Cefodizime

For the clinical treatment of common bacterial infections such as community-acquired pneumonia and urinary tract infection, third-generation cephalosporin drugs have long occupied the core position of infectious disease medication due to their broad-spectrum antibacterial activity and medication safety. As the only variety in this category with both immunomodulatory functions, cefodizime exerts a bactericidal effect by inhibiting the synthesis of bacterial cell walls, and at the same time enhances the ability of the body's phagocytes to clear pathogenic bacteria. It is not only suitable for patients with normal immune function suffering from moderate to severe susceptible bacterial infections, but also demonstrates irreplaceable clinical advantages in infected populations with combined immunodeficiency, making it an important option in the current stepwise anti-infective treatment regimen.

As an anti-infective drug in mature clinical use, the global market size of cefodizime has long been stable at more than 1.5 billion yuan, with China's market share accounting for over 60%. In recent years, driven by the advancement of hierarchical diagnosis and treatment and the increase in demand for infection medication at the primary level, its compound annual growth rate has been maintained at around 3.2%. In terms of the competitive landscape, the market share of the original research product is less than 10%, and domestic generic preparations dominate the market. Domestic API manufacturers are concentrated in North China and East China. After the implementation of volume-based procurement, the demand of preparation enterprises for high-quality and highly compliant APIs continues to rise, and cost control and impurity research capabilities have become the core competitive factors for upstream suppliers.

The original research enterprise of cefodizime is Merck KGaA, Germany, with the trade name "Modivid". The core compound patent expired globally in 2002. The main dosage form approved for the original research product is cefodizime sodium for injection, which includes three specifications of 0.5g, 1.0g and 2.0g. Its preparation has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also listed as a reference preparation by the FDA. In terms of domestic API registration, nearly 20 enterprises have obtained CDE registration numbers for cefodizime sodium API so far, among which more than 10 are registered in Status A. The corresponding approved domestic cefodizime sodium for injection preparations have obtained more than 60 approval documents, with sufficient clinical accessibility. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of cefodizime impurity reference standards. Most of the products are in stock, and orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference substance use needs in the whole process of API R&D, quality research and production.