Dronedarone

Atrial fibrillation is one of the most common persistent arrhythmias in clinical practice. Amiodarone, a traditional antiarrhythmic drug, has an iodine-containing structure, so long-term use of it is prone to induce multi-organ toxicity such as thyroid and lung toxicity, which has long restricted the choice of long-term clinical medication. Dronedarone is a benzofuran derivative antiarrhythmic drug. Through deiodination modification of amiodarone's structure while retaining the multi-ion channel blocking effect, it can inhibit sodium, potassium and calcium ion channels and antagonize α and β adrenergic receptors. While maintaining sinus rhythm and slowing ventricular rate, it greatly reduces the risk of iodine-related organ toxicity. It is mainly used clinically for rhythm control in patients with paroxysmal or persistent atrial fibrillation and atrial flutter to reduce the risk of cardiovascular hospitalization, and is especially suitable for patients with medium and low risk atrial fibrillation complicated with underlying cardiovascular diseases.

The global market size of dronedarone was approximately USD 480 million in 2023. In recent years, with the continuous rise in the prevalence of atrial fibrillation and the increasing clinical demand for long-term medication safety, the annual compound growth rate of the market has remained at around 6.2%. In terms of the domestic market, this variety has not yet been included in the national centralized procurement, and the original research product still occupies the main market share. Domestic generic drugs have been successively approved for marketing since 2021, and the space for domestic substitution is gradually released. Restricted by the multiple synthesis steps of the compound and the high difficulty of quality control, the number of domestic enterprises with large-scale API production capacity is relatively small at present, and the upstream supply pattern is relatively concentrated.

The original research enterprise of dronedarone is Sanofi, and the original research trade name is "Multaq". The expiration time of its core compound patent in the United States is 2021, and the expiration time of the core compound patent in China is 2022. The mainstream dosage form of the original research is tablet with a specification of 400mg, which has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also a reference preparation announced by the FDA. Up to now, China NMPA has approved a number of domestic dronedarone preparations for marketing, and multiple enterprises have submitted registration of dronedarone APIs on the CDE API registration platform, with some registrations in status A, which can be used in association with domestic preparation declarations. (Data as of April 2025, please refer to the official CDE website for the latest information)

In response to the impurity research needs in the R&D and production links of dronedarone, CATO can provide a full set of impurity reference standards for this API. Most of the products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully support the full-process needs of API quality research, preparation stability investigation and declaration and registration.