November CDE: 5 new class 1 drugs declared on the market, Zhengda Tianqing, Yangzijiang, Chengdu Yuandong Biological ... Four first imitations were approved

November CDE to undertake a total of 897 drug registration applications 8 varieties for the first time have enterprise declaration consistency evaluation 5 class 1 new drugs declared listed Karelli pearl single anti-new adaptive disease listing application 7 varieties for the first imitation declaration Beda Pharmaceuticals Class 1 new drug ensatini capsules approved 4 first imitation varieties approved CDE overall contractor situation According to MED China Drug Review Database 2.0 statistics, in November 2020 CDE to undertake a total of 897 drug registration applications.
in November 2020, the CDE to undertake drug registration applications (by the number of acceptance) consistent evaluation of supplementary applications in November, 46 varieties of consistent evaluation of supplementary applications by CDE contractor.
Among them, there are 23 oral preparation varieties, 22 injection varieties, grequinone tablets (Beijing Wanhui Shuanghe Pharmaceuticals), tweezers potassium sodium acid particles (Wuhan Vio Pharmaceuticals), amber iron tablets (Hunan Jiuyu Pharmaceuticals), Reberazole sodium intestinal tablets (Chengdu Dikang Pharmaceuticals), gluconic acid Eight varieties, such as calcium injection (Yangzhou Zhongbao Pharmaceuticals), hydroxyethyl starch 130/0.4 electrolyte injections (Hunan Colum Pharmaceuticals), hydrochloric acid terrophate injections (Lunanbet Pharmaceuticals), heavy oxycodone injections (Tianjin Jinyao Pharmaceuticals), etc., are the first consistent evaluation supplementary applications.
details can be found in the table below: November 2020 CDE supplementary application (consistency evaluation) variety of new drug applications in November, 67 varieties of new drug applications by CDE contractor, belonging to the category 1 of new drugs 51;
Nanjing St. and Pharmaceuticals submitted a new class C drug and Lebwe tablets to market applications, Keystone Pharmaceuticals submitted pD-L1 single anti-Shugli single anti-injection application, Suzhou Shengdia Bio submitted an application for the listing of injectable Karelli pearl mono-anti-new anti-adhesives, see for details Table below: November 2020 domestic new drug market application to undertake the situation in November 2020 domestic clinical application for new drugs to undertake the situation of imitation application to undertake the situation in November, 50 varieties of imitation applications by CDE contractor, of which according to 3 categories of declaration of 1 7, 33 declared by category 4; bemethylphur lore eye drops (Mega (Guangzhou) ophthalmology drugs), Tiraros tablets (Jiangsu Hausen Pharmaceutical Group), dimatrophosol right amphetamine capsules (National Pharmaceutical Group Guorui Pharmaceuticals), chlorpyb 7 varieties, such as The Tablet (Yichang People's Fu Pharmaceuticals), Brommonidine Lore Eye Drops (Zilu Pharmaceuticals), Diphthalate Hydrochloric Solutions (Xinjiang Tefeng Pharmaceuticals), Acetylamide Slow Release Capsules (Henan Zhong Shuai Pharmaceuticals), etc., were the first to apply for imitation.
details can be found in the table below: In November 2020, 42 varieties of import applications were approved by CDE, including 16 new drugs in category 1;
details can be found in the table below: November 2020 import listing application contractor situation November 2020 import clinical application approval situation According to MED China Drug Review Database 2.0 statistics, in November, 2 new drugs were approved for listing: Bay Da Pharmaceuticals (Nsatini hydrochloride), Jiangsu Haussen Pharmaceutical Group (O nitrogen flat oral instant film); 50 generic drugs approved (Class 3, Class 4, Class 5.2), of which Pomadome capsules (Zhengda Tianqing Pharmaceutical Group), 4 varieties, such as Entikave oral solution (Yangzijiang Pharmaceutical Group Jiangsu Pharmaceuticals), Lacosaamine injection (Jiangxi Qingfeng Pharmaceuticals), hydrochloric acid Meigang slow release capsule (Chengdu Yuandong Biopharmaceuticals), etc., are the first generics; Data on the approval of some varieties in January sources: MED Drug Review Database 2.0, CDE, NMPA; If there is a omission, welcome to point the right finger.
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