Puli Pharmaceutical's Amiodarone Injection, the TOPone Anti arrhythmic Product, has been approved fo

Puli Pharmaceutical's Amiodarone Injection, the TOPone Anti arrhythmic Product, has been approved for sale by the National Medical Products Administration! Puli Pharmaceutical's amiodarone injection has been approved for market by the National Medical Products Administration! Zhejiang Puli Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Hainan Puli Pharmaceutical Co., Ltd., recently received a drug registration approval for amiodarone injection issued by the National Medical Products Administration (NMPA), which is considered to have been approved for listing through consistency evaluation and will have a positive impact on expanding the domestic market. Puli Pharmaceutical's Amiodarone Injection Approval: threeml: one hundred and fiftymg, eighteenml: nine hundredmg. Puli Pharmaceutical has two approved specifications for Amiodarone Injection in China: threeml: one hundred and fiftymg, eighteenml: nine hundredmg. The company's amiodarone injection is an integrated variety of raw materials and preparations for both China and the United States, with guaranteed quality and safety. It will provide high-quality medication choices for domestic patients. Basic Information of Amiodarone Hydrochloride Amiodarone belongs to Class III antiarrhythmic drugs and is a multi ion channel blocker. Therefore, it also has the effects of Class I, II, and IV antiarrhythmic drugs. Intravenous use of amiodarone is more manifested as effects beyond Class III drugs, namely sodium channel blockade, beta receptor blockade, and calcium channel blockade. By inhibiting these ion channels, the electrophysiological effects include suppressing the autonomy of the sinoatrial node and atrioventricular junction, slowing down atrial, atrioventricular node, and atrioventricular bypass conduction, and delaying the action potential duration and effective refractory period of atrial and ventricular muscles. This leads to broad-spectrum antiarrhythmic effects and is the first-line medication for clinical antiarrhythmic treatment. Amiodarone hydrochloride was first synthesized in one thousand nine hundred and sixty-one and was found to be useful for arrhythmia in one thousand nine hundred and seventy-four. Amiodarone hydrochloride was first approved for oral use in France in December one thousand nine hundred and sixty-six and for injection in France in April one thousand nine hundred and seventy-six. In one thousand nine hundred and eighty-five, its oral formulation was launched in the United States under the trade name Cordarone, licensed by Wyeth Pharmaceuticals Inc., for the treatment of arrhythmia. Cordarone injection was launched in the United States and Canada in one thousand nine hundred and ninety-five. Cordarone injection is currently available in countries such as the United Kingdom, France, Italy, and the Netherlands. China approved the original import application for Cordargne injection on April twenty-seven, two thousand seven. After completing technical research and development, Puli Pharmaceutical gradually submitted product marketing applications to multiple domestic and international markets for amiodarone injection. In September two thousand twenty-four, it obtained FDA approval in the United States and NMPA approval in China. In addition to the approved countries mentioned above, the registration work for other markets of amiodarone injection is continuously progressing. Currently, Canada is under review, while Thailand and the Philippines are pending submission. According to IQVIA data, the global sales revenue of amiodarone hydrochloride injections in two thousand twenty-three is approximately RMB eight hundred and ninety million, with a stable growth rate in recent years. The US market holds fifty-four% of the market share, making it the largest market in the world, while the Chinese market holds seventeen% of the market share,