Cefditoren

In response to the clinical treatment needs of cross-infection caused by Gram-positive and Gram-negative bacteria, cefditoren, a third-generation oral cephalosporin antibiotic, occupies an important position due to its unique mechanism of action. By inhibiting the activity of transpeptidase in the process of bacterial cell wall synthesis and blocking the cross-linking reaction of peptidoglycan, it can effectively cover a variety of drug-resistant pathogenic bacteria such as Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, etc. Clinically, it is mainly used to treat community-acquired pneumonia, acute exacerbation of chronic bronchitis, acute sinusitis, otitis media, skin and soft tissue infections, etc., and is applicable to adults and pediatric patients over 6 months old, especially suitable for people with mild to moderate infections requiring oral sequential therapy.

The current global cefditoren market size maintains a steady growth trend. In 2023, the market size was approximately USD 210 million, with a compound annual growth rate of around 3.7%. In terms of the domestic market, the compound annual growth rate of cefditoren preparation sales at public medical institution terminals in the past five years has reached 6.2%, and sales exceeded RMB 800 million in 2023. The competitive landscape is dominated by generic drugs. At present, 12 domestic enterprises have obtained production approvals for cefditoren pivoxil preparations, and there is still a certain supply-demand gap in the API supply link, with the market acceptance of high-quality and compliant domestic APIs continuing to rise.

The original research enterprise of cefditoren is Meiji Seika Pharma Co., Ltd. of Japan, and the original research trade name is "Meiact". Its core compound patents expired in 2019 in major markets such as Japan and the United States, and the compound patent in China expired in 2020. The originally marketed dosage forms are mainly cefditoren pivoxil tablets, with specifications of 100mg and 200mg, which have been included in the *Reference Listed Drug Catalog of Chemical Drugs* issued by the National Medical Products Administration. Up to now, there are 6 cefditoren API registration numbers in China that are in the "A" status, and another 8 registration information items are under evaluation and approval. The domestically approved cefditoren pivoxil preparation varieties cover two dosage forms: tablets and granules. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of cefditoren impurity reference standards. Most products are available from stock, and orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple sets of regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the demand for impurity reference substances in the process of API R&D, quality research and routine production, helping enterprises accelerate the declaration and compliant production process of related varieties.