Chlordiazepoxide

In the clinical diagnosis and treatment of anxiety disorders and alcohol withdrawal syndrome, benzodiazepines are one of the core options for relieving acute symptoms. As the world's first commercially available benzodiazepine sedative-hypnotic, chlordiazepoxide exerts anti-anxiety, sedative-hypnotic, anti-convulsant and skeletal muscle relaxant effects by enhancing the inhibitory effect of central γ-aminobutyric acid (GABA). It is not only suitable for the symptomatic treatment of adult anxiety disorders and short-term insomnia, but also can be used for the intervention of tremor and delirium symptoms in patients with alcohol withdrawal syndrome, and can be used as a preoperative adjuvant drug to relieve patients' tension.

The global sedative-hypnotic API market has maintained a compound annual growth rate of 4.2% in recent years, among which benzodiazepines account for about 18% of the overall market share. As a classic variety, chlordiazepoxide has a stable market demand of around 320 tons per year. In terms of competitive landscape, the patent of this product has expired for more than 40 years, and it is currently mainly supplied by generic drugs. China and India are the two major production regions in the world, accounting for more than 75% of the global production capacity in total. The domestic market is not included in the scope of national centralized volume procurement at present, the price of preparations fluctuates slightly, and the supply pattern of APIs is relatively scattered.

The original research enterprise of chlordiazepoxide is Roche, and the original research trade name is Librium. The core compound patent expired globally in 1979. The main dosage forms approved by the original research include 5mg, 10mg and 25mg oral tablets, which have been included in the FDA Reference Listed Drug Catalog. The original research product has not been included in the *Catalog of Reference Preparations for Chemical Drugs* in China for the time being. At present, there is no approved A-status registration number for chlordiazepoxide on the domestic API registration platform, and only 2 enterprises have submitted registration applications which are under the review stage. The domestic marketed preparations are all domestic generic drugs at present, and no original research preparations have been approved for import. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for chlordiazepoxide, most of which are in stock. Orders placed before 16:00 can be shipped on the same day. The products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the relevant needs of pharmaceutical enterprises in quality research, registration and declaration, as well as routine production quality control.