Hexamidine

In the field of skin anti-infective therapy, aromatic diamidine compounds have always occupied an important position due to their unique broad-spectrum antibacterial activity, and hexamidine is a representative ingredient with relatively mature clinical application in this category. Its mechanism of action is to highly selectively bind to pathogen DNA and inhibit nucleic acid synthesis, which has definite inhibitory effects on Gram-positive bacteria, Gram-negative bacteria and fungi. Meanwhile, it has mild anti-inflammatory properties and rarely causes skin irritation reactions. At present, this ingredient is mainly used for the adjuvant treatment of common superficial skin infections such as acne, seborrheic dermatitis and scalp folliculitis, and can also be added as a disinfectant and preservative to post-medical aesthetic care and daily washing and care products, covering most groups except adults and children with sensitive skin.

The global market size of hexamidine-related end products was approximately USD 470 million in 2023, and the compound annual growth rate from 2024 to 2030 is expected to remain at around 5.2%. The growth momentum mainly comes from the expanding demand in the functional skin care track and the popularization of skin anti-infective drugs in primary medical institutions. At present, the global production capacity of hexamidine API is mainly concentrated in Europe and China, among which European enterprises account for about 63% of the high-end medicinal grade raw material market. With cost advantages, domestic enterprises have seen their market share in the washing and care grade raw material field increase year by year in recent years, and there is no verifiable data related to the centralized procurement of public medical institutions for the time being.

The original research enterprise of hexamidine is Laboratoires Expanscience, a French company, with the original brand name Hexomedine. The core compound patent of hexamidine expired in Europe and the United States in 1999, and the compound patent in China has passed the protection period. The main dosage form approved by the original research is topical solution, with the specification of 0.1% hexamidine diisethionate solution, which has been included in the list of marketed drugs of France and the EU EMA, and has not been included in the *Catalogue of Reference Preparations of Chemical Drugs* issued by the China NMPA for the time being. As of the retrieval time, there is no hexamidine-related A-status registration number on the API registration platform of China CDE, and no hexamidine single preparation has been approved for marketing in China. Only a few compound dermatological topical preparations and cosmetic grade products contain this ingredient. (Data as of November 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for hexamidine API. The products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA. Most varieties are in stock, and orders placed before 16:00 can be shipped on the same day, which can fully meet the reference substance use needs of pharmaceutical enterprises in the whole process of R&D, quality research and registration declaration.