Shijiazhuang Sihua Pharmaceutical Group’s Pivmecillinam Raw Material Drug Approved


发布时间:2023-04-10

【概要描述】 On April 7, the application submitted by Hebei Guangxiang Pharmaceutical Co., Ltd., a subsidiary of Shijiazhuang Sihua Pharmaceutical Group, for tedizolid phosphate was approved by the National Medical Products Administration, officially registering it as an active pharmaceutical ingredient for use in marketed dosage forms. This marks the group’s fourth new API designation this year.
On April 7, the application submitted by Hebei Guangxiang Pharmaceutical Co., Ltd., a subsidiary of Shijiazhuang Sihua Pharmaceutical Group, for tedizolid phosphate was approved by the National Medical Products Administration, officially registering it as an active pharmaceutical ingredient for use in marketed dosage forms. This marks the group’s fourth new API designation this year.
According to reports, tedizolid phosphate is indicated for the treatment of acute bacterial skin and skin-structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus (including methicillin-resistant [MRSA] and methicillin-susceptible [MSSA] isolates), Streptococcus pyogenes, Streptococcus agalactiae, the Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus), and Enterococcus faecalis.
In recent years, Shijiazhuang Sihua Pharmaceutical Group has actively pursued a “API-plus-formulation” development strategy, aligning its innovation efforts with the industrial value chain. As a result, the efficiency of API development has steadily increased, with four distinctive APIs approved since 2023, thereby significantly boosting the quality and efficiency of the company’s formulation business.

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