In April, a total of 109 acceptance numbers passed/deemed to pass the consistency evaluation, involving 65 varieties of 69 companies, of which 8 varieties are 289 catalog products, and 15 varieties are the first to pass the evaluation. In terms of over-assessment companies, Qilu Pharmaceutical was a big winner in April, with 7 approvals and 5 varieties passing the consistency evaluation. Qilu Pharmaceutical is a large-scale comprehensive modern pharmaceutical company in China, specializing in the development, production and sales of preparations for the treatment of tumors, cardiovascular, cerebrovascular, anti-infection, mental system, nervous system, and ophthalmological diseases and their raw materials. The company has 331 approval documents in China's listed drug database, involving 208 varieties. The company has currently declared/deemedly declared 96 varieties, and 52 varieties have been evaluated, including tenofovir disoproxil fumarate tablets, ceftriaxone sodium for injection, and bivalrudine for injection. Followed by Huahai, Guangshengtang, Chia Tai Tianqing, and Hengrui all have 3 varieties reviewed.
In terms of varieties, the most intensely competitive varieties in April were rivaroxaban tablets and amoxicillin capsules, both of which were reviewed by five companies. In addition, 5 varieties including Moxifloxacin Hydrochloride Eye Drops have been reviewed by 3 companies. Up to now, a total of 40 companies in Rivaroxaban have applied for consistency evaluation, and 17 companies have passed the evaluation. Rivaroxaban tablets, a new type of anticoagulant, used in adult patients with elective hip or knee replacement surgery to prevent venous thrombosis (VTE); used to treat adult deep vein thrombosis (DVT) and pulmonary embolism (PE) ; Used to reduce the risk of DVT and/or PE recurrence in patients with persistent risk of recurrence of DVT and/or PE after completing at least 6 months of initial treatment; used in non-valvular rooms with one or more risk factors In adult patients, to reduce the risk of stroke and systemic embolism; under well-controlled conditions with warfarin, compared with warfarin, there are limited data on the relative effectiveness of rivaroxaban in reducing the risk of stroke and systemic embolism. Amoxicillin Capsules currently has 68 companies that have applied for consistency evaluation, of which 32 companies have been evaluated. Amoxicillin is suitable for the following infections of adults and children caused by sensitive bacteria (strains that do not produce β-lactamase), and should refer to the official guidelines for clinical application of antibacterial drugs when using it.
Attached Table 1: Details of the consistency evaluation passed (including deemed passed) in April 2021
Data source: Yaozhi Data Generic Drug Consistency Evaluation and Analysis System
Attached Table 2: Details of the consistency evaluation of the declaration in April 2021
December 13, 2022
December 06, 2022
November 16, 2022
November 16, 2022
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December 13, 2022
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