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CONTACTWe will continue to strengthen innovation-driven development, will vigorously encourage the integration of production and research, strengthen and improve the five domains: new drugs, biological drugs, traditional Chinese medicine, generic drugs and APIs
Shijiazhuang Sihua Pharmaceutical Group’s 200 mL Ciprofloxacin Lactate and Sodium Chloride Injection Has Been Approved
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发布时间：2023-01-05
【概要描述】
At the start of the new year, Shijiazhuang Sihua Pharmaceutical Group announced exciting news in its research and development: its 200 mL ciprofloxacin lactate sodium chloride injection—containing 0.4 g of ciprofloxacin lactate (calculated on the basis of C17H18FN3O3) and 1.8 g of sodium chloride—has been approved by the National Medical Products Administration and is deemed to have passed the evaluation of quality and therapeutic equivalence for generic drugs. This dosage form is the second in the country to receive such approval.
At the start of the new year, Shijiazhuang Sihua Pharmaceutical Group announced encouraging news in its research and development efforts: the successful development of a 200 ml ciprofloxacin lactate sodium chloride injection—containing 0.4 g of ciprofloxacin lactate (calculated on the basis of C 17 H 18 FN 3 O 3 calculated) and 1.8 g of sodium chloride obtained Approved by the National Medical Products Administration and deemed to have passed the evaluation of quality and therapeutic equivalence for generic drugs, this dosage form is the second in the country to receive such approval.
According to available information, ciprofloxacin lactate and sodium chloride injection is a fluoroquinolone antibiotic indicated for the treatment of systemic infections caused by susceptible bacteria, including genitourinary tract infections, respiratory tract infections, gastrointestinal infections, typhoid fever, bone and joint infections, skin and soft tissue infections, and sepsis.
Previously, the company developed a 100 ml ciprofloxacin lactate sodium chloride injection [ciprofloxacin lactate 0.2 g (calculated as C 17 H 18 FN 3 O 3 The 200 mL specification of ciprofloxacin lactate sodium chloride injection, along with the 100 mL specification, was the first in China to pass the evaluation of quality and therapeutic equivalence for generic drugs in 2021. This newly approved 200 mL formulation builds on the company’s previously approved 100 mL product, further expanding and refining the product portfolio for this drug.
Currently, Shijiazhuang Sihua Pharmaceutical has achieved bioequivalence for 32 drug varieties encompassing 43 dosage forms and strengths, laying a solid foundation for optimizing its product portfolio and enhancing its competitiveness in the market.
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