260 Generic Drugs Pass Consistency Evaluation in April; Seven First-to-File Generics Approved – Shijiazhuang Siyao and Qilu Pharmaceutical Emerge as Top Winners
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
According to the PharmaCloud database, in April, the CDE accepted a total of 360 new generic drug registration applications and 51 supplementary applications for consistency evaluations, involving over 320 pharmaceutical companies.In terms of the number of declared varieties, Zhejiang Saimo Pharmaceutical tops the list with 9 varieties declared this month, followed by Shijiazhuang No.4 Pharmaceutical Co., Ltd., which declared 6 varieties.
In terms of passing the review, there were 260 varieties in April.(340 Specifications)Passed/Deemed to have passed the consistency evaluation, compared to March(140 Varieties)An increase of 85.7% over the previous period, involving 224 pharmaceutical companies.Among whichShijiazhuang No.4 PharmaceuticalAndQilu Pharmaceutical(including its subsidiaries)Becoming the biggest winner this month, with 4 varieties passing the evaluation, topping the list.
Zhejiang Saimo Leads the Declaration, Shijiazhuang No.4 Pharmaceutical Co., Ltd. Follows Closely
In April, the CDE accepted 360 new registration classifications for generic drug applications and 51 supplementary applications for consistency evaluations, involving over 320 pharmaceutical companies. This monthDeclared VarietyThe most concentrated field isDigestive System and Metabolic Drugs, followed byCardiovascular System Drugs。
Data Source: PharmaCloud China Drug Evaluation Database
Shijiazhuang No.4 Pharmaceutical and Qilu Pharmaceutical Are the Biggest Winners! 7 Major First-to-Market Generic Drugs Approved
April: 260 varieties in total(340 Specifications)Passed/Deemed to have passed the consistency evaluation, compared to March(140 varieties)An 85.7% increase from the previous period, involving 224 pharmaceutical companies.
From the perspective of enterprises, this monthShijiazhuang No.4 PharmaceuticalAndQilu Pharmaceutical(Including its subsidiaries)Becoming the biggest winner this month, with 4 varieties approved, topping the list. Following closely behind are 10 pharmaceutical companies including Zhejiang Nuode Pharmaceutical, Zhejiang Huahai Pharmaceutical, Fuan Pharmaceutical, and Chongqing Yaoyou Pharmaceutical, each having 3 varieties approved.
April Evaluation Data of Shijiazhuang No.4 Pharmaceutical Co., Ltd. and Qilu Pharmaceutical Co., Ltd. (Highlighted in red for the first approval)
Data Source:PharmCube Approved Drugs Summary Database
From the perspective of approved varieties,Terbutaline Sulfate Solution for Nebulization, Phloroglucinol InjectionThe highest number of enterprises passing the evaluation for two varieties has reached four. Next isSodium Ampicillin for Injection, Levalbuterol Hydrochloride Nebulizer Solution, Empagliflozin Tablets, Lidocaine Hydrochloride Injection, Tadalafil Tablets, Linezolid Glucose InjectionAll 14 varieties have been approved by three pharmaceutical companies.
In terms of the first batch of approved varieties, a total of 19 varieties have received their first approval this month, involvingGuangzhou Yipinhong Pharmaceutical, Qilu Pharmaceutical, Shijiazhuang No.4 Pharmaceutical Co., Ltd., Nanjing Zhengke PharmaceuticalAnd many other pharmaceutical companies. Among themOxcarbazepine Oral Suspension, Bisoprolol Amlodipine Tablets, Sodium Acetate Ringer's Glucose Injection, Metformin Empagliflozin Tablets (Ⅲ), Letermovir Tablets, Rivaroxaban Granules, Linezolid for SuspensionSeven varieties welcome their first generics.
First approved variety in April (The first generic is marked in red)
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