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News! Our exclusive agent of specialty imported API Carboprost Tromethamine passed CDE!

来源:本站发布时间:2022-09-09 11:03:55[关闭][打印]

Product Description
Chinese Name:卡前列素氨丁三醇
English Name:Carboprost Tromethamine
Chemical name:(15S)-15-Methyl prostaglandin F2α aminotriol salt
Chemical formula:C25H47NO8
CAS No.:58551-69-2
Formulations and specifications:Injection solution, 1ml: 250ug
Original research:Pharmacia and Upjohn Company;
Trade name: Xinmupe
Indications: For mid-term pregnancy abortion, for postpartum hemorrhage due to uterine relaxation where conventional management has failed.

Domestic registration status
Formulation declaration registration status Quantity Raw material filing Quantity
China Domestic Approval 2 Domestic approved A 2
Import approval 1 Import Registration I 1
China Domestic Registration 3 Domestic approved A 2 (Chinoin and MSN)
Import Registration 5.2 1 Registration in Hong Kong, Macau and Taiwan I 1





Preferred medicine for postpartum bleeding
Postpartum hemorrhage refers to vaginal bleeding of more than 500 ml within 24 hours after delivery of the fetus, commonly known as postpartum hemorrhage or postpartum hematemesis. Postpartum hemorrhage is a serious complication during childbirth and ranks among the top four causes of maternal death in China. The incidence of postpartum hemorrhage accounts for 3%-5% of all deliveries, and the actual incidence is higher because the amount of blood loss is usually estimated to be only half of the actual amount of blood loss due to the subjective factor of measuring and collecting the blood volume.
In general, oxytocin can be used as a first-line prophylactic agent, as it is fast-acting but short-lived and must be followed by longer-lasting uses or other drugs with longer effective concentration maintenance.
When one contraction agent is not effective, it should be immediately switched to another contraction agent; when contractions are not effective, Carboprost Tromethamine is effective in promoting uterine contractions and thus reducing postpartum bleeding.
Carboprost Tromethamine is used as the drug of choice in high-grade mothers with postpartum hemorrhage such as weak contractions, poor oxytocin induction of labor, excessive uterine distension, placenta praevia or placenta abruptio.

Clinical advantages
Inducing strong and coordinated contractions of the uterine musculature to perform hemostatic and labor-inducing functions.
Rapid onset of action, with one effect and remarkable efficacy.
Safe and reliable, with mild adverse effects.
Preventive medicine for high-risk women and women with bleeding tendency
First choice for emergency postpartum hemorrhage
Recommended medication for midterm induction of labor

Market Prospects
Compared with similar varieties, Carboprost Tromethamine has faster onset of action, longer duration, stronger action and fewer side effects.

* According to the data from minet, the market volume of Carboprost Tromethamine injection in 2021 is about 650 million yuan and is included in the national Class B medical insurance in 2021. With the increasingly favorable medical environment under the national policy of encouraging childbirth, it is believed that there will be a better market prospect for Carboprost Tromethamine injection.

Exclusive raw material advantages
Carboprost Tromethamine belongs to the prostaglandin class, and the synthesis process is very difficult.
MSN has passed the CDE technical review with status A. It is the only imported material that has passed the review except for the original research.
MSN has a US DMF, No. 27865 (A), and is the only generic ingredient approved for marketing in the United States.
MSN will also apply for registration in Europe and Japan to provide more market services to our customers.
MSN raw material global supply, to ensure the quality and supply after commercialization, and Europe and the United States for the same production line, can support domestic customers, preparations in Europe and the United States at the same time to declare.
Batch size 100g/batch.