Ornidazole

For inflammations in the abdominal cavity, pelvic cavity, oral cavity and other parts caused by anaerobic bacterial infections, nitroimidazole drugs have long been relied on clinically to control the progression of infection. Ornidazole is the third-generation nitroimidazole derivative following metronidazole and tinidazole. Its mechanism of action is that the nitro group in its molecule is reduced to an amino group in an anaerobic environment, or free radicals are formed to interact with cellular components, eventually leading to the death of microorganisms. Compared with previous generations of drugs, ornidazole has the advantages of broad anti-anaerobic spectrum, strong antibacterial activity, long half-life, low incidence of adverse reactions, etc. It is currently widely used in pre-surgical infection prevention, post-surgical treatment of anaerobic bacterial infections, as well as the treatment of parasitic infections such as trichomoniasis and amoebiasis, and the applicable population covers adults and children.

The scale of China's ornidazole market has maintained stable growth for a long time. In 2023, the overall market size was approximately 2.8 billion yuan, with the preparation segment accounting for more than 85%. The demand for APIs continues to expand along with the increase in the clinical usage of preparations. In terms of the competitive landscape, more than 30 domestic enterprises have obtained approval for generic ornidazole preparations. In the sixth batch of nationally organized drug centralized procurement in 2021, ornidazole injection was included in the centralized procurement scope, with an average price reduction of over 60% for winning bids, which further promotes the increase of clinical penetration rate. The upstream API supply is dominated by local enterprises, with sufficient overall capacity that can fully meet the incremental market demand after centralized procurement.

The original research enterprise of ornidazole is Roche, with the original brand name Tiberal. The core compound patent expired globally in 2003. At present, the mainstream dosage forms include tablets, capsules, injections and suppositories, and common specifications cover 0.25g, 0.5g, 100ml:0.5g, etc. Its original preparation has been included in the FDA Reference Listed Drug Catalog, and relevant ornidazole dosage forms as reference listed drugs have also been included in the *List of Chemical Drugs* in China. Up to now, more than 20 domestic enterprises have obtained Class A status for their ornidazole APIs through CDE registration, and the approved and marketed preparation varieties cover all dosage forms including oral, injectable and topical ones. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for ornidazole API. The products simultaneously meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA. Most products are available in stock. Stock orders placed before 16:00 can be shipped on the same day, which can fully meet the reference standard usage needs in the process of API R&D, quality research and production.