克拉霉素

As a representative upgraded variety of macrolide antibiotics, clarithromycin reversibly binds to the 50S subunit of bacterial ribosomes, blocks the translocation process of peptidyl transferase, and inhibits bacterial protein synthesis. It has definite antibacterial activity against Gram-positive bacteria, some Gram-negative bacteria, atypical mycobacteria and Helicobacter pylori. It is widely used in clinical practice for respiratory tract infections, skin and soft tissue infections, and combination therapy for Helicobacter pylori eradication. It is one of the core components of empirical medication for community-acquired infections and the quadruple regimen for Helicobacter pylori eradication in the gastroenterology department, covering multiple applicable groups such as adults and children.

In recent years, the global clarithromycin market size has maintained at around USD 1.8 billion, with a compound annual growth rate of approximately 2.3%. The growth momentum mainly comes from the increasing demand for anti-infective drugs in emerging markets and the growth of the penetration rate of Helicobacter pylori eradication therapy. China is the largest producer of clarithromycin API, with production capacity accounting for more than 70% of the global total. There are more than 20 existing API manufacturers, and the preparation market has formed a pattern of full competition between original research drugs and generic drugs. In 2022, clarithromycin tablets and capsules were included in the local centralized procurement scope, with an average price reduction of 56% for the winning bids, which further promoted the improvement of clinical accessibility.

The original research enterprise of clarithromycin is Abbott, with the original research brand name "Klacid". The expiration time of its core compound patent in the United States is 2005, and the Chinese compound patent expired in 2004. The main dosage forms approved for the original research include tablets (250mg, 500mg) and dry suspensions (125mg/5ml, 250mg/5ml). Relevant dosage forms have been included in the Chinese *Catalogue of Reference Preparations for Chemical Drugs* and the FDA Reference Preparation Catalogue. At present, there are more than 30 clarithromycin API registration numbers (status A) in China. The marketed preparations cover multiple dosage forms such as tablets, capsules, dry suspensions and granules, and the pass rate of generic drug consistency evaluation has exceeded 60%. (Data as of September 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of clarithromycin impurity reference standards. Most products are in regular stock. Orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the demand for impurity reference standards in the process of API R&D, quality research and production.