Domiphen Bromide

As a broad-spectrum bacteriostatic agent, domiphen bromide belongs to the cationic surfactant class of disinfectant and antiseptic drugs. Its mechanism of action is to adsorb onto bacterial cell walls, alter cell membrane permeability, and cause the exosmosis of bacterial cell contents, thereby achieving the effect of killing or inhibiting Gram-positive bacteria, some Gram-negative bacteria and fungi. It is mostly used for skin and mucous membrane disinfection in clinical practice, and can also be used for adjuvant treatment of upper respiratory tract infections such as pharyngitis and tonsillitis. It can also be used as the core component of oral care preparations, suitable for daily disinfection and mild infection care of the general population, and is also widely used in scenarios such as skin and instrument disinfection before surgical operations.

At present, the overall domestic market size of domiphen bromide is approximately 320 million yuan, with a compound annual growth rate maintained at around 4.8%. The downstream demand is mainly concentrated in the two major fields of oral care products and medical disinfectant preparations, accounting for 62% and 31% respectively. In terms of the competitive landscape, domestic manufacturers occupy an absolute dominant position, with CR3 (concentration ratio of the top three enterprises in the industry) exceeding 72%, the share of imported products being less than 5%, and there are no relevant centralized procurement implementation records for now, so the market competition is relatively stable.

The original research enterprise of domiphen bromide is Bayer AG of Germany, and the original research trade name is "Domiphen Bromide". The core compound patent expired globally in 1989. At present, the mainstream dosage forms include disinfectant solution (specifications of 0.02%-0.1%) and buccal tablets (0.5 mg/tablet). The original research product has been included in the FDA Reference Listed Drug Catalog, and the original research preparation has not been imported into China. On the domestic front, the CDE API registration platform currently includes a total of 3 valid registration numbers for domiphen bromide, all of which are approved by domestic manufacturers, and the status is all A (can be used in marketed preparations); the domestically approved domiphen bromide preparations cover multiple varieties such as domiphen bromide buccal tablets and domiphen bromide solution, and the preparation products of many local enterprises have been launched for sale. (Data as of October 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for domiphen bromide API. Most of the products are in stock, and orders for in-stock products placed before 16:00 will be shipped on the same day. They fully meet the requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the enterprise's needs for impurity reference standards in the process of API R&D, quality research and production, helping to improve R&D efficiency and ensure compliance.