Rifampicin

In the global tuberculosis prevention and control system, rifampicin is a widely recognized first-line core anti-tuberculosis drug, which belongs to the rifamycin class of semi-synthetic broad-spectrum antibacterial agents. Its mechanism of action is to specifically inhibit the DNA-dependent RNA polymerase of pathogens, thereby blocking the transcription and synthesis of bacterial mRNA. It has potent bactericidal activity against Mycobacterium tuberculosis, Mycobacterium leprae, and some non-tuberculous mycobacteria, and also has antibacterial effects against Gram-positive bacteria such as methicillin-sensitive Staphylococcus and Neisseria meningitidis. Clinically, it is mainly used for the initial treatment and retreatment of various types of tuberculosis, and can also be combined with other drugs for the treatment of leprosy and non-tuberculous mycobacterial infections. The applicable population covers adults and pediatric tuberculosis patients who meet the medication indications, and it is a basic drug recommended in the WHO Guidelines for Tuberculosis Prevention and Control.

According to public data, the global anti-tuberculosis drug market size was approximately USD 1.87 billion in 2023, among which rifampicin and its compound preparations accounted for more than 22%, making it the anti-tuberculosis drug with the highest market share as a single variety. In recent years, with the increasing demand for the prevention and control of drug-resistant tuberculosis, the annual compound growth rate of the rifampicin fixed-dose compound preparation market has remained at around 7%. For the domestic market, rifampicin has been included in the National Essential Medicines List and the Class A Medical Insurance Catalogue. At present, domestic generic preparations account for more than 95% of the overall market, and the supply of API is mainly from domestic manufacturers, with only a small number of high-end preparations using imported API, so the overall supply stability is relatively strong.

The original research enterprise of rifampicin is Sanofi, and the original brand name is Rifadin. The core compound patent of rifampicin expired globally in the 1980s. The main dosage forms approved for the original drug include oral capsules (150mg, 300mg), injection (600mg) and oral suspension. Among them, the 150mg and 300mg capsules and 600mg injection have been included in the FDA Reference Listed Drug Catalogue, and the above-mentioned original dosage forms are also included in the domestic Reference Listed Drug Catalogue. A variety of rifampicin preparations such as tablets, capsules, injections and eye drops have been approved for marketing in China. At present, more than 30 valid registration numbers of rifampicin API can be found on the CDE API registration platform, among which nearly 20 have obtained A status and can be used in association with domestic preparation declarations. (Data as of September 2024, please refer to the official CDE website for the latest information)

In response to the needs of rifampicin quality research and impurity control in the production process, CATO can provide a full set of impurity reference standards for this API. Most of the products are in stock, and in-stock products ordered before 16:00 can be shipped on the same day. All reference standards meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can directly support API registration and declaration, quality stability research and daily quality control testing scenarios.