Ritodrine

Preterm birth is a common complication during pregnancy. Globally, about 10% of newborns are born preterm, which is the leading cause of neonatal death and long-term disability. As a β₂-adrenergic receptor agonist tocolytic agent, ritodrine selectively activates the β₂ receptors on the cell membrane of uterine smooth muscle, reduces the intracellular calcium concentration, thereby relaxing the uterine smooth muscle, inhibiting uterine contraction and prolonging the pregnancy duration. It is clinically mainly used to prevent preterm birth after 20 weeks of gestation, and is currently the only tocolytic agent approved by the FDA for the indication of preterm birth. Under the premise that the benefit outweighs the risk after weighing, it is applicable to pregnant women with signs of preterm birth and no relevant contraindications.

Data show that in recent years, the global market size of preterm birth treatment drugs has exceeded 2 billion US dollars, among which tocolytic drugs account for about 35%, and the compound annual growth rate is maintained at around 4.2%. The domestic market size of ritodrine preparations is stable in the range of 1.2 billion to 1.5 billion yuan. The current market is dominated by generic drugs, and more than 20 domestic enterprises have obtained the approval documents for preparations. After the implementation of the centralized procurement policy, the terminal price has dropped by about 48%, and the clinical accessibility has been greatly improved, driving the steady growth of the demand for API.

The original research enterprise of ritodrine is Tanabe Mitsubishi Pharma from Japan, and the original brand name is "Yutopar". Its core compound patent expired in the 1990s, and all preparation patents in major markets have also expired. The original dosage forms include injection and tablet. The specification of the injection is 5ml:50mg, and the specification of the tablet is 10mg. The original preparation has been included in the China List of Marketed Drugs, and is a recognized reference preparation. Up to now, more than 15 domestic enterprises have obtained the A-status registration number for ritodrine API through the review and public announcement of CDE, and the marketing approval of domestic preparations has also been fully implemented, with a mature supply system. (Data as of July 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for ritodrine API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They can meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and provide stable reference standard support for pharmaceutical enterprises in API R&D, quality research and compliance declaration.