Pyrazinamide

As a core first-line drug for anti-tuberculosis treatment, pyrazinamide belongs to the nicotinamide class of anti-mycobacterial agents. Its unique mechanism of action is that it is converted into the active form pyrazinoic acid by the pyrazinamidase of Mycobacterium tuberculosis itself, which precisely disrupts the membrane transport and energy metabolism processes in the acidic environment of the bacteria, thereby killing the semi-dormant persistent Mycobacterium tuberculosis in the acidic environment. At present, this drug is mainly combined with isoniazid, rifampicin and ethambutol to form a standard chemotherapy regimen, which is used in the initial and retreatment stages of various types of tuberculosis, especially suitable for the whole-course treatment of extrapulmonary tuberculosis such as tuberculous meningitis and osteoarticular tuberculosis, covering the full-course medication needs of adult and child tuberculosis infected persons.

The current global anti-tuberculosis drug market size has exceeded 3 billion US dollars, among which pyrazinamide, as a basic drug, accounts for about 6%, and the compound annual growth rate is maintained at around 3.8%. China is the largest supplier of pyrazinamide API in the world, with its production capacity accounting for more than 75% of the global total production capacity. The domestic market competition presents a pattern of head concentration, and the total market share of the top 3 manufacturers exceeds 60%. As the number of global multidrug-resistant tuberculosis cases increases year by year, the promotion of short-course multidrug-resistant treatment regimens containing pyrazinamide further drives the growth of demand. Coupled with the improvement of the domestic tuberculosis prevention and control system leading to the increase of the penetration rate of primary-level medication, the demand for this API is expected to maintain a stable growth rate of more than 4% in the next 3 years.

The original research enterprise of pyrazinamide is Pfizer Inc. of the United States, with the original trade name Pyrazinamide, and the core compound patent expired globally in 1973. The currently marketed dosage forms of the original product include tablets and suspensions. The common specification of tablets is 500mg, and the specification of suspension is 100mg/5mL. The original product has been included in the FDA Reference Listed Drug Catalog, and is also included in the *Catalog of Reference Listed Drugs of Chemicals of China. Up to now, more than 20 domestic enterprises have obtained Class A status for their pyrazinamide APIs through CDE registration, and more than 30 enterprises have obtained marketing approval for pyrazinamide tablets and pyrazinamide capsule preparations. (Data as of November 2024, please refer to the official website of CDE for the latest information.

CATO can provide a full set of pyrazinamide impurity reference standards, which fully meet the needs of full-scenario requirements such as generic drug consistency evaluation, quality research, release testing, etc. Most of the products are in stock. In-stock products ordered before 16:00 will be shipped on the same day. They fully comply with the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and provide stable and reliable supply chain support for quality control in R&D and production links.