Cefonicid

For the clinical treatment of moderate to severe bacterial infections such as lower respiratory tract infections, urinary tract infections, and sepsis, second-generation cephalosporins have always been a commonly used anti-infective option in clinical practice due to their characteristics of covering both Gram-positive and Gram-negative bacteria and high safety. Cefonicid, a representative long-acting variety of second-generation cephalosporins, exerts a bactericidal effect by inhibiting the synthesis of bacterial cell walls. The N-methylthiotetrazole side chain in its molecular structure can prolong the half-life of the drug, requiring only once-daily administration, which greatly improves patients' medication compliance. It is suitable for the treatment of various infections caused by susceptible bacteria in adults, and can also be used for the prevention of surgical site infections.

In the current domestic anti-infective drug market, the overall scale of cephalosporin preparations exceeds 60 billion yuan, among which the market share of long-acting second-generation cephalosporin varieties is continuously increasing. The average annual market growth rate of cefonicid preparations has reached 12% in the past three years, and the terminal sales in domestic public medical institutions exceeded 1.5 billion yuan in 2023. In terms of the competitive landscape, there are more than 20 manufacturers of existing generic preparations. After the implementation of centralized procurement, the market share of the original research drug has dropped to less than 10%. There is still a certain gap in the supply of upstream API, and there is no absolutely dominant supplier.

The original research enterprise of cefonicid is GlaxoSmithKline, with the original brand name "Monocid". Its core compound patent expired globally in 2009. The main dosage form approved for the original research drug is cefonicid sodium for injection, covering two specifications of 0.5g and 1.0g, which has been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs*. In terms of domestic API registration, at present, 6 enterprises have obtained A-status registration numbers for their cefonicid sodium APIs after passing the review of the CDE, and more than 30 domestic manufacturers have been approved to produce cefonicid sodium preparations, realizing comprehensive import substitution. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of cefonicid impurity reference standards, which can meet the impurity research needs of different process routes and support enterprises to complete API registration and declaration and consistency evaluation work. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can be directly used in experiments related to quality research and stability investigation.