Shijiazhuang Sihua Pharmaceutical Group’s telavancin phosphate API has been approved.


Time:2023-04-10

On April 7, the active pharmaceutical ingredient tedizolid phosphate, submitted 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 formulations. This is the group’s fourth new API variety obtained this year.
On April 7, the active pharmaceutical ingredient tedizolid phosphate, submitted by Hebei Guangxiang Pharmaceutical Co., Ltd. of Shijiazhuang Fourth Pharmaceutical Group, was approved by the National Medical Products Administration and has been registered as an API for use in marketed formulations. This is the group’s fourth new API variety obtained this year.
It is reported that 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 pyogenes group (including Streptococcus pyogenes, Streptococcus intermedius, and Streptococcus constellatus), and Enterococcus faecalis.
In recent years, Shijiazhuang Sihua Pharmaceutical Group has actively implemented a “API + Finished Dosage Form” development strategy, aligning innovation chains with industrial chains. As a result, the efficiency of API development has continued to accelerate. Since 2023, the company has been granted approval for four distinctive APIs, significantly boosting the quality and efficiency of its finished dosage form business.

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