Shanghai Pharmaceuticals Holding (02607): The ANDA for Tigrisil tablets was approved by the US FDA.
Shanghai Pharmaceuticals (02607) announced that recently, its subsidiary Changzhou Pharmaceutical Factory Co., Ltd. (hereinafter referred to as "Changzhou Pharmaceutical Factory...
Shanghai Pharmaceuticals Holding (02607) announced that its subsidiary Changzhou Pharmaceutical Factory Co., Ltd. has received a notification from the US Food and Drug Administration (FDA) that its Abbreviated New Drug Application (ANDA) for ticagrelor tablets has been granted Final Approval.
Ticagrelor is used for patients with acute coronary syndrome, including those undergoing drug therapy and percutaneous coronary intervention, to reduce the rate of thrombotic cardiovascular events. Developed by AstraZeneca, it was launched in the US in 2011. In May 2021, Changzhou Pharmaceutical Factory submitted an ANDA application to the US FDA for this drug and recently received Final Approval. As of the date of this announcement, the company has invested approximately RMB 9.6713 million in research and development for this drug.
The approval of Changzhou Pharmaceutical Factory's ANDA for ticagrelor by the US FDA is of great significance for the company to further expand its overseas market and accumulate valuable experience.
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