Great news! Three products developed by Shijiazhuang No.4 Pharmaceutical—moxifloxacin hydrochloride eye drops, levofloxacin sodium chloride injection, and ipratropium bromide raw material—have been approved one after another by the Group’s Guangxiang Pharmaceutical.


Time:2022-03-19

【概要描述】 On March 18, two Class 4 chemical drugs developed by Shijiazhuang Sihua Pharmaceutical Co., Ltd.—moxifloxacin hydrochloride eye drops and levofloxacin sodium injection—obtained “Drug Registration Certificates” issued by the National Medical Products Administration (NMPA) and are deemed to have passed the evaluation of consistency in quality and efficacy for generic drugs. In addition, the active pharmaceutical ingredient epalrestat, submitted by Hebei Guangxiang Pharmaceutical Co., Ltd., a subsidiary of Shijiazhuang Sihua Group, has also been approved by the NMPA and can now be used in marketed formulations.
The spring breeze brings joyful news—R&D ushers in a new era for meteorology. On March 18, two chemical drugs developed by Shijiazhuang No.4 Pharmaceutical Co., Ltd.—moxifloxacin hydrochloride eye drops and levofloxacin sodium injection—obtained the “Drug Registration Certificates” issued by the National Medical Products Administration and are deemed to have passed the evaluation of consistency in quality and efficacy with generic drugs. In addition, the active pharmaceutical ingredient epalrestat, submitted by Hebei Guangxiang Pharmaceutical Co., Ltd., a subsidiary of Shijiazhuang No.4 Pharmaceutical Group, has also been approved by the National Medical Products Administration and can now be used in marketed formulations.
It is reported that moxifloxacin hydrochloride eye drops are primarily used to treat bacterial conjunctivitis caused by susceptible microorganisms, and represent Shijiazhuang Fourth Pharmaceutical’s first approved ophthalmic formulation. Levofloxacin belongs to the fluoroquinolone class of antibiotics and is mainly indicated for the treatment of respiratory tract infections, urinary tract infections, genital tract infections, skin and soft tissue infections, intestinal infections, and other infections caused by susceptible bacteria. Epalrestat preparations are primarily used for the treatment of diabetic neuropathy. The approval of these three new products will further enrich the Group’s pipeline of formulated products and specialty active pharmaceutical ingredients.
As of now, Shijiazhuang Fourth Pharmaceutical has 20 varieties and 28 specifications of products that have either passed or been deemed to have passed the consistency evaluation.

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