Cefixime

Cefixime is a third-generation oral cephalosporin antibiotic, which exerts antibacterial activity by inhibiting the synthesis of bacterial cell walls. It has strong bactericidal effects on Streptococcus and Streptococcus pneumoniae among Gram-positive bacteria, as well as Neisseria gonorrhoeae, Escherichia coli, Klebsiella, Haemophilus influenzae among Gram-negative bacteria, and has clinical advantages of stability against β-lactamase, high oral bioavailability, and low incidence of adverse reactions. It is clinically mainly used for the treatment of multi-site infections caused by susceptible bacteria, including bronchitis, pneumonia, pyelonephritis, cystitis, gonococcal urethritis, cholecystitis, otitis media, sinusitis, etc. Its applicable population covers adults and children weighing more than 30 kg, and it is a commonly used oral antibacterial drug for the treatment of community-acquired infections.

The domestic market size of cefixime has long been among the top of oral antibacterial drugs. In 2023, the overall market size was approximately RMB 4.5 billion, of which the preparation market accounted for more than 90%, and the demand for API maintained a steady annual growth of around 6%. In terms of competition pattern, there are more than 200 approvals for domestic generic cefixime preparations. After the implementation of centralized procurement, the price of preparations has dropped significantly. The localization rate of upstream API has reached 92%, with leading manufacturers concentrated in Guangdong, Zhejiang, Fujian and other regions, and imported API accounts for less than 8%. The overall market has sufficient competition, and cost control capability has become the core competitive element of upstream suppliers.

The original research enterprise of cefixime is Fujisawa Pharmaceutical Co., Ltd. of Japan (now Astellas Pharma), with the original trade name "Cefspan", and the trade name marketed in China is "Ceclor". The compound patent of this product expired in 2001, and the core preparation patent in China expired in 2007. The dosage forms of the original research drug approved in China include capsules (50mg, 100mg) and granules (50mg), which have been included in the China Listed Medicines Catalogue as reference preparations. In terms of API registration, as of now, there are more than 30 valid registration numbers of cefixime API on the CDE API registration platform, among which more than 20 are in A status. There are more than 230 domestic approved cefixime preparation approvals, covering capsules, granules, dispersible tablets, dry suspensions and other dosage forms. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for cefixime API, covering all types of reference standards including synthetic impurities, degradation impurities, enantiomers, etc. Most of the products are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can directly support the full-process requirements of API quality research, consistency evaluation and registration declaration.