Bromazepam

The global prevalence of anxiety disorders is increasing year by year, with the characteristics of chronic progression and high comorbidity rate, and the clinical demand for sedative-hypnotic drugs with fast onset and excellent tolerance continues to rise. Bromazepam is a benzodiazepine sedative-hypnotic, which binds to the γ-aminobutyric acid A receptor in the central nervous system to enhance the conduction effect of inhibitory neurotransmitters, and has the effects of anti-anxiety, sedative-hypnotic and anticonvulsant. It is mainly used clinically for the short-term treatment of anxiety disorders, and can also adjuvantly improve sleep disorder symptoms accompanied by anxiety. It is applicable to adult patients with anxiety disorders and patients with anxiety symptoms secondary to somatic diseases, and is one of the commonly used basic therapeutic drugs in the neuropsychiatric field.

The current global market size of benzodiazepine APIs is approximately USD 2.8 billion, among which the anti-anxiety segment maintains a compound annual growth rate of around 3.2%. As a second-line anti-anxiety drug recommended by clinical guidelines, bromazepam has a stable market demand. The supply side presents a pattern where European pharmaceutical companies dominate and enterprises in emerging markets gradually enter the market. At present, there is no large-scale supply of generic bromazepam APIs in China, and the preparations for clinical use have long relied on imports, so there is a clear space for domestic substitution in the market.

The original developer of bromazepam is Roche, with the original brand name Lexotanil, and its core compound patent expired in 1980. The main dosage form approved for the original drug is tablet, with two specifications of 1.5mg and 3mg. It has been included in the FDA Reference Listed Drug Catalog, and also included in the *Catalogue of Reference Preparations for Chemical Drugs (Fourth Batch)* of China. At present, there is no domestically produced bromazepam preparation approved for marketing in China, and there is no approved domestic bromazepam API registration number (A status) on the API registration platform, and only a small number of imported preparations are supplied to clinical practice through officially approved channels. (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 bromazepam APIs, which fully meet the full-process requirements of generic drug R&D and quality research. Most products are in stock, and in-stock orders placed before 16:00 can be shipped on the same day. All products comply with the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can help pharmaceutical companies efficiently promote the R&D and declaration work of generic bromazepam drugs.