Cefdinir

Cefdinir is a third-generation oral cephalosporin antibiotic that exerts a bactericidal effect by inhibiting the synthesis of bacterial cell walls. It has broad-spectrum antibacterial activity against both Gram-positive and Gram-negative bacteria, and its antibacterial effect against Gram-positive bacteria such as *Staphylococcus aureus* and *Streptococcus pneumoniae* is superior to that of traditional oral cephalosporins. Clinically, it is mainly used to treat pharyngitis, tonsillitis, acute bronchitis, pneumonia, otitis media, sinusitis, pyelonephritis, cystitis, gonococcal urethritis, and skin and soft tissue infections caused by sensitive bacteria. Its applicable population covers adults and children, and it is a commonly used oral antibacterial drug for the treatment of community-acquired infections.

The global cefdinir market size has maintained a steady growth trend for a long time. In 2023, the market size was approximately USD 1.28 billion, with the Chinese market accounting for more than 35%. The domestic market has formed a pattern of full competition between original research drugs and generic drugs. As of 2024, more than 20 enterprises have obtained approval for the marketing of cefdinir preparations. After the centralized drug procurement, the price of oral dosage forms has dropped by more than 70%, which has driven the continuous improvement of the penetration rate in primary medical institutions, and the annual growth rate of the corresponding API demand is maintained at around 8%. At present, the domestic production of cefdinir API is mainly concentrated in North China and East China, and leading enterprises account for more than 60% of the market share.

The original research enterprise of cefdinir is Astellas Pharma of Japan, with the original brand name "Cefzon" (Chinese brand name "世福素"). The expiration date of its core compound patent in major markets such as Japan and the United States is 2005, and the expiration date of the compound patent in China is 2006. The main dosage forms approved for the original research drug include capsules (50mg, 100mg) and granules (50mg), which have been included in the *Catalogue of Chemical Reference Preparations* of China and the FDA Reference Preparation Catalogue. In terms of domestic API registration, as of 2024, 11 enterprises have obtained CDE registration numbers (status A) for cefdinir API, and more than 30 enterprises have obtained approval for the marketing of cefdinir preparations such as capsules and granules. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of cefdinir impurity reference standards. Most products are available from stock. For in-stock orders placed before 16:00, delivery can be made on the same day. All products meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and fully meet various compliance needs of API R&D, quality research and routine production testing.