Shisi Pharmaceutical Group’s New API Product, Dexmedetomidine Hydrochloride, Approved


TIME:2021-09-23

【SUMMARY】 Recently, the new active pharmaceutical ingredient—dexmedetomidine hydrochloride—developed and submitted for approval by Hebei Guolong Pharmaceutical Co., Ltd. of Shisiyao Group has successfully passed the technical review by the Center for Drug Evaluation of the National Medical Products Administration and has been approved for use in marketed dosage forms.

Recently, the new active pharmaceutical ingredient—dexmedetomidine hydrochloride—developed and submitted for approval by Hebei Guolong Pharmaceutical Co., Ltd. of Shisiyao Group has successfully passed the technical review by the Center for Drug Evaluation of the National Medical Products Administration and has been approved for use in marketed dosage forms.

Shisi Pharmaceutical Group’s dexmedetomidine hydrochloride injection (2 mL: 0.2 mg), submitted as a Class 3 chemical drug, has also received 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 the product.

According to reports, dexmedetomidine is an α2-adrenergic receptor agonist primarily used for sedation during endotracheal intubation and mechanical ventilation in patients undergoing general anesthesia.

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