Cefotaxime

As a core variety of the third-generation semi-synthetic cephalosporins, cefotaxime exerts its antibacterial activity by inhibiting the synthesis of bacterial cell wall mucopeptides. Its effect against Gram-negative bacteria is significantly better than that of the first and second-generation cephalosporins, and it is highly stable to β-lactamase. It is a commonly used drug in clinical treatment of respiratory tract infections, genitourinary system infections, sepsis, abdominal infections caused by sensitive bacteria and prevention of perioperative infections. The applicable population covers adults and children who meet the medication indications, and it is a basic medication option in the treatment pathways of community and nosocomial bacterial infections.

The global market size of cefotaxime has been steadily above 1.5 billion US dollars for years. As a major producer of generic drugs, China's domestic market size exceeds 2 billion yuan, with an average annual growth rate of around 3.2% in the past three years. The current domestic competitive landscape is dominated by generic drugs, with the market share of original research products being less than 8%. The domestic suppliers of API are mainly large pharmaceutical enterprises in North China and East China. After the implementation of centralized procurement, the terminal price of preparations has dropped by more than 60%, driving the upstream demand for API to continuously concentrate on leading enterprises with stable production capacity and strong cost control ability.

The original research enterprise of cefotaxime is Hoechst-Roussel Pharmaceuticals, with the original brand name "Claforan". The core compound patent was first approved in 1976, and all patents in major global markets expired before 2000. The common dosage form of the original reference listed drug is injection, with specifications including 0.5g, 1.0g and 2.0g. Among them, the 0.5g and 1.0g specifications have been included in the *Catalogue of Reference Listed Drugs of Chemical Drugs* issued by China NMPA, and are also listed in the FDA Reference Listed Drug Catalogue. Up to now, there are more than 30 cefotaxime API registration numbers on China CDE API Registration Platform, among which nearly 20 are in status A, which can meet the associated review needs of domestic preparation enterprises. More than 60 domestic enterprises have obtained approval for marketing of cefotaxime for injection. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of cefotaxime impurity reference standards, which can meet the impurity research needs of different production processes. The products comply with the relevant regulatory requirements of the Chinese Pharmacopoeia and FDA. Most products are in regular stock. Orders for in-stock products paid before 16:00 can be shipped on the same day, fully meeting the multi-scenario reference standard needs of API and preparation enterprises for quality research, stability study, release inspection, etc.