Isoniazid

As a core basic drug for anti-tuberculosis treatment, isoniazid is a synthetic anti-mycobacterial agent. It exerts a bactericidal effect by inhibiting the synthesis of mycolic acid in the cell wall of Mycobacterium tuberculosis and destroying the structural integrity of the bacteria, and has favorable antibacterial activity against Mycobacterium tuberculosis in both active proliferation and stationary phases inside and outside cells. It is a first-line drug recommended by global tuberculosis prevention and control guidelines. It can be used in combination with rifampicin, pyrazinamide and ethambutol for the initial and retreatment of various types of active tuberculosis, and can also be used as a prophylactic drug for latent tuberculosis infection in high-risk groups. The applicable population covers adults, children and tuberculosis patients co-infected with HIV.

The global anti-tuberculosis drug market size exceeded USD 4.8 billion in 2023. Among them, isoniazid, as a basic drug, has an annual demand of more than 8,000 tons stably, with a compound annual growth rate maintained at around 3.2%. China is the world's largest producer and exporter of isoniazid active pharmaceutical ingredients (APIs), with production capacity accounting for more than 75% of the global total capacity. The domestic market competition pattern is mature, and APIs produced by leading enterprises account for more than 80% of the total export volume. As this variety has been included in the National Essential Medicines List and the Class A Medical Insurance Catalog, the procurement demand of primary medical institutions is stable. Meanwhile, with the popularization of combination therapy regimens for multidrug-resistant tuberculosis, its market demand still maintains steady growth.

There is no definite original research enterprise for isoniazid. Currently, the isoniazid preparations marketed in China are mainly generic drugs, with dosage forms covering tablets, injections and creams. Among them, 0.1g tablets and 0.1g/1ml injections are commonly used clinical specifications, and preparations from multiple manufacturers have passed the consistency evaluation. As of July 2024, there are 32 entries of isoniazid APIs with registration status A publicly announced by the Center for Drug Evaluation (CDE) of the National Medical Products Administration. All domestic isoniazid preparations have been approved for marketing, and the reference preparations have been included in the *Catalog of Reference Preparations for Chemical Drugs*. (Data as of September 2024, please refer to the official CDE website for the latest information)

In response to the demand for quality research related to isoniazid, CATO can provide a full set of impurity reference standards for this API, covering all types of process impurities and degradation impurities. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia and FDA, and can meet the usage requirements of full scenarios such as API registration and declaration, quality control and stability study.