Solriamfetol

There has long been a difficulty in balancing safety and compliance for antiarrhythmic drugs in the field of cardiovascular diseases. As a new Class III antiarrhythmic drug, sotalol selectively blocks potassium channels in cardiomyocytes, prolongs the action potential duration and effective refractory period, and also has a weak β-receptor blocking effect, which not only reduces the proarrhythmic risk of traditional Class III drugs, but also decreases the adverse reactions caused by off-target effects. It is mainly clinically used for the treatment of rhythm disorders such as atrial premature beats, ventricular premature beats, and paroxysmal atrial fibrillation, and is suitable for adult patients who are intolerant or have poor response to conventional antiarrhythmic drugs. Its clinical value has been verified in a number of evidence-based studies.

Sotalol is currently in the early stage of commercialization in the global market, and publicly available scale data has not been disclosed yet. With the continuous expansion of the base of arrhythmia patients and the upgrading of clinical demand for safer antiarrhythmic drugs, the potential market growth space of this drug has received extensive attention from the industry. In terms of the competitive landscape, only a small number of pharmaceutical companies have laid out related pipelines at present, and no generic drug manufacturer has applied for marketing approval. The overall competitive environment is relatively relaxed, and enterprises with first-mover advantages are expected to quickly occupy market share.

The original research enterprise of sotalol is Boehringer Ingelheim of Germany, and the original brand name is Multaq. Its US compound patent expired in 2021, and the core compound patent in China expired in 2022. The main dosage form of the original product is tablet with a specification of 400mg, which has been included in the FDA Reference Listed Drug Catalog, and also included in China's *Catalogue of Reference Preparations for Chemical Drugs (Third Batch)*. At present, the sotalol API of a number of domestic enterprises has been registered through the CDE, and 400mg sotalol tablets from multiple manufacturers have been approved for marketing. (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 sotalol API, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, can fully meet the reference standard use needs of pharmaceutical enterprises in the whole process of R&D, declaration and production, and provide reliable support for the compliance of product quality.