罗红霉素

Respiratory tract infection is an infectious disease with high incidence worldwide. Macrolide antibiotics have always been one of the core options for clinical treatment due to their broad antibacterial spectrum and low incidence of allergic reactions. As a second-generation semi-synthetic macrolide drug, roxithromycin inhibits protein synthesis by reversibly binding to the 50S subunit of bacterial ribosomes, and has good antibacterial activity against Gram-positive bacteria, anaerobes, mycoplasma, chlamydia, etc. It is mainly used clinically to treat pharyngitis, tonsillitis, sinusitis, otitis media, pneumonia, urethritis and skin and soft tissue infections, and the applicable population covers adult and pediatric patients with sensitive bacterial infections. Compared with the first-generation erythromycin, it has higher fat solubility and milder gastrointestinal adverse reactions, and its oral bioavailability can reach 70%~80%.

At present, the global roxithromycin market size is stable at around US$1.2 billion, with a compound annual growth rate maintained at 2.3%. Among them, the Chinese market accounts for more than 35%, making China the largest producer and consumer of roxithromycin in the world. In terms of competitive landscape, domestic generic drugs occupy an absolute dominant position, with more than 600 existing preparation approvals. With the advancement of the centralized procurement policy, the price of preparations has dropped by more than 60%, and the demand for upstream API has further concentrated on leading manufacturing enterprises. The total domestic API production capacity has exceeded 3,000 tons per year, and in addition to meeting domestic demand, nearly 40% of the production capacity is used for export.

The original research enterprise of roxithromycin is Hoechst AG of Germany (later merged into Sanofi), and the original research brand name is "Claramid". Its core compound patent expired globally in 2003. The main dosage forms approved for the original research product include tablets, capsules and dry suspensions, with specifications covering 50mg, 75mg, 150mg and 300mg. The original research product has been included in the FDA Reference Listed Drug Catalog and the Chinese *Catalog of Reference Preparations for Chemical Drugs*. At present, more than 40 domestic enterprises have completed CDE registration of roxithromycin API (more than 20 A-status registration numbers), and the approved preparation varieties cover all mainstream dosage forms, with extremely high clinical accessibility. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of roxithromycin impurity reference standards. Most of the 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 regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the various needs of API R&D, quality research and routine release testing.