Good News Abounds: Two Products from Shijiazhuang Sihua Pharmaceutical Pass Evaluation, One Receives Priority Review
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发布时间:2022-04-07
【概要描述】
Recently, cefaclor dry suspension and metronidazole tablets submitted by Shijiazhuang Sihua Pharmaceutical Co., Ltd. were approved by the National Medical Products Administration following the evaluation of generic drug quality and therapeutic equivalence. In addition, the stibene dry suspension developed and submitted for approval has recently been included on the NMPA’s priority review list.
In the warm spring breeze of April, innovations bloom in vibrant competition. Recently, cefaclor dry suspension and metronidazole tablets, both submitted by Shijiazhuang Sihua Pharmaceutical Co., Ltd., were approved by the National Medical Products Administration following the evaluation of generic drug quality and therapeutic equivalence. Cefaclor dry suspension is primarily indicated for the treatment of infections caused by susceptible bacterial strains, while metronidazole tablets are mainly used for the treatment and prevention of infections due to anaerobic bacteria.
It is also learned that the stigmasterol dry suspension, developed and submitted for approval by Shijiazhuang Sihua Pharmaceutical, was recently included on the National Medical Products Administration’s Priority Review List. This marks the first time a product developed and submitted by the company has been added to such a list, and it represents an exclusive domestic submission. According to available information, the stigmasterol dry suspension is a rare-disease medication tailored to the physiological characteristics of children, primarily indicated for the treatment of severe myoclonic epilepsy in childhood.
Currently, Shijiazhuang Sihua Pharmaceutical has 22 drug varieties and 30 dosage forms that have either passed or are deemed to have passed the consistency evaluation.
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