Spiramycin

As a macrolide antibiotic that has been in clinical application for more than half a century, spiramycin exerts its antibacterial activity by reversibly binding to the 50S subunit of bacterial ribosomes to inhibit protein synthesis, and has good inhibitory effects on Gram-positive bacteria, some Gram-negative bacteria, Rickettsia and Toxoplasma gondii. It is mostly used clinically for respiratory tract infections and skin and soft tissue infections caused by sensitive bacteria. Meanwhile, it is the first-choice drug for the prevention and treatment of Toxoplasma gondii infection during pregnancy, and can also be used for the treatment of immunocompromised patients with cryptosporidiosis. Its safety and efficacy have been widely verified in long-term clinical practice.

The global spiramycin market size is approximately USD 320 million, and the compound annual growth rate from 2023 to 2028 is expected to remain at 2.1%. The growth momentum mainly comes from the expansion of primary-level anti-infection demand and the increase in demand for parasitic disease prevention and control. The current market is dominated by generic drugs. China is the world's largest producer and exporter of spiramycin API, with production capacity accounting for more than 75% of the total global supply. The products of leading domestic manufacturers have passed GMP certifications in multiple international markets, and their supply covers dozens of countries and regions in Europe, Southeast Asia, Latin America, etc.

The original developer of spiramycin is Sanofi, with the original brand name "Rovamycine", and the core compound patent expired worldwide in 1999. The already marketed dosage forms of the original drug include tablets, capsules and dry suspensions, with common specifications of 1.5 million IU and 3 million IU. Its tablets and dry suspensions are both included in the FDA Reference Listed Drug Catalog, and are also the main source of reference preparations for marketed preparations in China. As of now, there are 6 valid registration numbers for spiramycin API on the CDE API Registration Platform in China, 3 of which are in Status A and can be used for associated domestic preparation declaration. More than 20 domestic enterprises have obtained approval for the marketing of spiramycin oral preparations. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of spiramycin impurity reference standards. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. They fully comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the needs of API enterprises for quality research, impurity calibration and preparation of declaration materials.