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ABOUT USSSY Group Limited is a large high-tech pharmaceutical enterprise with coordinated development of R&D and industrialization in multiple fields such as new drugs, generic drugs, characteristic APIs
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RECRUITIt has established high-level innovation platforms such as engineering laboratory and technology research center jointly with Chinese Academy of Sciences, and now has nearly 400 high-level talents in drug research, analysis and clinical research.
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CONTACTWe will continue to strengthen innovation-driven development, will vigorously encourage the integration of production and research, strengthen and improve the five domains: new drugs, biological drugs, traditional Chinese medicine, generic drugs and APIs
Shijiazhuang Sihua Pharmaceutical Group’s Norepinephrine Bitartrate Injection and Phloroglucinol Injection Approved on the Same Day
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发布时间：2024-08-27
【概要描述】
On August 27, Shijiazhuang Sihua Pharmaceutical Group’s applications for two pharmaceutical products—the Class 3 chemical drug Norepinephrine Bitartrate Injection (4 mL: 8 mg) and the Class 4 chemical drug Phloroglucinol Injection (4 mL: 40 mg)—were both granted drug production registration approvals by the National Medical Products Administration on the same day, and are deemed to have passed the consistency evaluation.
On August 27, Shijiazhuang Sihua Pharmaceutical Group’s applications for two products—the Class 3 chemical drug Norepinephrine Bitartrate Injection (4 mL: 8 mg) and the Class 4 chemical drug Phloroglucinol Injection (4 mL: 40 mg)—were both granted drug production registration approvals by the National Medical Products Administration on the same day, and are deemed to have passed the consistency evaluation.
According to available information, Norepinephrine Bitartrate Injection is indicated for blood pressure management in certain acute hypotensive conditions, such as post–adrenalectomy, post–sympathectomy, poliomyelitis, spinal anesthesia, myocardial infarction, sepsis, transfusion reactions, and drug-induced hypotension; it is also used as an adjunctive therapy for cardiac arrest and severe hypotension. In cases of shock due to hypovolemia, this product serves as an adjunct to volume replacement during resuscitation to elevate blood pressure and temporarily maintain cerebral and coronary perfusion until volume expansion therapy takes effect; it may also be employed to maintain blood pressure following resuscitation from cardiac arrest. Phloroglucinol Injection is indicated for the treatment of acute spasm-related pain caused by gastrointestinal and biliary tract dysfunction, acute spastic urethral, bladder, and renal colic, and gynecological spasm-related pain.
To date, the group has had 102 drug varieties comprising 135 dosage forms either approved or deemed to have passed the bioequivalence evaluation for generic drugs.
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