Quinidine

As a representative variety of classic antiarrhythmic drugs, quinidine is a Class Ⅰa sodium channel blocker. By inhibiting sodium influx on the myocardial cell membrane, it prolongs the action potential duration and effective refractory period, and reduces myocardial automaticity and conduction velocity. It is a broad-spectrum antiarrhythmic drug recommended by guidelines. Its clinical indications cover various types of arrhythmias such as atrial premature beats, atrial fibrillation, paroxysmal supraventricular tachycardia, ventricular premature beats and ventricular tachycardia. It is especially suitable for long-term maintenance treatment of arrhythmia patients without organic heart disease, and also has irreplaceable clinical value in the intervention of special types of arrhythmias such as short QT syndrome.

The current global quinidine market is approximately USD 120 million. Driven by the expansion of rare disease indications and the increase in the penetration rate of primary-level arrhythmia diagnosis and treatment, the compound annual growth rate in the past three years has remained at 4.2%. In terms of the domestic market, due to the long clinical use time of this drug, a pattern dominated by generic drug supply has been formed at present, with an overall market size of approximately RMB 87 million. The supply of active pharmaceutical ingredients (APIs) has long been dominated by domestic enterprises, and the import substitution rate has reached more than 95%. At present, this variety is not included in the scope of national centralized volume-based procurement, the market price system is relatively stable, and the profit margin of manufacturers is in a reasonable range.

The original research enterprise of quinidine is Stada Arzneimittel AG, Germany, and the original research trade name is "Quinidine Sulfate". Its core compound patent expired worldwide in 1985. At present, the main dosage form of the original research product on the market is quinidine sulfate tablets with a specification of 200mg. This product has been included in the FDA Reference Listed Drug (RLD) Catalog, and the original research product is not included as a reference listed drug in China. In terms of domestic API registration, there are currently 3 enterprises whose quinidine sulfate APIs have passed the approval of the Center for Drug Evaluation (CDE) and obtained A-status registration numbers, and quinidine sulfate tablets produced by domestic enterprises have been approved for marketing. (Data as of November 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full range of quinidine impurity reference standards, covering all research needs such as process impurities and degradation impurities. Most products have sufficient stock reserves, and in-stock products ordered before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard use needs of all links of API research and development, production and quality control.