250 Generic Drugs Pass Consistency Evaluation in July with 18 First-to-File Approvals; Qilu Pharmaceutical Dominates, Biotec Pharma Follows Closely
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
According to the statistics from the Pharma Intelligence Cloud database, in July, the CDE accepted a total of500 itemsNew Registration Classification for Generic Drug Submission and Acceptance NumbersArticle 68Supplementary Application for Consistency Evaluation, Involving Pharmaceutical EnterprisesOver 380In terms of the number of declared varieties, Zhejiang Deepsea Pharmaceutical still ranks first, with 18 varieties declared this month, followed closely by Sichuan Kelun Pharmaceutical, which declared 10 varieties.
July: A Total of 250 Varieties(420 Specifications)Passed/Deemed to have passed the consistency evaluation, involving 249 pharmaceutical companies. From the perspective of enterprises, Qilu Pharmaceutical Co., Ltd.(Including subsidiaries)A bumper harvest, with 9 varieties passing evaluation,PositionTops the list。
Zhejiang pharmaceutical companies top the list this month, followed closely by Kelun Pharmaceutical.
In July, the CDE handled a total of500 itemsNew Registration Classification for Generic Drug Submission and Acceptance NumbersArticle 68Supplementary Application for Consistency Evaluation, Involving Pharmaceutical EnterprisesMore than 380. The field with the most concentrated number of declared varieties this month isDigestive System and Metabolic Drugs, followed byCardiovascular System Drugs。
Compared to the previous month, in July, companies applied for Zhejiang Deep Sea Pharmaceuticals.Continuing to exert efforts, Qilu Pharmaceutical tops the list with 18 product applications. Sichuan Kelun Pharmaceutical follows closely behind., declaring 10 varieties.
July Zhejiang Deep Sea Pharmaceutical (including subsidiaries) Declaration Variety Data
Source: PharmaCloud China Drug Evaluation Database
From the perspective of the accepted varieties, JulyVitamin B6 InjectionThe largest number of drug varieties declared by pharmaceutical companies,Up to 14Pharmaceutical companies; followed closely byBrexpiprazole Tablets, Reporting EnterpriseUp to 12, followed byNicardipine Hydrochloride Injection`, Declaration Enterprise`Up to 9 companies。
18 First Generic Approvals Granted! Qilu Pharmaceutical Tops the July Rankings
There are 250 varieties in July.(420 Specifications)Passed/Deemed to have passed the consistency evaluation, involving 249 pharmaceutical companies. From the perspective of enterprises, Qilu Pharmaceutical Co., Ltd.(Including Subsidiaries)A bumper harvest, with 9 varieties passing the evaluation, ranking first.
July Qilu Pharmaceutical (including subsidiaries) passed the review of variety data
Following closely behind is Bet Pharmaceutical.(Including Subsidiaries), ushering inSodium Betamethasone Phosphate Injection, Roxadustat Capsules, Nimodipine Oral Solution, Rebamipide TabletsEight varieties passed the evaluation, ranking second.
July Data on Approved Varieties of Bet Pharmaceutical (Including Subsidiaries)
From the perspective of approved varieties,Diquafosol Sodium Eye DropsThe number of companies passing the review is the highest, reaching six. The second isOseltamivir Phosphate Capsules, Mecobalamin TabletsBoth varieties have been approved by five pharmaceutical companies.
In terms of the first batch of approved varieties, a total of 38 varieties welcomed their first approval this month, with tablets accounting for the highest proportion, followed by injections, involving multiple pharmaceutical companies such as Qilu Pharmaceutical, Shijiazhuang Fourth Pharmaceutical, Renhe Yikang, and Chongqing Yaoyou Pharmaceutical.
First Product to Pass Review in July (The one in red is the first generic)
Source:PharmCube Approved Drugs Summary Database
July sees a surge in first generics, with 18 varieties receiving their first China-produced generic versions, including Ailamod Tablets, Sodium Phenylacetate and Sodium Benzoate Injection Concentrate, Brivaracetam Tablets, Multiple Trace Elements Injection (III), Irbesartan Amlodipine Tablets (I), Irbesartan Amlodipine Tablets (III), Entriclibupron Tablets, etc. From 2024 to date, Qilu Pharmaceutical Co., Ltd. has successfully obtained...Eltrombopag Ethanolamine Tablets, Bendamustine Hydrochloride Injection Concentrate, Tafamidis Meglumine Soft Capsules, Metformin Empagliflozin Tablets (VI), Entrectinib Pyrrolopyridine TabletsFive First-to-Market Generic Drugs Lead the TOP10 Pharmaceutical Companies.
Details of the Ranking of Pharmaceutical Companies with First Generic Approvals in China in the First Half of 2024?：First Generic in H1 2024! 44 First Generics Approved, Qilu Pharmaceutical and Wuhu Daorun Take the Lead, China Resources Tianqing...
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