Tinidazole

Anaerobic infection is a common type of clinical infection involving multiple systems such as the abdominal cavity, gynecology, and oral cavity. Traditional metronidazole treatment has pain points such as high incidence of gastrointestinal adverse reactions and long course of treatment. As a new generation of nitroimidazole derivative, tinidazole exerts potent anti-anaerobic and anti-protozoal effects by inhibiting the DNA synthesis of pathogens and blocking their nucleic acid metabolism. Its antibacterial activity can reach 2 to 4 times that of metronidazole, and it has better tolerance. Clinically, it is mainly used for the prevention and treatment of postoperative anaerobic infections, as well as parasitic infections such as trichomoniasis, amebiasis, and giardiasis. It covers the diagnosis and treatment needs of multiple departments such as surgery, obstetrics and gynecology, and stomatology, and is currently one of the core drugs for the prevention and treatment of anaerobic infections.

At present, the global tinidazole market size exceeds 1.2 billion US dollars, with a compound annual growth rate of 3.8% in the past five years. The growth momentum mainly comes from the increasing demand for anti-infective drugs in primary medical institutions and the steady growth of surgical volume. China is the world's largest producer of tinidazole API, with production capacity accounting for more than 65% of the global total capacity. The domestic market has basically achieved domestic substitution, and the approved oral and injection dosage forms involve more than 170 approval numbers. After the centralized procurement, the price of oral dosage forms has dropped by 72%, and the clinical accessibility has been greatly improved.

The original research enterprise of tinidazole is Pfizer, with the original brand name Tindamax, and its core compound patent in the United States expired in 2007. The original marketed dosage forms include 250mg and 500mg tablets, which have been included in the FDA Reference Listed Drug Catalog. The original formulation is not marketed in China, and the domestic reference listed drug is an imported generic drug. As of now, there are a total of 22 tinidazole API registration records on the CDE API registration platform, of which 14 have been activated with A status and can be associated with the marketing of domestic preparations. The domestically approved tinidazole preparations cover multiple dosage forms such as tablets, capsules, injections, and suppositories. (Data as of November 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of tinidazole impurity reference standards, which can cover the whole process of R&D needs including impurity qualitative, quantitative research and stability investigation. Most products are in stock, and orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for the quality research and registration declaration of API and preparation enterprises.