Cefazolin Sodium/Sodium Chloride Injection for Injection Obtained Drug Registration Approval

June 16, 2025  Source: drugdu 68

"/Kelun PharmaceuticalIt was disclosed on the evening of June 12 that the chemical drug "Cefazolin Sodium/Sodium Chloride Injection for Injection" of the company's subsidiary Hunan Kelun Pharmaceutical Co., Ltd. recently obtained drug registration approval from the State Food and Drug Administration.

Disclosures show that cefazolin sodium is a classic drug for anti-infective treatment. It is currently widely used in clinical practice for various perioperative preventive medications and treatment of respiratory tract, skin and soft tissue, bone and joint infections caused by sensitive bacteria. It is also the only cephalosporin recognized by WHO as the preferred choice for surgical prevention. Cefazolin Sodium/Sodium Chloride Injection for Injection is a Class B national medical insurance product. In 2024, sales of cefazolin sodium injection in China will reach 1.35 billion yuan. The Cefazolin Sodium/Sodium Chloride Injection for Injection for which Kelun Pharmaceutical has obtained a drug registration certificate is a powder-liquid double-chamber bag, with 1.0g of cefazolin (C14H14N8O4S3) in the powder chamber and 0.9g of sodium chloride injection in 100ml in the liquid chamber. The company is also the second domestic company approved for powder-liquid double-chamber bag packaging.

The powder-liquid double-chamber bag is an internationally advanced infusion product, in which the powder and liquid are located in two independent chambers respectively, ensuring the stability of the drugs in each chamber before mixing. It can be opened, mixed and used immediately during clinical use, which can effectively avoid the risks of mismatch and contamination during the preparation process, while saving preparation time, reducing preparation workload and lowering the exposure risk of medical staff. It is especially suitable for rapid treatment in emergency situations.

Through continuous independent innovation, Kelun Pharmaceutical has created aThe intelligent production and manufacturing system for powder-liquid bags has formed core technical barriers around special film materials, equipment technology and process technology, and has more than 40 core patents. By integrating AI technology and production information management systems, it further enriches and enhances the informatization, digitization and intelligence of the production and manufacturing system. Cefazolin Sodium/Sodium Chloride Injection is the 11th approved product of the company's powder-liquid double-chamber bag platform, and there are currently multiple varieties of this platform under development.

https://finance.eastmoney.com/a/202506123429107416.html

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