Diazepam

Anxiety disorders and epilepsy are mental and neurological diseases with high incidence globally, with annual prevalence rates of 3.8% and 0.7% respectively. There has been a long-term urgent clinical need for sedative and anticonvulsant treatment options that combine safety and efficacy. Diazepam is a long-acting benzodiazepine central nervous system depressant. By enhancing the binding of γ-aminobutyric acid (GABA) to GABA_A receptors, it increases the opening frequency of chloride ion channels, exerting anti-anxiety, sedative-hypnotic, anticonvulsant, anti-epileptic and skeletal muscle relaxation effects. Clinically, it can be used for the treatment of anxiety disorder, insomnia, status epilepticus and tetanus convulsion, and can also be used as pre-anesthetic medication to relieve patients' preoperative tension. The applicable population covers adult patients and some pediatric populations requiring convulsion control.

The global market size of diazepam preparations is stable at around USD 2.3 billion, with a compound annual growth rate of approximately 2.1%. The growth mainly comes from the expansion of sedation demand in primary care and the increase in the penetration rate of standardized epilepsy treatment. As a classic drug that has been on the market for more than 60 years, the diazepam market is dominated by generic drugs, accounting for more than 98%. China is the world's largest producer of diazepam API, with an annual output of more than 1,500 tons, supplying nearly 70% of the global market demand. The domestic market has been included in the national centralized procurement, and the price of winning preparations has dropped by more than 85%, greatly improving the accessibility of medication for patients.

The original developer of diazepam is Roche, with the original brand name Valium. The core compound patent expired globally in 1985. The main dosage forms approved for the original product include tablets (2mg, 5mg, 10mg), injection (2ml:10mg), rectal gel, etc. Its tablets and injection have been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China, and are also listed in the FDA Reference Preparation Catalogue. At present, more than 20 enterprises have obtained approved registration (status A) of diazepam API on the CDE API Registration Platform of China, and dozens of domestic enterprises have obtained marketing approval for diazepam tablets and injection. (Data as of July 2025, please refer to the official website of CDE for the latest information.)

CATO provides a full set of impurity reference standards for diazepam API, covering all research needs such as synthesis process impurities and degradation impurities. Most products are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the use needs of various reference standards in the stages of API R&D, production and quality research.