Shanghai Pharmaceuticals Holding (601607.SH): Telmisartan tablets obtain approval number from the US FDA
Shanghai Pharmaceuticals (601607.SH) issued an announcement recently, stating that its subsidiary Changzhou Pharmaceutical Factory Co., Ltd. (referred to as "Chang...
Shanghai Pharmaceuticals Holding (601607.SH) announced that its subsidiary Changzhou Pharmaceutical Factory Co., Ltd. ("Changzhou Pharmaceutical Factory") has received notification from the U.S. Food and Drug Administration (FDA) that its Abbreviated New Drug Application (ANDA) for Ticagrelor tablets has been granted final approval for marketing.
Ticagrelor tablets are used for patients with acute coronary syndrome, including those receiving drug treatment and percutaneous coronary intervention, to reduce the incidence of thrombotic cardiovascular events. The original drug was developed by AstraZeneca and was introduced in the U.S. in 2011. In May 2021, Changzhou Pharmaceutical Factory submitted the ANDA application for this drug to the U.S. FDA and recently received final approval for marketing. As of the date of this announcement, the company has invested approximately RMB 9.67 million in research and development expenses for this drug.
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