Therapy Areas: Cardiovascular
Sihuan Pharmaceutical Holdings Group Ltd wins NMPA drug registration approval for non-PVC solid-liquid double chamber bag
28 May 2019 -

Cardio-cerebral vascular company Sihuan Pharmaceutical Holdings Group Ltd (HKEx:0460) revealed on Monday the receipt of the drug registration approval for its non-PVC solid-liquid double chamber bag for ceftazidime/sodium chloride injection from the National Medical Products Administration (the NMPA) of China.

The non-PVC solid-liquid double chamber bag for ceftazidime/sodium chloride injection is jointly developed by Sihuan and its associate Beijing Ruiye Drugs Manufacture Co Ltd. Sihuan is the first Chinese company to receive the drug registration approval for the non-PVC solid-liquid double chamber bag in the nation.

All the ceftazidime currently approved for production in China are powder injection. The non-PVC solid-liquid double chamber infusion soft bag (the formulation) has high technology barriers and long development cycle. This formulation is currently one of the technologically advanced new formulations of intravenous solution.

Additionally, the soft bag formulation avoids secondary contamination in the dispensing process caused by microorganisms and particles and solves drug allergies of medical staff during the infusion preparation. It has significant strengths in the application of emergencies and extreme situations. It has been recognized as the safest and most convenient infusion product and is considered as one of the new formulations with great development potential in the pharmaceutical industry, Sihuan stated.

Ceftazidime is a semi-synthetic third-generation cephalosporins antibiotic used for treating sepsis, lower respiratory tract infection, abdominal and biliary tract infection, urinary tract infection and severe skin and soft tissue infection. It is applicable with explicit efficacy to the infection of immunodeficiency patients caused by resistant gram negative bacilli, nosocomial infection and central nervous system infection caused by gram negative bacilli or pseudomonas aeruginosa, concluded the company.

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