Sihuan Pharmaceutical has secured drug registration approval from China’s National Medical Products Administration (NMPA) for its non-PVC solid-liquid double chamber bag for ceftazidime/sodium chloride injection.
Image: Sihuan Pharma has secured Chinese approval for non-PVC soft bag infusion product. Photo: courtesy of moritz320 / Pixabay.
The non-PVC solid-liquid double chamber infusion soft bag (formulation), developed jointly by Sihuan Pharmaceutical and its associated company Beijing Ruiye Drugs Manufacture, is provided with high technology barriers and offers long development cycle.
At present, the products of this formulation have only been produced by pharmaceutical firms in the US and Japan.
Non-PVC soft bag infusion products are common in the intravenous solution market of countries such as the US and Japan, said Sihuan.
The formulation helps to eliminate secondary contamination in the dispensing process caused by microorganisms and particles. It also helps avoid drug allergies to medical staff, which occur during the infusion preparation.
Sihuan’s solid-liquid double chamber bag product will help replace some of the existing products, noted Sihuan.
The new formulation uses specific processes, as well as non-PVC multi-layer co-extrusion film as packaging materials and encloses the drug and solvent injection into the two chambers of the same packaging that are separated by empty solder.
Sihuan’s product is an exclusive formulation of ceftazidime/sodium chloride injection. Ceftazidime, a semi-synthetic third-generation cephalosporins antibiotics, is mainly used to treat sepsis, lower respiratory tract infection, abdominal and biliary tract infection and severe skin and soft tissue infection caused by sensitive gram-negative bacilli.
According to the company, all the ceftazidime currently approved for production in China are powder injection.
Sihuan Pharmaceutical chairman and CEO Dr Che Fengsheng said: “The approval of the Product will further enrich the Group’s product line in the area of anti-infective drugs, as well as firmly establish the Group’s leading position in the area of non-PVC solid-liquid double chamber infusion soft bag, thus contributing the Group’s development in the antibiotic intravenous solution market.
“Beijing Ruiye has other subsequent products of this Formulation, which includes four varieties and six specifications of cefuroxime and cefodizime that are under review and are expected to be launched to market after obtaining the approval for drug registration.”