94 Generic Drugs Pass Consistency Evaluation in November; 4 First-to-File Generics Approved – Qilu Pharma Emerges as Top Performer, with Shandong Qidu, Shijiazhuang No.4 Pharma Also Notable
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
Shijiazhuang No.4 Pharmaceutical Co.,Ltd.
Manufacturers and Service Providers of Chemical Drugs and Traditional Chinese Medicine
According to the statistics from the PharmCube database, during November, the CDE handled 378 new registration classification generic drug application dossiers and 97 consistency evaluation supplementary applications, involving over three hundred pharmaceutical companies. Among them,Zhejiang Saimo PharmaceuticalShijiazhuang No.4 Pharmaceutical Co.,Ltd. ranked first with 14 applications. Zhejiang Huahai Pharmaceutical, Nanjing Haina Pharmaceutical, and Kelun Pharmaceutical followed closely, each submitting seven or more generic applications.
Compared with October, the number of approvals this month has declined. However,Qilu PharmaceuticalStill performed outstandingly, becoming the biggest winner of the month with 3 approved varieties. Shandong Qidu Pharmaceutical Co., Ltd., Wuxi Kaifu Pharmaceutical Co., Ltd., Shijiazhuang No.4 Pharmaceutical Co., Ltd., Jiangsu Aosaikang Pharmaceutical Co., Ltd., and Chongqing Lummy Pharmaceutical Co., Ltd. followed closely, each obtaining approval for 2 varieties.
Over 300 Companies Involved in the Declaration, Zhejiang Saimo Pharmaceutical Still Ranks First
In November, the CDE accepted 378 new registration classification generic drug applications and 97 consistency evaluation supplementary applications, involving over 300 pharmaceutical companies.The field with the highest concentration of declared varieties is the digestive system and metabolic drugs, followed by cardiovascular system drugs and systemic anti-infective drugs.
Screenshot source: PharmaOcean China Drug Evaluation Database - Global Analysis
Compared to the previous monthEnterprise Declaration Status,Zhejiang Saimo PharmaceuticalStill firmly in the top position,Zhejiang Huahai Pharmaceutical Co., Ltd. andNanjing Haina PharmaceuticalFollowing closely, ranking second and third.Among whichZhejiang Saimo Pharmaceutical Co., Ltd., has submitted a total of14Generic Market Entry Application，Among them,4PaymentGastrointestinal and Metabolic Drugs, 3 Sensory System Medications, 3 Dermatological Medications, 2 Respiratory System Medications andCardiovascular System Medications. Secondly,Zhejiang Huahai Pharmaceutical Co., Ltd.Nanjing Haina Pharmaceutical、Kelon PharmaceuticalPharmaceutical companies such as Shijiazhuang No.4 Pharmaceutical Co.,Ltd., Jiangsu Aosaikang Pharmaceutical Co.,Ltd., Qilu Pharmaceutical Co., Ltd., Wuxi Kaifu Pharmaceutical Co.,Ltd., and Shandong Qidu Pharmaceutical Co., Ltd. have all submitted applications.7One or more generic applications.
Zhejiang Saite Pharmaceutical November Filing Status
Screenshot source: PharmaCloud China Drug Evaluation Database - Global Analysis
From the perspective of the types of products accepted,Potassium Chloride Granules, Sodium Bicarbonate Injection, Famotidine Injection, Norepinephrine Bitartrate Injection, Minoxidil Lotion, Potassium Chloride InjectionThe number of related enterprises of varieties is the largest.
Screenshot source: PharmaCloud China Drug Evaluation Database - Global Analysis
13 Major Varieties Achieve First Evaluation Success, 4 First Generic Approvals Granted
In November, there were a total of 94 varieties.(152 specifications)Passed/Deemed to have passed the consistency evaluation, involving nearly a hundred enterprises. Compared to October(205 varieties)A 54% month-on-month decrease, involving 104 enterprises.
Despite the decline in the number of approvals in November,Qilu PharmaceuticalStill became the biggest winner of the month, with 3 approved varieties, followed byShandong Qidu Pharmaceutical Co., Ltd., Wuxi Kaifu Pharmaceutical Co.,Ltd., Shijiazhuang No.4 Pharmaceutical Co.,Ltd., Jiangsu Aosaikang Pharmaceutical Co.,Ltd., Chongqing Lai Mei PharmaceuticalBoth have obtained approval for 2 varieties.
Data Source:PharmCube Approved Drug Summary Database
In terms of varieties,Cefoperazone Sodium and Sulbactam Sodium for Injection, Dapoxetine Hydrochloride Tablets, Alprazolam TabletsThe highest number of companies passed the review, reaching 3, among whichBudesonide Nasal Spray, InjectablePiperacillin Sodium and TazobactamTannan, Eldecalcitol Soft Capsules, Cefprozil TabletsAll 10 varieties have been approved for production by two enterprises.
In terms of the first approved variety, there are a total of13First Variety Passes Evaluation, InvolvingSichuan PureTech Pharmaceutical, Nanchang BeiGene Pharmaceutical、Jiangsu Hengrui Pharmaceutical、Shanghai Jincheng Suzhi Pharmaceutical Co., Ltd.、Jiangsu Kangyuan PharmaceuticalAnd many other pharmaceutical companies. Among themCrizotinib Capsules, Budesonide Nasal Spray, Amoxicillin Sodium Clavulanate Potassium for Injection (Ⅱ), Perampanel Tablets4The first generic versions of these varieties have arrived. See the table below for details.
November's First Approved Variety (Red for the First Generic)
Data Source:PharmCubeSummary of Approved DrugsDatabase
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