With an annual sales volume of 1 billion yuan, pantoprazole sodium for injection of Huadong medicine has been temporarily approved by the US FDA

On April 3, East China Pharmaceutical released a notice that its wholly-owned subsidiary Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd (hereinafter referred to as "Zhongmei Huadong") has recently received a notice from the FDA of the United States for the short application for new drugs (anda) of pantoprazole sodium for injection for sterile injection Pantoprazole sodium is a new generation of proton pump inhibitor after omeprazole sodium and lansoprazole sodium Its main indications are duodenal ulcer, gastric ulcer, acute gastric mucosal lesions, complex gastric ulcer and other acute upper gastrointestinal bleeding The product was developed by BYD gulden (now a subsidiary of Takeda, Takeda, Takeda, Takeda, Japan) It was listed in Germany and Mexico in 1994, and its formulation was enteric coated tablets The injection type of the product was approved by Wyeth pharmaceutical company Wyeth (authorized by Takeda) in the United States in March 2001, under the trade name of protonix At present, the manufacturers of pantoprazole sodium for injection in the United States are only the original research company, Takeda pharmaceutical of Japan (the distributor is Wyeth pharmaceutical), and the main domestic manufacturers are Hangzhou Zhongmei Huadong pharmaceutical, Yangzijiang Pharmaceutical Group, Jiangsu aosaikang pharmaceutical, Hainan Puli pharmaceutical, etc According to the statistics of iqvia (AI kunwei: the world's leading information and R & D service company), in 2018, the global market sales of pantoprazole sodium products (including injection, tablet, capsule, etc.) was about US $3.069 billion (including injection sales of about US $1.054 billion); the total sales of the United States was about US $269 million, and the total sales of China was about US $1 billion China, the United States and East China submitted an application for anda registration in August 2016 In February 2017, they accepted the on-site inspection by the U.S FDA, and in November 2017, they were officially notified to pass the on-site inspection Up to now, the company has invested about 10 million yuan in the research and development of the international registration project of the product The following is the original announcement: