Rifampicin API Manufacturers & Suppliers

Rifampicin (CAS 13292-46-1) is a semisynthetic rifamycin antibiotic derived from Streptomyces mediterranei. It is indicated for the treatment of tuberculosis and related mycobacterial infections and is a core component of standard short-course regimens when combined with isoniazid and pyrazinamide. Its clinical role is anchored in its bactericidal activity against Mycobacterium tuberculosis and other susceptible mycobacteria.

Rifampicin inhibits bacterial DNA‑dependent RNA polymerase by forming a stable complex with the enzyme, blocking the initiation of RNA synthesis. This selective interaction does not affect mammalian polymerases. The result is rapid suppression of transcription and cell death in both intracellular and extracellular organisms. Its broad antibacterial spectrum includes many gram-positive and gram-negative pathogens, although resistance develops readily, limiting its use mainly to mycobacterial disease and a few defined indications.

Following oral administration, rifampicin is well absorbed and achieves extensive tissue distribution, including penetration into cerebrospinal fluid. It undergoes hepatic metabolism and is excreted primarily in bile with minor renal elimination. Renal impairment generally does not require dose adjustment. Rifampicin is a potent inducer of multiple drug‑metabolizing enzymes and transporters, including several CYP450 isoforms, UGT enzymes, and efflux transporters such as P‑glycoprotein. These properties contribute to extensive drug interaction potential.

Key safety considerations include hepatotoxicity risk, particularly when used in multidrug regimens or in patients with preexisting liver dysfunction. Orange discoloration of bodily fluids is common and benign. Hypersensitivity reactions and hematologic abnormalities may also occur. Clinically significant interactions with drugs metabolized by CYP3A, CYP2C, CYP2B6, or CYP1A2 are well documented and require careful management.

Rifampicin is widely known under global brand names such as Rifadin and Rimactane for clinical use.

For API procurement, sourcing should ensure control of polymorphic form, residual solvents, and stability under light and humidity. Compliance with pharmacopeial specifications and verification of consistent impurity profiles is essential for formulation and regulatory workflows.