Rifamycin

In the clinical treatment of drug-resistant bacterial infections, rifamycin antibiotics have always been the core component of anti-tuberculosis regimens. As ansamycin broad-spectrum antibacterial agents, their mechanism of action is to specifically bind to the β subunit of bacterial DNA-dependent RNA polymerase and block the mRNA transcription process, thereby inhibiting bacterial protein synthesis. In addition to being first-line drugs for *Mycobacterium tuberculosis* infection, rifamycins have strong activity against a variety of Gram-positive and Gram-negative pathogenic bacteria such as *Mycobacterium leprae*, *Staphylococcus aureus* and Legionella, and are widely applicable to the combination treatment regimens for patients with active tuberculosis, leprosy, severe infections caused by drug-resistant bacteria, etc.

The global market size of rifamycin drugs has maintained a steady growth trend in recent years. In 2023, the market size was approximately USD 1.87 billion, with a compound annual growth rate of around 4.2%. Market demand is concentrated in countries with a high burden of tuberculosis, among which Southeast Asian countries such as China and India account for more than 60% of the total consumption. In terms of the competitive landscape, generic drugs dominate the market. Relying on technological iteration and cost advantages, domestic API manufacturers have become the core suppliers of rifamycin APIs in the world, with domestic output accounting for more than 75% of the total global output. As many countries have included rifamycin preparations in their public health procurement catalogs, the stability of downstream market demand continues to improve.

The original developer of rifamycin is the Italian pharmaceutical company Lepetit S.p.A, and the original brand name is Rifocin. The core compound patent has expired globally in the 1960s. At present, the main dosage forms approved worldwide include injections, oral capsules and topical ointments, among which the common specifications of injections are 0.25g/5ml and 0.5g/10ml. The original injection has been included in the FDA Orange Book Reference Listed Drug Catalog, and relevant dosage forms have also been included in the *Catalog of Reference Listed Drugs for Chemical Drugs* in China. Up to now, there are 11 valid registration numbers for rifamycin APIs on the API registration platform of China CDE, among which 8 are in status A, which can be used in association with domestic preparation declaration. A number of rifamycin injections and oral preparations have been approved for marketing in China. (Data as of July 2025, please refer to the official CDE website for the latest information)

For customers with needs for R&D and quality control of rifamycin-related preparations, CATO can provide a full set of impurity reference standards for this API. Most products are in stock, in-stock products ordered before 16:00 will be shipped on the same day, and the products comply with the regulatory requirements of Chinese Pharmacopoeia and FDA, which can provide stable material basis support for enterprises' impurity research, quality standard establishment and registration declaration work.