头孢呋辛酯

Bacterial infections in the respiratory system, urinary system and other parts have long ranked at the forefront of visits for clinical infectious diseases, and the spread of drug-resistant bacteria has put forward higher requirements for the safety and effectiveness of clinical anti-infective drugs. Cefuroxime axetil is a second-generation oral cephalosporin antibiotic, which exerts a bactericidal effect by inhibiting the synthesis of bacterial cell walls, and has good antibacterial activity against gram-positive bacteria and some gram-negative bacteria. It is mainly used clinically to treat acute pharyngitis, tonsillitis, acute bronchitis, uncomplicated urinary tract infections, skin and soft tissue infections, etc. caused by sensitive bacteria. Its applicable population covers adults and children who meet the medication indications, and it is a commonly used basic drug for clinical oral anti-infective treatment.

At present, the global market size of cefuroxime axetil has exceeded 1.8 billion US dollars, and the compound growth rate in the past three years has maintained at around 3.7%. China is the world's largest producer and exporter of cefuroxime axetil API, with its production capacity accounting for more than 72% of the total global production capacity. In terms of the domestic market, this variety has been included in multiple batches of national centralized procurement catalogs, and the price of the selected preparations has dropped by more than 85%, driving the sustained and steady growth of downstream API demand. At present, domestic API manufacturers are mainly local manufacturers, and the total market share of the top 3 enterprises exceeds 60%, with a high industry concentration.

The original developer of cefuroxime axetil is GlaxoSmithKline, with the original brand name "Zinnat/西力欣", and its core compound patent expired in China in 2009. The main dosage forms approved for the original product include tablets and dry suspensions. The specifications of tablets are 0.125g, 0.25g and 0.5g, and the specification of dry suspension is 0.125g per sachet. The original product has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also a reference preparation announced by the FDA. Up to now, there are more than 30 valid registration numbers of cefuroxime axetil on the CDE API registration platform, among which more than 20 registration numbers are in Status A. Many domestic enterprises have been approved to produce cefuroxime axetil preparations such as tablets, capsules and dry suspensions. (Data as of October 2024, please refer to the official CDE website for the latest data)

CATO can provide a full set of impurity reference standards for cefuroxime axetil API. Most of the products are available from stock. Spot orders placed before 16:00 can be shipped on the same day. All products meet the requirements of pharmacopoeial regulations of multiple countries including the Chinese Pharmacopoeia and FDA, and can fully meet the full-process R&D and production needs of API and preparation manufacturers such as quality research, qualitative and quantitative analysis of impurities, and compliance declaration.