Shijiazhuang Sihua Pharmaceutical’s three signature new products—Bunan Selin Tablets, Acetaminophen Mannitol Injection, and Levofloxacin Injection—were approved on the same day.
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发布时间:2022-06-21
【概要描述】
On June 16, three distinctive, high-potential new drug products—bupropion tablets (4 mg), acetaminophen-mannitol injection (100 ml: 1,000 mg), and levofloxacin injection (20 ml: 0.5 g, calculated on the basis of C18H20FN3O4)—developed and manufactured by Shijiazhuang Sihua Pharmaceutical Co., Ltd., were granted drug registration certificates by the National Medical Products Administration.
In the height of midsummer, as the fragrance of ripening wheat fills the air, Shijiazhuang No. 4 Pharmaceutical Co., Ltd. is also reaping a bountiful harvest of research and development innovations. On June 16, the company received drug registration certificates from the National Medical Products Administration for three distinctive, high-potential new products it has developed: Bunanxilin Tablets (4 mg), Acetaminophen Mannitol Injection (100 ml: 1,000 mg), and Levofloxacin Injection (20 ml: 0.5 g, calculated on the basis of C18H20FN3O4). This milestone underscores that, following continuous optimization of its R&D systems and mechanisms and robust talent development, Shijiazhuang No. 4 Pharmaceutical has entered a concentrated “harvest period” of scientific innovation.
The bupropion tablets approved this time by Shijiazhuang Sihua Pharmaceutical fall under Category 4 of chemical drugs, while the other two injectable solutions are classified as Category 3 of chemical drugs; both are deemed to have passed the consistency evaluation. Notably, the bupropion tablets, primarily indicated for the treatment of schizophrenia, represent the first approval of their kind for a domestic pharmaceutical company. The concurrently approved acetaminophen-mannitol injection is indicated for relieving fever in adults and likewise marks the first such approval by a domestic manufacturer. The levofloxacin injection is used for the treatment or prevention of infections that have been proven or are strongly suspected to be caused by susceptible bacteria.
Over the past two years, Shijiazhuang Sihua Pharmaceutical has aligned its innovation strategy with the industrial value chain, positioning technological innovation as the cornerstone of the company’s high-quality development. The company allocates nearly 10% of its core business revenue to R&D, effectively accelerating its transition onto a fast track of innovative growth. To date this year, a total of 20 new-product projects have been approved, averaging more than three per month. The company’s research and development in generic drug innovation ranks among the top in the domestic industry, while it has also submitted applications for approval on an additional 31 new-product projects. These innovative achievements are being rapidly commercialized, continuously injecting fresh momentum into the company’s high-quality development, robustly promoting and driving the optimization of the product portfolio and the upgrading of market positioning, and helping the company expedite its transformation and upgrading to move up the value chain.
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