Mexiletine

As a classic Class Ⅰb antiarrhythmic drug, mexiletine exerts its effects by blocking sodium channels in cardiomyocytes and shortening the action potential duration. It is mainly used clinically for the treatment of chronic ventricular arrhythmias, including ventricular premature beats, ventricular tachycardia, etc., especially suitable for patients with ventricular arrhythmias combined with organic heart disease. It is a commonly used basic antiarrhythmic drug in primary diagnosis and treatment at present, with the advantages of definite efficacy and high safety, and long-term clinical application has accumulated sufficient real-world evidence.

At present, the market size of antiarrhythmic drugs in China has exceeded 9 billion yuan, among which oral antiarrhythmic drugs account for about 42%. As a first-line drug recommended by primary diagnosis and treatment guidelines, mexiletine has maintained a compound annual market growth rate of about 5.8% in the past three years. The current domestic market is dominated by generic drug supply. Nearly 30 enterprises hold the approval documents of mexiletine preparations, among which the oral immediate-release dosage forms have been included in the 7th batch of national centralized drug procurement, and the price cut of the selected products has exceeded 70%, driving the continuous and stable release of demand for active pharmaceutical ingredients (APIs), and the upstream supply side has achieved complete localization.

The original research enterprise of mexiletine is Boehringer Ingelheim Pharmaceuticals, with the original brand name Mexitil, and its compound patent for the US market expired in 1990. The main dosage forms of the original product are oral tablets, with specifications including 50mg, 100mg and 200mg, which have been included in the FDA Reference Listed Drug Catalog, and the original preparation has not been imported into China at present. In terms of domestic API registration, 9 enterprises have obtained CDE registration numbers for mexiletine APIs with the status of "A", which can supply domestic preparation production; on the preparation side, multiple varieties such as mexiletine hydrochloride tablets and mexiletine hydrochloride injection have been approved for marketing. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for mexiletine API, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products fully comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can provide stable reference material support for API R&D, quality research and consistency evaluation work.