Ethambutol

Prevention and control of drug-resistant tuberculosis has long been a key challenge in the global public health field, and the standardized use of first-line anti-tuberculosis drugs is the core support for reducing the risk of drug resistance. As a first-line synthetic bacteriostatic agent against Mycobacterium tuberculosis, ethambutol inhibits the activity of arabinosyltransferase in Mycobacterium tuberculosis and interferes with the synthesis of arabinogalactan in the cell wall, thereby specifically inhibiting the proliferation of mycobacteria. It is often clinically combined with isoniazid, rifampicin and pyrazinamide for the treatment of various types of active tuberculosis, and can also be used for the intervention of atypical Mycobacterium tuberculosis infections. The applicable population covers newly treated, retreated and drug-resistant tuberculosis patients, and it is a basic component drug in the short-course chemotherapy regimen for tuberculosis.

The global anti-tuberculosis drug market size has exceeded US$4.5 billion in 2023, among which first-line anti-tuberculosis drugs account for more than 60%, and the compound annual growth rate is maintained at around 4.7%. As a basic medication, the annual global demand for ethambutol is stable at more than 1,800 tons. China is the main supplier of its active pharmaceutical ingredient (API), with a production capacity accounting for more than 75% of the global total. In terms of the domestic market, there are currently more than 20 enterprises holding production approvals for ethambutol API, with sufficient market competition and a stable price system. It has been included in the National Essential Medicines List and the Class A Medical Insurance List, with a coverage rate of more than 90% in medical institutions.

The original research enterprise of ethambutol is Lederle Laboratories in the United States, with the original brand name Myambutol, and the core compound patent expired globally in 1970. The main dosage forms approved for the original product are tablets with specifications of 100mg and 400mg, which have been included in the FDA Orange Book Reference Listed Drug Catalog, and also included in China's *Catalog of Reference Preparations for Chemical Drugs*. At present, 12 domestic enterprises have completed the registration of ethambutol API in CDE and obtained the A status label, and the approved preparation dosage forms include tablets, capsules, hydrochloride injections, etc. The supply can fully cover the domestic clinical demand. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of ethambutol impurity reference standards, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully support the use needs of different scenarios such as API R&D, quality research and routine quality control testing.