Good News! Shijiazhuang No.4 Pharmaceutical has had its moxifloxacin hydrochloride ophthalmic solution and levofloxacin sodium chloride injection approved, while Guangxiang Pharmaceutical of the Group has received approval for three API varieties of epalrestat in succession.


发布时间:2022-03-19

【概要描述】 On March 18, Shijiazhuang Sihua Pharmaceutical Co., Ltd. obtained Drug Registration Certificates from the National Medical Products Administration for two Class 4 chemical drugs—moxifloxacin hydrochloride ophthalmic solution and levofloxacin sodium chloride injection—and these products are deemed to have passed the evaluation of quality and therapeutic equivalence for generic drugs. In addition, the epalrestat active pharmaceutical ingredient submitted by Hebei Guangxiang Pharmaceutical Co., Ltd., a subsidiary of Shijiazhuang Sihua Pharmaceutical Group, has also been approved by the National Medical Products Administration for use in marketed dosage forms.
Spring winds bring good news, heralding new developments in pharmaceutical R&D. On March 18, Shijiazhuang Sihua Pharmaceutical Co., Ltd. received Drug Registration Certificates from the National Medical Products Administration for two Class 4 chemical drugs it developed: moxifloxacin hydrochloride ophthalmic solution and levofloxacin sodium chloride injection. These products are also deemed to have passed the evaluation of quality and therapeutic equivalence for generic drugs. In addition, the epalrestat API submitted by Hebei Guangxiang Pharmaceutical Co., Ltd., a subsidiary of Shijiazhuang Sihua Pharmaceutical Group, has also been approved by the National Medical Products Administration for use in marketed formulations.
According to reports, moxifloxacin hydrochloride ophthalmic solution is primarily indicated for the treatment of bacterial conjunctivitis caused by susceptible microorganisms and represents Shijiazhuang No.4 Pharmaceutical’s first approved ophthalmic formulation. Levofloxacin is a fluoroquinolone antibiotic mainly used to treat respiratory, urinary, genitourinary, skin and soft-tissue, intestinal, and other infections caused by susceptible bacteria. Epalrestat formulations are primarily indicated for the treatment of diabetic neuropathy. The approval of these three new products will further enhance the Group’s portfolio of formulated products and specialty APIs.
To date, Shijiazhuang Sihua Pharmaceutical has had 20 drug varieties and 28 dosage forms either approved or deemed to have passed the consistency evaluation.

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