Cephacetrile

As a first-generation semi-synthetic cephalosporin anti-infective drug, cefacetrile exerts a bactericidal effect by inhibiting the biosynthesis of bacterial cell walls. It has strong antibacterial activity against Gram-positive bacteria including *Staphylococcus aureus*, *Streptococcus pneumoniae*, and *Streptococcus pyogenes*, and also has a certain effect on some Gram-negative bacteria such as *Escherichia coli* and *Proteus mirabilis*. Clinically, it is mainly used for respiratory system infections, urinary system infections, biliary tract infections, skin and soft tissue infections, and postoperative infections caused by susceptible bacteria, and is applicable to adults and patients with mild to moderate infections who are not allergic to penicillins. Due to its relatively low renal toxicity, it still has application value in the treatment of mild infections in elderly patients with renal tolerance.

The current global market size of first-generation cephalosporin API is approximately USD 3.2 billion, with a compound annual growth rate maintained at around 2.1%. Among them, the market size of the cefacetrile segment is approximately USD 120 million, and the demand is mainly concentrated in the anti-infective drug use scenarios of primary medical institutions in developing countries. In terms of the domestic market, cefacetrile is not currently included in the scope of the national centralized volume-based procurement, and the competition pattern is relatively relaxed. The number of domestic API manufacturers is less than 5, and the market supply gap can reach about 15% in some periods.

The original research enterprise of cefacetrile is Fujisawa Pharmaceutical Co., Ltd. of Japan, with the original brand name "Celospor", and its core compound patent expired worldwide in 1991. The main dosage form approved by the original research is cefacetrile sodium for injection, with specifications of 0.5g and 1.0g. The original product is not included in the *Catalogue of Chemical Reference Preparations* of China, and this variety is not included in the FDA Reference Preparations Catalogue either. Up to now, the Center for Drug Evaluation (CDE) of the National Medical Products Administration has not yet publicized the valid registration number (A status) of cefacetrile API, and no relevant cefacetrile preparations have been approved for marketing in China. (Data as of September 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of cefacetrile impurity reference standards. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the impurity comparison needs of the whole process of API R&D, quality research, production quality control, etc.