Nanjing Vcare Helps Hainan Hualon Pharmaceutical to Pass the Consistency Evaluation of Aztreonam for Injection

2022-09-07

Recently, Hainan Hualon Pharmaceutical Co., Ltd. received the Approval Notice for Supplementary Drug Application issued by the National Medical Products Administration. Its product "Aztreonam for Injection (Specification: 0.5g/1.0g; Registration Classification: Chemical Drugs)" has passed the national consistency evaluation of the quality and efficacy of generic drugs.

 

 

Nanjing Vcare provided pharmaceutical consistency evaluation services for this product. The service contents included a series of research and development services such as preparation process, quality standards, stability, special safety tests, packaging material compatibility tests, and compatibility studies. Nanjing Vcare gave full play to the advantages of the whole-industrial-chain research and development service platform and effectively saved the development costs and time for the client. This project is also the third important project of Nanjing Vcare that has passed the consistency evaluation work after assisting Hainan Hualon Pharmaceutical Co., Ltd. to complete the consistency evaluations of "Omeprazole Sodium for Injection" and "Pantoprazole Sodium for Injection".

Aztreonam for Injection belongs to monocyclic β-lactam antibiotics and is mainly used for the treatment of various infections caused by sensitive aerobic Gram-negative bacteria, such as urinary tract infections, lower respiratory tract infections, septicemia, intra-abdominal infections, gynecological infections, postoperative wounds, and skin and soft tissue infections like burns and ulcers. It is also used for the treatment of the above types of infections in nosocomial infections (such as nosocomial infections in immunodeficient patients). Aztreonam for Injection is a Class B drug in the 2020 National Medical Insurance Catalogue. The passing of this product through the consistency evaluation will further enhance the market competitiveness of Hainan Hualon Pharmaceutical Co., Ltd.

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