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According to the PharmaCloud database, in June, the CDE accepted a total of 355 new registration classification generic drug applications and 35 consistency evaluation supplementary applications, involving over 300 pharmaceutical companies. In terms of the number of declared varieties, Zhejiang Saimo Pharmaceutical ranked first with 17 varieties declared this month, followed by Nanjing Haina Pharmaceutical, which declared 6 varieties.
There are 249 varieties in June.(444 Specifications)Passed/Deemed to have passed the consistency evaluation, involving 253 pharmaceutical companies. From the perspective of enterprises, BRILLIANT PHARMACEUTICALS this month...(Including its subsidiaries)A bumper harvest, with 7 varieties approved, ranking at the top.
Zhejiang Saimo Submits the Most, Haina Pharmaceutical Follows Closely
In June, CDE handled a total of355New Registration Classification for Generic Drug Submission and Acceptance Numbers35Supplementary Application for Consistency Evaluation, Involving Pharmaceutical EnterprisesOver 300Home. The field with the most concentrated number of declared varieties this month isDigestive System and Metabolic Drugs, followed bySystemic Anti-Infective Drugs。

June Zhejiang SaimoDeclaration of Variety Data
Source: PharmaCloud China Drug Evaluation Database

BRILLIANT PHARMACEUTICALS Harvests Big, Leads the Approval Rankings This Month
JuneTop 2 pharmaceutical companiesPassed the reviewProduct Data (Marked in Red for the First)
Source: PharmaKoo Generic Drugs Summary Database
From the perspective of the approved varieties,Peramivir InjectionThe number of companies that passed the review is the highest, reaching 9. Secondly,Sitagliptin Phosphate Tablets, Pentoxifylline Injection, Phloroglucinol InjectionAll three varieties have been approved by five pharmaceutical companies.
In terms of the first batch of approved varieties, a total of 35 varieties have received their first approval this month. Tablets and injections account for the highest proportion, involving multiple pharmaceutical companies such as Qilu Pharmaceutical, Chongqing Shenghuaxi Pharmaceutical, Jichuan Pharmaceutical, and Joincare Pharmaceutical.
June's First Approved Variety (The one in red is the first generic)
Source:PharmCubeSummary of Approved DrugsDatabase
June sees a surge in first generics, with 18 varieties welcoming their first generic versions in China, includingDeferasirox Granules, Low Calcium Peritoneal Dialysis Solution (Bicarbonate-G2.5%), Calcitriol Injection, Progesterone Injection (II), Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules, Tafamidis Methylglucamine Soft Capsules, Clevidipine Injectable Emulsion, Rebamipide Capsules, Salmeterol Xinafoate and Fluticasone Propionate Inhalation Powderetc.

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