Propafenone

Arrhythmia is a high-incidence chronic disease in the cardiovascular field. If conditions such as supraventricular tachycardia and paroxysmal ventricular premature beats are not under standardized control, they will significantly increase the risk of stroke and heart failure. As a classic variety of Class Ic antiarrhythmic drugs, propafenone blocks sodium channels in cardiomyocytes, slows down the depolarization rate of phase 0 of the action potential, and prolongs the effective refractory period of the conduction pathway. It also has mild β-receptor and calcium channel blocking effects, and can be used for the prevention and treatment of supraventricular and ventricular ectopic beats, as well as supraventricular tachycardia associated with pre-excitation syndrome. It is a first-line medication option for arrhythmia patients without structural heart disease, and has been in clinical application for more than 30 years.

The global market size of propafenone preparations has stabilized at around US$1.2 billion in recent years, with a compound annual growth rate of approximately 2.1%. The growth rate of the Chinese market is slightly higher than the global average, remaining at around 3.5%. In terms of the competitive landscape, the domestic preparation market is dominated by generic drugs. More than 20 enterprises have obtained preparation approvals. Among them, oral immediate-release dosage forms have been included in the national centralized procurement catalog, and the winning bid price has dropped by approximately 68% compared with that before centralized procurement. On the API side, domestic manufacturers are concentrated in East China and South China. The annual output can meet domestic clinical demand, and about 30% of the production capacity is supplied to overseas generic drug manufacturers.

The original research enterprise of propafenone is Abbott, with the original brand name Rythmol. Its US compound patent expired in 1989, and the core compound patent in China has also expired. The original marketed dosage forms include 150mg and 300mg tablets, as well as 70mg/20ml injection. Both the original tablets and injection have been included in the FDA Reference Listed Drug Catalog, and the 150mg specification of the original tablets has been included in the *Catalog of Reference Preparations for Chemical Drugs* in China. Up to now, there have been 12 registration records of propafenone API on the API registration platform of China CDE, among which 8 have been activated and can be used for associated preparation declaration. 25 domestic enterprises have obtained marketing approval for propafenone preparations. (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 propafenone API, covering a total of 17 process impurities and degradation impurities. Most of the products are in stock. Orders placed before 16:00 can be shipped on the same day. All impurities meet the requirements of Chinese Pharmacopoeia and FDA regulations, and can support the full-process research needs of API process research, quality standard establishment and preparation consistency evaluation.