Rifabutin

For patients with AIDS complicated by Mycobacterium tuberculosis infection, the clinical application of traditional rifamycin drugs is often limited by problems such as hepatotoxicity and strong drug interactions. The advent of rifabutin has filled the treatment gap in this field. As a semi-synthetic rifamycin derivative, its mechanism of action is to inhibit the DNA-dependent RNA polymerase of Mycobacterium tuberculosis and block the synthesis of bacterial mRNA. Meanwhile, it also has good antibacterial activity against non-tuberculous mycobacteria and some Gram-positive bacteria. It is mainly used clinically for the treatment of multi-drug resistant tuberculosis, as well as the prevention and control of mycobacterial infections in patients with concurrent HIV infection, and is one of the core drugs for anti-tuberculosis treatment in immunocompromised populations.

The global rifabutin market size exceeded USD 180 million in 2023, with a compound annual growth rate maintained at around 7.2%. The growth momentum mainly comes from the increased demand for the prevention and control of multi-drug resistant tuberculosis and the continuous growth of HIV co-infection cases. In terms of the domestic market, only a small number of enterprises currently have the compliant production capacity for this API, and the overall supply concentration is relatively high. As this variety has been included in the medical insurance reimbursement catalogue for drug-resistant tuberculosis, the demand for downstream preparations has maintained an annual growth rate of more than 12% in recent years, and the supply and demand gap for APIs has existed for a long time.

The original research enterprise of rifabutin is Pharmacia Italia S.p.A of Italy, and the original brand name is Mycobutin. Its core compound patent expired globally in 2001, and the crystal form and dosage form patents in major markets also expired successively before 2010. The dosage form approved by the original research is capsules with a specification of 150mg, which has been included in the *Catalogue of Chemical Reference Preparations* of China and also included in the FDA reference preparation catalogue. Up to now, there are 6 rifabutin registration entries on the API registration platform of China CDE, among which 3 have been activated with A status, and the rifabutin capsules of multiple domestic enterprises have been approved for marketing. (Data as of November 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of rifabutin impurity reference standards. Most products 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 provide stable reference standard support for pharmaceutical enterprises in API R&D, quality research and consistency evaluation work.