205 Generic Drug Variants Pass Evaluation, 10 First-in-Class Generics Approved: Qilu and Kelun Lead Market Surge
Shijiazhuang No.4 Pharmaceutical Co.,Ltd.
Manufacturers and Service Providers of Chemical Drugs and Traditional Chinese Medicine
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
CHIATAI TIANQING
High-quality pharmaceuticals research, production, and sales provider
CSPC
Innovative Drug Research and Development, Manufacturer
According to the Pharma Data Cloud database, during October, the CDE accepted a total of 342 new registration classification generic drug applications and 61 consistency evaluation supplementary applications, involving nearly 300 pharmaceutical companies.
Among them,Zhejiang Saimo PharmaceuticalStanding out and demonstrating strong competitiveness, they applied for 12 varieties. Following closely behind isTianjin Jinyao PharmaceuticalAndShijiazhuang No.4 Pharmaceutical Co.,Ltd.、Zhejiang Gaozhi Pharmaceutical, all of which have submitted five or more generic applications. The highly anticipatedQilu Pharmaceutical, CHIATAI TIANQING, JIUDIAN PHARMACEUTICALAndCSPCCompanies such as Shijiazhuang No.4 Pharmaceutical Co.,Ltd., JIUDIAN PHARMACEUTICAL, CSPC, Qilu Pharmaceutical Co., Ltd., and Chia Tai Tianqing Pharmaceutical Group Co., Ltd. have all submitted three or more generic drug marketing applications. The competition for generic drugs this month has been exceptionally fierce, with major companies striving to seize the market opportunity.
In terms of evaluation, the number of evaluated varieties increased this month. A total of 205 varieties were evaluated in October.(407 Specifications)Passed the review(Up 63% over last month)。Among them,Qilu PharmaceuticalNumber of approvals: 10,KELUN PHARMACEUTICALAlso shone brightly, with 9 products passing the evaluation, and two companies reaping rich rewards.Secondly,Shijiazhuang No.4 Pharmaceutical Co.,Ltd.AlsoPerformed excellently, successfully obtained8A number of drugs have passed the evaluation,Qingdao RuiNai、Chengdu Better and Jiangsu WangoAll have successfully passed the evaluation for four or more varieties.
Status of Consistency Evaluation Submission
During October, the CDE accepted a total of 342 new registration classification generic drug applications and 61 consistency evaluation supplementary applications, involving nearly 300 pharmaceutical companies. The most concentrated field for the declared varieties isCardiovascular System MedicationsField, followed byDigestive System and Metabolism Drugs。
From the application status of various enterprises,Zhejiang Saite PharmaceuticalThe largest number of applications were submitted, with a total of 12 generic drug marketing applications, five of which are...Respiratory and Sensory System Medications。Secondly isTianjin Jinyao Pharmaceutical、Shijiazhuang No.4 Pharmaceutical Co.,Ltd.、Nanjing Haina PharmaceuticalSubmitted 5 or more generic applications.
Data Source: PharmaOcean China Drug Evaluation Database
From the perspective of the accepted varieties,Minoxidil Topical Solution, Diprophylline Injection, Oseltamivir Phosphate for Oral Suspension, Diquafosol Sodium Eye Drops, Famotidine Injection, Cefazolin Sodium for InjectionThe number of related enterprises of various varieties is the largest.
Screenshot source: PharmaCloudChina Drug EvaluationAccording to the database- Global Analysis
Newly Approved Status in October
There are 205 varieties in October.(407 Specifications)Passed the review(Up 63% over the previous period). Among them,Qilu PharmaceuticalNumber of approvals: 10KELUN PHARMACEUTICALAlso shone brightly, with 9 products passing the evaluation, and two companies reaping rich rewards.
Secondly,Shijiazhuang No.4 Pharmaceutical Co.,Ltd.AlsoPerformed excellently, successfully obtained8A number of drugs have passed the evaluation,Qingdao RuiNai、Chengdu Bright and Jiangsu WangoAll have successfully passed the evaluation for four or more varieties.
In terms of the first approved variety, there are a total of24 Varieties Welcome the First Approval, involvingNanjing Zeheng Pharmaceutical, Renhe Yikang, Qilu Pharmaceutical, Jiangsu Wanbang BiochemicalAnd many other pharmaceutical companies.
Among themOsimertinib Mesylate Tablets, Paliperidone Palmitate Injection, Loxoprofen Sodium Oral Solution, Salbutamol Sulfate Oral Solution, Fluconazole Dry Suspension, Baricitinib Tablets, Methotrexate Injection, Macitentan TabletsTen varieties, including the first generic, are listed in the table below.
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