Moxifloxacin hydrochloride and sodium chloride injection has been approved for marketing

On May 8, 2019, moxifloxacin hydrochloride and sodium chloride injection, the latest generation of quinolones antibacterial drug, independently researched and developed by Qidu Pharmaceutical Co., Ltd., was approved for drug registration. The package specification was 250ml NON-PVC multi-layer coextrusion film soft bag, and its registered document of approval for medicine is NMPN-H20193111. Moxifloxacin’s API and preparation has passed the bunding review at once.


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Products’ quality comes from design. The research and development process of moxifloxacin hydrochloride and sodium chloride injection is another witness of the scientific research and development work of Qidu Pharmaceutical Co., Ltd. and the pursuit of first-class team work style. In order to solve the problem that the epimer of moxifloxacin cannot be obtained and the absolute configuration is difficult to determine, the project team members selected more than ten kinds of crystallization conditions of single crystal, carried out synchronous experiments under various environments, and finally cultivated moxifloxacin single crystal, and proved its absolute configuration by single crystal X-ray diffraction experiment. Through the selection of experimental parameters, analysis of powder diffraction data and comparison of domestic and foreign literatures, it is proved that the crystal form of our product is consistent with that of the original research. In order to solve the problem of difficult purification of API, through massive literature research, the project team explored dozens of refining conditions, selected different solvent ratio, and finally determined the refining method that can control the single impurity below 0.1% stably, and the purity of the product reached more than 99.90%. In order to solve the problems of complex structure, high impurity and quality control of moxifloxacin, the project team synthesized a number of impurities that could not be obtained in the market, which provided a guarantee for the smooth progress of quality research. The quality researchers developed more than ten analytical methods to analyze nearly thirty impurities, including possible residues, genotoxic impurities and photodegradable impurities in starting materials, intermediate products and finished products. Which makes the quality of the product reached the standard of European Pharmacopoeia and American Pharmacopoeia. In order to solve the problem of sensitive to metal ions, the personnel of the preparation research project team investigated every metal contact point in the production process, do everything possible to collect dozens of containers of different materials and same material but different weight from equipment manufacturers and building materials manufacturers, and designed the EDTA cycle and non-cycle comparison test scheme, and finally tightened the heavy metal limit and ensured the completion of the workshop's large-scale production.


Over the past 20 years, Qidu pharmaceutical has always been concerned about and committed to the research and development of fluoroquinolones. Levofloxacin, ciprofloxacin, ofloxacin, pazufloxacin and other products have been launched in the market successively. Among them, Dinuoxin levofloxacin hydrochloride and sodium chloride injection and levofloxacin hydrochloride tablets, which obtained the production license and new drug certificate in 2001, are the first new drug products declared by the company since its restructuring, occupying an important position in the development history of Qidu pharmaceutical industry and making important contributions to the development of the enterprise. Since going public, Dinuoxin has occupied a place under pressure of the complex and changeable market environment. Among them, injection packaging covers glass bottles, polypropylene bottles, upright polypropylene bags, Non-PVC double-valve double aseptic film soft bags and Non-PVC film-covering soft bags. It has become the most complete levofloxacin products’ brand in domestic dosage forms, dosage, packaging materials and specifications. In recent years, the annual sales revenue of single product has exceeded 100 million yuan for nine consecutive years. It has won the honors of famous trademark of Shandong Province, famous brand product of Shandong Province, excellent anti-infection product brand of Chinese chemical pharmaceutical industry, and the most powerful brand of Chinese medicine.


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Moxifloxacin hydrochloride is the fourth generation of quinolones antibiotics. It has a wide antibacterial spectrum, which covers the pathogen completely, has low resistance rate, dual effect targets, high degree of safety and dual-channel metabolism, and is widely used in clinical treatment. It has more obvious advantages in the treatment of respiratory tract infection, known as "respiratory quinolones", which has become a key recommended variety in many medication guidelines at home and abroad, and was included in the new national essential drug list in 2018. The compound growth rate of the product in recent five years has reached 17%. In 2018, the sales volume of sample hospitals exceeded 1.6 billion yuan, which is the product with the largest market capacity and fastest growth rate of quinolones. After 3-5 years of efforts, Qidu pharmaceutical will build moxifloxacin hydrochloride and sodium chloride injection into another heavy product of quinolone anti-infective drugs, further enhance the company's product competitiveness in the field of anti- infection treatment, and provide important support for product structure optimization, market structure adjustment and enterprise transformation and development.

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