Difenidol

In the clinical treatment of vestibular dysfunction-related symptoms such as vertigo and vomiting, anti-vertigo drugs are the core choice for improving patients' travel and quality of life, and difenidol is a commonly used variety that combines safety and cost-effectiveness. As a first-generation antihistamine anti-vertigo drug, it exerts its effect by blocking excessive excitation of vestibular receptors and inhibiting the chemical trigger zone of the vomiting center. It can rapidly relieve motion sickness symptoms caused by riding in cars or on ships without central sedation, and is also applicable to nausea and vomiting reactions caused by diseases such as Meniere's disease and postoperative vertigo. Its applicable population covers adults and children over 6 months old, and it is a commonly used symptomatic treatment drug in clinical settings and households.

At present, the global market size of anti-motion sickness drugs is approximately USD 1.9 billion, with a compound annual growth rate maintained at around 4.2%. Among them, difenidol has a stable share in the primary medical care and OTC markets due to its cost-performance advantage. In the domestic market, difenidol preparations have been included in the national medical insurance Class B catalogue and are classified as OTC Class A varieties. There are currently more than 20 preparation enterprises approved for production, the generic drug market is fully competitive, the demand for API remains stable for a long time, with an annual consumption of more than 100 tons, and there is no relevant centralized procurement policy implemented so far.

The original research enterprise of difenidol is SSP CO., LTD. of Japan, with the original brand name Cephadol, and the core compound patents have expired in all major global markets. At present, the mainstream dosage form approved in China is 25mg tablets, and its original preparation is not included in the reference preparation catalogue of China NMPA, so domestic generic drugs all carry out consistency evaluation with domestically marketed domestic preparations as the reference. As of November 2024, there are 12 difenidol API registration entries on the CDE API registration platform, 8 of which are in Status A and can be used in association with domestic preparation declarations. More than 15 difenidol oral preparations have been approved for marketing in China. (Data as of November 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for difenidol API, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products comply with the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the demand for impurity reference standards in API R&D, quality research and consistency evaluation.