Cefradine

Bacterial infectious diseases have always been a common category of clinical diagnosis and treatment. Cephalosporin antibiotics, with their broad antibacterial spectrum and high safety, occupy the core market share of anti-infective drugs. Cefradine is a first-generation semi-synthetic cephalosporin, which exerts its antibacterial effect by inhibiting the synthesis of bacterial cell walls, and has strong antibacterial activity against Gram-positive bacteria including penicillin-resistant Staphylococcus aureus. Clinically, it is mainly used for respiratory tract infections such as acute pharyngitis, tonsillitis, otitis media, bronchitis and pneumonia caused by sensitive bacteria, as well as urogenital tract infections, skin and soft tissue infections, etc. Its applicable population covers adults and children with body weight ≥ 20 kg, and it is one of the commonly used oral anti-infective drugs in primary medical institutions.

At present, the domestic market size of cefradine preparations is stably around 1.5 billion yuan, with an average annual compound growth rate of about 2.1% in the past three years, and the whole market is in a mature and stable stage. The competitive landscape is dominated by generic drugs, with more than 300 existing marketing approval numbers for preparations, and oral dosage forms accounting for more than 90%. After the implementation of the centralized procurement policy, the average price reduction of winning products reached 68%, and the market concentration is gradually shifting to leading enterprises with integrated API production capacity. The production capacity of APIs is mainly distributed in North China and East China, and the total market share of leading enterprises exceeds 70%.

The original research enterprise of cefradine is Bristol-Myers Squibb, with the original brand name Velosef, and the core compound patent expired in 1985. The main dosage forms approved by the original research include oral capsules (250 mg, 500 mg) and injections (0.5 g, 1 g). The original capsules have been included in the FDA Reference Listed Drug Catalog, and the original imported capsules can be selected as domestic reference preparations. There are more than 30 domestic A-status registration numbers for cefradine APIs, and more than 200 cefradine preparation varieties have been approved for marketing in China. (Data as of October 2024, please refer to the official website of CDE for the latest information)

In response to the needs of quality research of cefradine APIs and generic drug consistency evaluation, CATO provides a full set of impurity reference standards for this API, supporting the full-process research needs from impurity qualitative and quantitative analysis to stability investigation. Most of the products are in stock, and orders for in-stock products placed before 16:00 will be shipped on the same day. All impurities meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can directly meet the submission requirements of application materials.