Cefazolin

For the prevention and control of perioperative infections caused by Gram-positive bacteria, cefazolin has always been the first-generation cephalosporin drug of clinical choice. It inhibits the activity of bacterial cell wall mucopeptide synthetase, blocks the synthesis of the basic structure of the cell wall, and ultimately leads to the swelling and death of bacteria. It has strong bactericidal activity against common pathogenic bacteria such as Staphylococcus, Streptococcus, and Klebsiella pneumoniae. It is widely used in the clinical treatment of infections in the respiratory tract, urinary tract, skin and soft tissues, bone joints and other sites, and is also the preferred drug for preventing postoperative infections in various types of clean surgeries. Its applicable population covers adults and pediatric patients without a history of cephalosporin allergy, and the clinical demand for the drug is long-term and stable.

As a basic anti-infective drug with mature clinical application, the global market size of cefazolin has maintained a steady growth of about 2.8% in recent years, and the annual sales in the domestic market are stable at more than 3.5 billion yuan. In terms of the competitive landscape, the domestic preparation market has fully achieved domestic substitution, in which leading enterprises such as North China Pharmaceutical and Qilu Pharmaceutical occupy more than 60% of the market share; on the API side, domestic production capacity accounts for more than 75% of the global total production capacity, and China is the core supplier of cefazolin API in the world. With the continuous advancement of the national centralized drug procurement, the price of winning preparations has dropped by more than 80%, which has further driven the increase in demand for upstream APIs.

The original research enterprise of cefazolin is Fujisawa Pharmaceutical Co., Ltd. of Japan, and the original brand name is "CEFAZOLIN SODIUM FUJISAWA". Its core compound patent expired globally in 1979. At present, the main dosage form of the original research product on the market is injection, with conventional specifications of 0.5g and 1g. The original research preparation has been included in the FDA Reference Listed Drug Catalog, and is also included in China's *Catalog of Reference Preparations for Chemical Drugs*. Regarding domestic API registration, as of now, there are a total of 22 cefazolin API registration numbers, of which 18 have been publicized in Status A. There are more than 300 approvals for cefazolin sodium for injection approved for marketing in China, and the clinical supply is sufficient. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full series of cefazolin impurity reference standards, which meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA. Most of the impurities are in stock. Orders for in-stock products placed before 16:00 can be shipped on the same day, which can provide efficient and reliable reference standard support for pharmaceutical enterprises in API quality research, preparation stability investigation and other work.