Guangxiang Pharmaceutical of Shijiazhuang Sihua Pharmaceutical Group Receives Approval for Nicethamide API


TIME:2025-01-02

【SUMMARY】 On December 30, Nicethamide, developed by Hebei Guangxiang Pharmaceutical Co., Ltd. of Shijiazhuang Sihua Pharmaceutical Group, was approved by the National Medical Products Administration and registered as an active pharmaceutical ingredient for use in marketed dosage forms. To date, the Group has a total of 67 API products.

On December 30, Nicethamide, developed by Hebei Guangxiang Pharmaceutical Co., Ltd. of Shijiazhuang Sihua Pharmaceutical Group, was approved by the National Medical Products Administration and registered as an active pharmaceutical ingredient for use in marketed dosage forms. To date, the Group has a total of 67 API products.

According to available information, nicethamide API is primarily used for central respiratory depression and respiratory depression caused by various etiologies; it is a class of central stimulant drugs, and its injectable formulation is mainly indicated for the treatment of conditions such as respiratory or circulatory failure.

In the first batch of “Challenge-based Recruitment” projects for critical core technologies and products in the industrial sector, announced by the Hebei Provincial Department of Industry and Information Technology in January of this year, Guangxiang Pharmaceutical Group successfully secured the contract to develop a manufacturing process for nicethamide API. This project primarily addresses the challenges associated with nicethamide—its susceptibility to oxidation, stringent transportation and storage requirements, and difficulties in scaling up production—thereby laying the foundation for the industrial-scale production of nicethamide API.

Keywords: