Good News! Shijiazhuang No.4 Pharmaceutical has developed moxifloxacin hydrochloride ophthalmic solution and levofloxacin sodium chloride injection, while the Group’s Guangxiang Pharmaceutical has had three epalrestat API products consecutively approved.
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TIME:2022-03-19
【SUMMARY】
On March 18, two Class 4 chemical pharmaceutical products developed by Shijiazhuang Sihua Pharmaceutical Co., Ltd.—moxifloxacin hydrochloride ophthalmic solution and levofloxacin sodium chloride injection—were granted Drug Registration Certificates by the National Medical Products Administration and are 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 dosage forms.
The spring breeze brings 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 has 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 and may now be used 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 Sihua 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 pipeline 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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