Qilu Pharmaceutical's Dalteparin Sodium Injection, a 700 Million RMB+ Market Product, Passes Consistency Evaluation
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
On September 4, according to the NMPA announcement,Qilu PharmaceuticalSubmittedDalteparin Sodium InjectionPassed the consistency evaluation. From 2024 to present, Qilu Pharmaceutical(Including Subsidiaries)Thirty-four varieties have passed the evaluation, eight of which are the first to pass.
Dalteparin Sodium InjectionIt is an anticoagulant used to treat acute deep vein thrombosis and unstable coronary artery diseases such as unstable angina and non-Q-wave myocardial infarction. It is also used to prevent clotting in the extracorporeal circulation system during hemodialysis and hemofiltration in patients with acute renal failure or chronic renal insufficiency, as well as thrombosis associated with surgery. According to the PharmaOcean database,Dalteparin Sodium InjectionExceeding 700 million yuan in sales revenue in the Chinese hospital market in 2023.
Currently,Dalteparin Sodium InjectionIn China, six companies have obtained production approval, including Hebei Changshan Biochemical Pharmaceutical, Nanjing Jianyou Biochemical Pharmaceutical, Changzhou Qianhong Biochemical Pharmaceutical, Yantai Dongcheng Northern Pharmaceutical, and Qilu Pharmaceutical.
In terms of generic drug layout, currently,Dalteparin Sodium InjectionChenxin Pharmaceutical has submitted a Class 4 generic application for marketing.
From 2024 to present, Qilu Pharmaceutical(Including subsidiaries)There are 34 varieties that have passed the evaluation, includingCarvedilol Tablets, Metformin Empagliflozin Tablets (VI), Cefpodoxime Proxetil Tablets, Emtricitabine Rilpivirine Tenofovir Alafenamide TabletsEight products, etc.VarietyIs the first to pass the evaluation.
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