Progress & Summary: The pass rate of consistency evaluation 289 is only 7.96%; the latest three companies have passed the evaluation, Shanghai Pharmaceutical, Yuekang Pharmaceutical, Shandong Hongjitang...

As of December 25, a total of 133 products have passed (or deemed to have passed) conformity assessment, involving 66 varieties, of which 47 products have passed 289 catalogue, involving 23 varieties, with a completion rate of only 7.96% Recently, two varieties of metformin hydrochloride sustained-release tablets from Shanghai Xinyi Pharmaceutical Co., Ltd and yuekang Pharmaceutical Co., Ltd and montmorillonite powder from Shandong hongjitang Pharmaceutical Group Co., Ltd were approved (attached with a complete list, see attached Tables 1 and 2) metformin hydrochloride sustained release tablets On December 25, Shanghai Pharmaceutical Group announced that its wholly-owned subsidiary Shanghai Shangyao Xinyi Pharmaceutical Factory Co., Ltd (hereinafter referred to as "Shangyao Xinyi") had recently received the approval document for supplementary application for metformin hydrochloride sustained-release tablets (0.5g) issued by the State Drug Administration, which passed the consistency evaluation of generic drugs In addition, yuekang Pharmaceutical Co., Ltd recently announced that on December 18, the approval document issued by the State Drug Administration was received, and yuedaning ® metformin hydrochloride sustained-release tablets (0.5g) officially passed the conformity evaluation of generic drugs It is worth mentioning that yuekang Pharmaceutical Co., Ltd has not only reviewed this time, but also passed the change of formulation and process for metformin hydrochloride sustained-release tablets Approval conclusion: according to the provisions of the drug administration law of the people's Republic of China, the opinions of the State Council on the reform of the review and approval system of pharmaceutical medical devices (GF [2015] No 44) and the announcement on the issues related to the conformity evaluation of quality and efficacy of generic drugs (2017 No 100), the conformity evaluation of this product has passed the examination Metformin hydrochloride sustained-release tablets for the treatment of diabetes drugs, by Merck and Bristol Myers Squibb Co., Ltd research and development, as early as 2000 in the United States approved the listing According to the pharmaceutical intelligence data, 43 domestic enterprises currently hold the production approval documents of 0.5g metformin hydrochloride sustained-release tablets, among which 10 enterprises apply for the consistency evaluation, and Jiangsu Deyuan pharmaceutical industry is the first one that has passed the evaluation, and now there are 3 enterprises that have passed the evaluation Data source: drug intelligence drug registration and acceptance database montmorillonite powder according to drug intelligence data, recently Shandong hongjitang Pharmaceutical Group's montmorillonite powder (each bag contains 3 grams of montmorillonite) also passed the consistency evaluation At present, 29 domestic enterprises hold the production approval documents of this specification of montmorillonite powder, 12 enterprises apply for conformity evaluation, and 4 enterprises have passed the evaluation The clinical application of montmorillonite powder: 1 Acute and chronic diarrhea in adults and children 2 It is used as an assistant treatment for pain symptoms caused by diseases of esophagus, stomach and duodenum, but not as an antispasmodic Data source: registration and acceptance database of smart drugs Appendix 1: non 289 directory passing (87 product regulations, 47 varieties) Appendix 2: 289 directory passing (47 product regulations, 23 varieties) part of content information source: Shanghai Pharmaceutical announcement, yuekang pharmaceutical official micro