Dirithromycin

As a new generation of macrolide antibiotics, dirithromycin binds to the 50S subunit of ribosomes of sensitive bacteria to inhibit bacterial protein synthesis. Its antibacterial spectrum covers Gram-positive bacteria, some Gram-negative bacteria and atypical pathogens. Compared with erythromycin, it has stronger acid stability and longer half-life. It is mainly used clinically to treat respiratory tract infections such as acute exacerbation of chronic bronchitis, acute bronchitis, community-acquired pneumonia, pharyngitis and tonsillitis, and can also be used for the treatment of skin and soft tissue infections. It is suitable for patients over 12 years old who are allergic to penicillins or infected with sensitive bacteria, with high medication convenience and low incidence of adverse reactions.

The global market size of dirithromycin is approximately USD 230 million, and the compound annual growth rate from 2023 to 2028 is expected to remain at 2.1%. The growth mainly comes from the stable demand for oral anti-infective drugs from primary medical institutions. In terms of the domestic market, this variety has been included in the centralized procurement catalogs of multiple provinces, and the price of the selected preparations has dropped by more than 70%, making cost control the core competitiveness of enterprises. At present, the domestic supply of API is dominated by local enterprises, with import dependence of less than 5%, and the top 3 enterprises account for about 82% of the market share.

The original research enterprise of dirithromycin is Boehringer Ingelheim, Germany, with the original brand name "Normoc". Its US compound patent expired in 2004, and its core patent in China expired in 2003. The dosage form approved by the original research is enteric-coated tablets, with mainstream specifications of 250mg and 500mg, which has been included in the FDA Reference Listed Drug Catalog. Up to now, there are 12 dirithromycin API registration records on China CDE API Registration Platform, of which 8 are in status "A" (approved for use in marketed preparations), and more than 20 domestic enterprises have obtained marketing approval for dirithromycin enteric-coated preparations. (Data as of September 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of dirithromycin impurity reference standards, supporting the full-process needs of drug research and development and quality control. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and complete structure confirmation and standardization reports can be provided simultaneously.