Midazolam

In perioperative sedation and anti-anxiety therapy, benzodiazepines have always been one of the core clinical options. As a second-generation short-acting benzodiazepine receptor agonist, midazolam specifically binds to the central γ-aminobutyric acid A receptor to enhance the conduction of inhibitory neurotransmitters, and has multiple advantages such as rapid onset, short half-life, no active metabolites, and significant anterograde amnesia effect. It is widely used clinically for anesthesia induction, anesthesia maintenance, ICU sedation, sedation during endoscopic procedures, and emergency treatment of status epilepticus. Its applicable population covers adults, children and elderly patients, and it is one of the most widely used sedative API in global clinical practice at present.

The global market size of midazolam has been steadily above USD 320 million for many years. It accounts for more than 11% of the domestic sedative drug market, with an annual growth rate of 6%~8%. The domestic market competition pattern shows a coexistence of original research drugs and generic drugs. At present, more than 15 enterprises have obtained the production qualification of midazolam preparations, among which the injection dosage form is the main variety in centralized procurement. In the fifth batch of national centralized procurement, the average price reduction of winning bids for midazolam injection reached 73%. The expansion of downstream preparation capacity directly drives the continuous rise of demand for upstream API.

The original research enterprise of midazolam is Roche, with the original brand name "Dormicum". Its core compound patent expired globally in 2001. The main dosage forms approved for the original drug include injections (1ml:5mg, 2ml:10mg, 5ml:50mg) and oral solutions (1mg/ml). The injection dosage form has been included in the China Listed Medicines Catalogue as a reference preparation, and is also listed in the FDA Orange Book Reference Preparation Catalogue. Up to now, there are 22 registration entries of midazolam API on the CDE API Registration Platform, among which 12 have been publicized with A status. More than 20 domestic enterprises have obtained marketing approval for midazolam injection and oral solution preparations. (Data as of July 2025, please refer to the official CDE website for the latest information)

In response to the quality control needs of midazolam, CATO provides a full set of impurity reference standards for this API, which can cover all categories including synthetic starting materials, intermediates, process impurities and degradation impurities. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can perfectly support various scenarios such as API registration and declaration, preparation quality research and routine release testing.