Another batch of drugs will pass the consistency evaluation

Another batch of drugs will pass the consistency evaluation A batch of drugs have been evaluated on the way This month, tailing pharmaceutical announced that the consistency evaluation of quetiapine fumarate tablets (Shusi) developed and produced by its subsidiary Suzhou No.1 Pharmaceutical Co., Ltd involved in drug development, production transfer, clinical bioequivalence, etc has been completed The relevant registration information has also been submitted to the State Drug Administration on October 31, 2018, and is expected to pass the review by the end of the first quarter of 2019 At the same time, Jingxin pharmaceutical said in the latest investigation that amlodipine besylate and cefuroxime axetil tablets are under review, simvastatin has been declared, and other product development and reporting will follow In addition, Qianhong pharmaceutical has submitted an application for the consistency evaluation of enoxaparin sodium, which is expected to enter the review sequence this month (November) This is also the second application for consistency evaluation of enoxaparin sodium submitted in China after Shenzhen Tiandao medicine Last month, according to the statistics of the past evaluation of 10 drugs, there are 105 drugs that have passed the consistency evaluation (see the annex for details) The following figure shows the past evaluation in October: Note: the donepezil hydrochloride tablets of Zhejiang Huahai are approved and listed according to the new registration classification, and are deemed to have passed the consistency evaluation (data source: drug screening) according to the registration and acceptance data of drug intelligence, by the end of October, CDE had undertaken 491 acceptance numbers of consistency evaluation, involving 184 varieties of 186 enterprises, including 232 acceptance numbers of 289 catalogue drugs, involving 69 varieties, and the startup rate of 289 catalogue drugs was 23.88% In addition, at present, 75 (41 varieties) have passed the consistency evaluation acceptance number, of which 19 are in 289 catalogue, with a completion rate of only 6.57% A wave of pharmaceutical companies have applied recently, and many of them have applied for conformity assessment According to data of yaozhi.com, on October 30, the conformity assessment of cefradine capsule of Shandong Xinhua Pharmaceutical was undertaken by CDE On October 30, the consistency evaluation of cefuroxime ester tablets of Shantou Jinshi Pharmaceutical Co., Ltd of Sinopharm group was undertaken by CDE On October 29, the consistency evaluation of Jiangsu Yuexing metronidazole tablets was undertaken by CDE On October 29, the consistency evaluation of amlodipine besylate tablets of Yichang dongyangtse Pharmaceutical Co., Ltd was undertaken by CDE On October 29, the consistency evaluation of edaravone injection of Nanjing Xiansheng Dongyuan pharmaceutical was undertaken by CDE On October 26, the consistency evaluation of bisoprolol fumarate tablets of Beijing HuaSu pharmaceutical was undertaken by CDE On October 26, the consistency evaluation of metformin hydrochloride sustained-release tablets of Guangdong Saikang pharmaceutical was undertaken by CDE On October 25, two more acceptance numbers of Shanghai sanuo biomedical yifeiwelun tablets were undertaken by CDE On October 25, the consistency evaluation of Chongqing Kerui pharmaceutical metformin hydrochloride tablets was undertaken by CDE Appendix: summary of drugs that have passed the consistency evaluation