Metronidazole

For common clinical conditions such as periodontal abscess, bacterial vaginosis and amoebic dysentery caused by anaerobic bacterial infections, metronidazole is one of the antibacterial drugs with a very high usage rate in primary medical institutions due to its stable bacteriostatic effect and high safety. As a nitroimidazole derivative, its mechanism of action is to generate cytotoxic substances through reduction in anaerobic bacterial cells, block the synthesis and replication of pathogen DNA, thereby rapidly inhibiting the proliferation of pathogenic bacteria. Meanwhile, it also has a definite killing effect on parasitic pathogens such as trichomonas and entamoeba histolytica, and is applicable to both adults and children. It is a core anti-infective drug included in the National Essential Medicines List.

As an anti-infective basic drug with rigid clinical demand, the global market size of metronidazole maintains a steady growth trend. In 2023, the global market size was approximately USD 1.28 billion, with a compound annual growth rate of around 3.2%. The domestic market is currently dominated by generic drug supplies. There are more than 600 approved manufacturing approvals for metronidazole preparations, and oral conventional-release dosage forms have been included in the national centralized procurement scope. The winning bid price has dropped by about 72% compared with that before the centralized procurement. Domestic enterprises dominate the API supply side, the overall market pattern is highly mature, and the supply stability is strong.

The original research manufacturer of metronidazole is Sanofi, and the original research brand name is Flagyl®. The compound patent in the US market expired in 1982, and all core preparation patents have also entered the public domain. At present, the mainstream dosage forms of the original research product in the global market include 250mg and 500mg oral tablets, 0.5% intravenous injection, and corresponding vaginal suppositories. The original research preparation has been included in the FDA Reference Listed Drug Catalog and the China Listed Drug Catalog. In terms of domestic API registration, more than 30 enterprises have obtained A status for their metronidazole APIs through CDE registration, which can be legally supplied to domestic preparation manufacturers. The domestically approved metronidazole preparations cover all dosage forms such as oral, injection and external use. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of metronidazole impurity reference standards. Most products are in stock, and for in-stock products, orders placed before 16:00 will be shipped on the same day. Meanwhile, all products comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, which can fully meet the reference standard use needs in the whole process of API R&D, quality research, registration and declaration, etc.