Azithromycin

For the clinical treatment of community-prevalent infectious diseases such as lower respiratory tract infections and skin and soft tissue infections, macrolide antibiotics have long held the core position in medication. Among them, azithromycin, a second-generation derivative, has become one of the first-line clinical options due to its unique pharmacokinetic advantages. It reversibly binds to the 50S subunit of bacterial ribosomes, blocks the peptide chain elongation process and inhibits protein synthesis. Its antibacterial spectrum covers Gram-positive bacteria, some Gram-negative bacteria and atypical pathogens. In addition to the conventional treatment of adult infections, it is also a first-line medication for mycoplasma pneumoniae pneumonia in children, and can also be used for single-dose treatment of sexually transmitted diseases caused by Chlamydia trachomatis.

At present, the global market size of azithromycin API exceeds 1.2 billion US dollars, with a compound annual growth rate maintained at around 3.2%. China is the world's largest supplier, with a production capacity accounting for more than 70%. As the core patents for azithromycin in many countries have long expired, the global coverage of generic preparations continues to increase, driving the steady growth of demand for upstream API. After the implementation of the domestic centralized procurement policy, the procurement demand of winning preparation enterprises for compliant API has further expanded, and the supply of high-purity API that meets multiple pharmacopeia standards has remained in a tight balance.

CATO can provide a full set of impurity reference standards for azithromycin API. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and in-stock inventory can be shipped on the same day, which can save API manufacturers and preparation R&D enterprises from the tedious standard preparation process and accelerate the progress of quality research and registration declaration.