Shijiazhuang Sihua Pharmaceutical Group’s aggrastat active pharmaceutical ingredient has been approved.
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Time:2022-09-07
【概要描述】
Recently, the active pharmaceutical ingredient—aggrastat—submitted by Hebei Guangxiang Pharmaceutical Co., Ltd., a subsidiary of Shijiazhuang Fourth Pharmaceutical Group, has been approved by the National Medical Products Administration for registration as an API intended for use in marketed formulations.
Recently, Agatoban, a raw material drug submitted by Hebei Guangxiang Pharmaceutical Co., Ltd. of Shijiazhuang Fourth Pharmaceutical Group, has been approved by the National Medical Products Administration for registration as an active pharmaceutical ingredient intended for use in marketed formulations.
It is understood that argatroban is a new-generation anticoagulant, belonging to the class of small-molecule direct thrombin inhibitors. Its formulations are primarily used in clinical treatment of peripheral arterial occlusive disease, as well as for the prevention or treatment of arterial thrombosis.
Focusing on a business development strategy centered on “active pharmaceutical ingredients (APIs) + finished dosage forms,” Shijiazhuang No.4 Pharmaceutical Group has vigorously pursued efforts to extend, supplement, and strengthen its core industries. Significant progress has been made in the R&D of specialty dosage forms and APIs. Since the beginning of this year, the company has obtained a total of 26 product approvals, including 16 finished dosage form varieties and 10 API varieties. Among these, four finished dosage form varieties have been approved for the first time by domestic pharmaceutical companies.
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