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Shi Si Pharmaceutical Group’s new active pharmaceutical ingredient, dexmedetomidine hydrochloride, has been approved.
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Time:2021-09-23
Recently, the new active pharmaceutical ingredient—dexmedetomidine hydrochloride—developed and submitted by Hebei Guolong Pharmaceutical Co., Ltd. of Shisi Pharmaceutical Group has passed the technical review by the Drug Review Center of the National Medical Products Administration and has been approved for use in marketed dosage forms.
The dexmedetomidine hydrochloride injection (2 ml: 0.2 mg), which was submitted by Shiyao Group as a Class 3 chemical drug, has also received the drug production registration approval from the National Medical Products Administration and is deemed to have passed the consistency evaluation. This “active ingredient + formulation” product strategy will enhance the market competitiveness of this product.
It is reported that dexmedetomidine is an α2-adrenergic receptor agonist primarily used for sedation during endotracheal intubation and mechanical ventilation in surgical patients undergoing general anesthesia.
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