Lianhuan pharmaceutical withdraws the application for production of two new drugs
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Last Update: 2015-12-07
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Source: Internet
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Author: User
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Lianhuan Pharmaceutical (600513) announced on December 6 that the company had withdrawn the application submitted for production of compound felodipine sustained release tablets and yidiplune oxalate tablets from the drug registry of Jiangsu food and drug administration According to Lianhuan pharmaceutical, based on the current situation of clinical trials in China and the suggestions of the above clinical trial institutions and contract research organizations, the company has voluntarily withdrawn the application for production of compound felodipine sustained release tablets and yidiprolen oxalate tablets The company will, in accordance with the relevant provisions of the announcement of the State Food and Drug Administration on several policies for drug registration review and approval (No 230, 2015), re apply for the production of compound felodipine sustained release tablets and yidiprolen oxalate tablets after completing the relevant research According to the announcement, the main indication of compound felodipine sustained-release tablets is hypertension, and the new drug company has invested about 2.6 million yuan in research and development at this stage The main indication of yidipulon oxalate tablets is depression The R & D cost of the new drug is invested by Jiangsu aosaikang Pharmaceutical Co., Ltd and Nanjing haiguang Applied Chemistry Research Institute Co., Ltd and the R & D cost is about 2.2 million yuan According to the announcement, the withdrawal of the company's production application for compound felodipine sustained release tablets and edeplan oxalate tablets will not have a significant impact on the company's current and future operations.
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