and α-adrenergic receptors on the uterine smooth muscle, it rapidly induces tonic contraction of the uterus, which directly compresses the blood vessels in the uterine myometrium to achieve hemostasis. Compared with ordinary oxytocin, it has a stronger contractile effect on the lower uterine segment, with an onset time of only 2-3 minutes and a duration of action of up to 3 hours. Clinically, it is mainly used for the prevention and treatment of hemorrhage caused by uterine atony after delivery and abortion, and can also be used for the adjuvant treatment of subinvolution of the uterus. The applicable population includes women of childbearing age who have undergone vaginal delivery, cesarean section and various types of pregnancy termination surgeries.

The current global market size of postpartum hemostatic drugs is approximately USD 2.3 billion, with a compound annual growth rate maintained at 4.7%, among which ergot-type uterotonic agents account for about 18% of the overall postpartum hemostatic drug market. In terms of the domestic market, methylergometrine is included in the National Essential Medicines List. In 2022, its terminal sales in domestic public medical institutions exceeded RMB 120 million, with an annual growth rate of 29%. In terms of the competitive landscape, the current domestic preparation market is jointly supplied by imported original research drugs and a small number of domestic generic drugs, while there is still a certain supply gap in the API segment. Coupled with the advancement of centralized procurement of obstetric and gynecological drugs, the demand for compliant and high-quality APIs continues to rise.

The original research enterprise of methylergometrine is Novartis Pharma AG of Switzerland, with the original brand name Methergin®. The core compound patent of the drug expired globally in 1999. The main dosage form approved for the original drug is injection, with a specification of 0.2mg/1ml. It has been included in the China Listed Drug Catalogue as a reference preparation, and is also listed in the FDA Reference Listed Drug Directory. In terms of domestic API registration, as of now, 1 imported API and 2 domestic APIs with A-status registration numbers can be found on the CDE platform, and multiple pharmaceutical companies have been approved to produce methylergometrine injection preparations. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for methylergometrine API. The products fully meet the quality control requirements under multiple regulatory systems such as the Chinese Pharmacopoeia and FDA. Most impurities have sufficient spot inventory, and orders placed before 16:00 can be shipped on the same day. CATO can provide stable and reliable reference standard support for the whole process of API R&D, quality research and declaration of pharmaceutical enterprises.