Midecamycin

Macrolide antibacterial drugs are an important category for clinical use against Gram-positive bacteria and Mycoplasma infections. As a representative second-generation variety of this category, midecamycin exerts its antibacterial effect by binding to the 50S subunit of bacterial ribosomes and inhibiting bacterial protein synthesis. Its antibacterial spectrum covers common pathogenic bacteria such as Staphylococcus aureus, Streptococcus hemolyticus and Streptococcus pneumoniae, and its gastrointestinal adverse reactions are significantly lower than those of the first-generation erythromycin. Clinically, it is mainly used for the treatment of respiratory tract infections, skin and soft tissue infections, biliary tract infections and Mycoplasma pneumoniae pneumonia caused by susceptible bacteria. It is suitable for adult and pediatric patients with mild infections, and is a common option for sequential treatment of community-acquired infections.

At present, the market size of macrolide antibacterial drugs in China exceeds RMB 12 billion. Among them, with the characteristics of low drug resistance and high safety, midecamycin has a steadily increasing proportion in primary medical institutions and pediatric medication scenarios, with a compound annual growth rate of 6.8% in the past three years. Domestic manufacturers mainly produce generic drugs. At present, more than 10 enterprises have obtained preparation approval documents. The production capacity of API is mainly concentrated in Jiangsu and Guangdong. The overall competition pattern is relatively scattered, and no leading monopoly enterprise has emerged. In addition, this variety is not included in the national centralized volume procurement catalog, so the price system is relatively stable.

The original research enterprise of midecamycin is Meiji Seika Pharma Co., Ltd. of Japan, with the original brand name "Midecamycin". The core compound patent expired worldwide in 1999. At present, the main dosage forms approved in China include enteric-coated tablets, capsules and granules, with common specifications of 0.1g and 0.2g. The original research product has not been imported into China, and the domestic reference preparations are all domestic generic drugs that have passed the consistency evaluation, which are included in the *Catalogue of Reference Preparations for Generic Chemical Drugs (52nd Batch)*. The domestic API registration platform has publicly announced 12 valid A-status registration numbers, all of which are produced by domestic enterprises. In addition, there are 8 I-status registrations under review, and the supporting preparation approval documents exceed 70. The upstream supply chain has been fully localized. (Data as of October 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for midecamycin, and most of the products are available from stock. Spot orders paid before 16:00 can be shipped on the same day. All reference standards meet the requirements of Chinese Pharmacopoeia, FDA and other national regulations, and can fully cover the needs of the whole process of R&D and production scenarios such as API quality research, consistency evaluation and release testing.