Great news! Shijiazhuang No.4 Pharmaceutical’s Dexmedetomidine Hydrochloride Injection (1 ml: 0.1 mg) has been approved.
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Time:2022-02-25
On February 9, the company’s Class 3 chemical drug, Dexmedetomidine Hydrochloride Injection (1 ml: 0.1 mg), received a drug registration certificate issued by the National Medical Products Administration and is deemed to have passed the evaluation of bioequivalence and therapeutic equivalence for generic drugs.
Just after the Spring Festival holiday, Shijiazhuang No.4 Pharmaceutical Co., Ltd. has once again delivered good news in its research and development efforts. On February 9, the company’s Class 3 chemical drug—Dexmedetomidine Hydrochloride Injection (1 ml: 0.1 mg)—received a drug registration certificate issued by the National Medical Products Administration, and is deemed to have passed the evaluation of bioequivalence and therapeutic equivalence for generic drugs.
It is reported that dexmedetomidine hydrochloride is an α2-adrenergic receptor agonist, primarily used for sedation during endotracheal intubation and mechanical ventilation in surgical patients undergoing general anesthesia, as well as for sedation in critically ill patients who have undergone intubation and are on ventilators during intensive care treatment. Dexmedetomidine hydrochloride injection is listed in the National Medical Insurance Catalogue.
Previously, the 2ml:0.2mg specification of dexmedetomidine hydrochloride injection developed by Shijiazhuang No.4 Pharmaceutical and the raw material dexmedetomidine hydrochloride developed by Hebei Guolong Pharmaceutical Co., Ltd. of Shijiazhuang No.4 Pharmaceutical Group were successively approved in 2021. The recent approval of dexmedetomidine hydrochloride injection (1ml:0.1mg) will play a positive role in further enriching and perfecting the product portfolio of this drug, enhancing its market competitiveness, and accelerating the implementation of Shijiazhuang No.4 Pharmaceutical Group’s “raw material + finished dosage form” strategy.
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