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Rifampicin | CAS No: 13292-46-1 | GMP-certified suppliers
A medication that supports treatment of tuberculosis and related mycobacterial infections, providing reliable coverage for standard regimens required in global respiratory infectious‑disease programs.
Therapeutic categories
Primary indications
- Rifampin is indicated for the treatment of tuberculosis and tuberculosis-related mycobacterial infections
- In combination with pyrazinamide and isoniazid, it is used in the initial phase of the short-course treatment of pulmonary tuberculosis
Product Snapshot
- Rifampicin is an oral and parenteral small-molecule antibacterial API available in multiple solid, liquid, and injectable presentations
- It is used for tuberculosis and other mycobacterial infections as part of combination regimens
- It is approved in major regulated markets including the US and Canada
Clinical Overview
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.
Identification & chemistry
| Generic name | Rifampicin |
|---|---|
| Molecule type | Small molecule |
| CAS | 13292-46-1 |
| UNII | VJT6J7R4TR |
| DrugBank ID | DB01045 |
Pharmacology
| Summary | Rifampin inhibits bacterial DNA‑dependent RNA polymerase, blocking RNA synthesis and producing bactericidal activity. Its pharmacology is characterized by broad activity against gram‑positive and gram‑negative organisms, with key relevance for *Mycobacterium tuberculosis*. Primary targets include the RNA polymerase beta subunit and the nuclear receptor NR1I2, supporting its role in treating tuberculosis and related mycobacterial infections. |
|---|---|
| Mechanism of action | Rifampin acts via the inhibition of DNA-dependent RNA polymerase, leading to a suppression of RNA synthesis and cell death. |
| Pharmacodynamics | Rifampin is an antibiotic that inhibits DNA-dependent RNA polymerase activity in susceptible cells. Specifically, it interacts with bacterial RNA polymerase but does not inhibit the mammalian enzyme. It is bactericidal and has a very broad spectrum of activity against most gram-positive and gram-negative organisms (including <i>Pseudomonas aeruginosa</i>) and specifically <i>Mycobacterium tuberculosis</i>. Because of rapid emergence of resistant bacteria, use is restricted to treatment of mycobacterial infections and a few other indications. Rifampin is well absorbed when taken orally and is distributed widely in body tissues and fluids, including the CSF. It is metabolized in the liver and eliminated in bile and, to a much lesser extent, in urine, but dose adjustments are unnecessary with renal insufficiency. |
Targets
| Target | Organism | Actions |
|---|---|---|
| DNA-directed RNA polymerase subunit beta | Escherichia coli (strain K12) | inhibitor |
| Nuclear receptor subfamily 1 group I member 2 | Humans | agonist |
ADME / PK
| Absorption | Well absorbed from gastrointestinal tract. |
|---|---|
| Half-life | 3.35 (+/- 0.66) hours |
| Protein binding | 89% |
| Metabolism | Primarily hepatic, rapidly deacetylated. |
| Route of elimination | Less than 30% of the dose is excreted in the urine as rifampin or metabolites. |
| Clearance | * 0.19 +/- 0.06 L/hr/kg [300 mg IV] * 0.14 +/- 0.03 L/hr/kg [600 mg IV] |
Formulation & handling
- Oral formulations must account for very low aqueous solubility and are typically administered on an empty stomach due to food‑related reductions in absorption.
- IV products rely on lyophilized powder that requires careful reconstitution and protection from light to maintain stability.
- The bulky macrolactam structure yields a high‑molecular‑weight small molecule with limited solubility, driving the need for solubilizers or dispersion strategies in oral liquids and suspensions.
Regulatory status
| Lifecycle | The API is in a mature phase of its lifecycle, with patent expiry enabling broader generic presence in the US and Canada. Market dynamics are now driven primarily by established competition and routine demand. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Rifampicin’s supply landscape is dominated by numerous manufacturers and repackagers, reflecting a mature market long past originator patent protection. Branded products such as Rifadin and combination formulations like IsonaRif have established global use, including presence in the US, EU, and other regions. Patent expiry decades ago has enabled broad generic competition, with extensive distribution in North American markets. |
|---|
Safety
| Toxicity | LD<sub>50</sub>=1570 mg/kg (rat), chronic exposure may cause nausea and vomiting and unconsciousness |
|---|
- Oral LD50 in rats is approximately 1570 mg/kg, indicating moderate acute toxicity
- Avoid inhalation or dermal exposure to concentrated material
- Chronic occupational exposure has been associated with nausea, vomiting, and CNS depression progressing to unconsciousness
Certificate of Analysis
A CoA is a document issued by a companies’ QA/QC-department that confirms that a product meets its product specification and is part of the quality control of a product batch. The CoA commonly contains results obtained from laboratory tests of an individual batch of a product. There are different international standards to which a product can be tested, for example: Ph. Eur. | EP – (European Pharmacopoeia) USP – (United States Pharmacopeia)
Rifampicin is a type of Antibacterials
Antibacterials, a category of pharmaceutical active pharmaceutical ingredients (APIs), play a crucial role in combating bacterial infections. These APIs are chemical compounds that target and inhibit the growth or kill bacteria, helping to eliminate harmful bacterial pathogens from the body.
Antibacterials are essential for the treatment of various bacterial infections, including respiratory tract infections, urinary tract infections, skin and soft tissue infections, and more. They are commonly prescribed by healthcare professionals to combat both mild and severe bacterial infections.
Within the category of antibacterials, there are different classes and subclasses of APIs, each with distinct mechanisms of action and target bacteria. Some commonly used antibacterials include penicillins, cephalosporins, tetracyclines, macrolides, and fluoroquinolones. These APIs work by interfering with various aspects of bacterial cellular processes, such as cell wall synthesis, protein synthesis, DNA replication, or enzyme activity.
The development and production of antibacterial APIs require stringent quality control measures to ensure their safety, efficacy, and purity. Pharmaceutical manufacturers must adhere to Good Manufacturing Practices (GMP) and follow rigorous testing protocols to guarantee the quality and consistency of these APIs.
As bacterial resistance to antibiotics continues to be a significant concern, ongoing research and development efforts aim to discover and develop new antibacterial APIs. The evolution of antibacterials plays a crucial role in combating emerging bacterial strains and ensuring effective treatment options for infectious diseases.
In summary, antibacterials are a vital category of pharmaceutical APIs used to treat bacterial infections. They are designed to inhibit or kill bacteria, and their development requires strict adherence to quality control standards. By continually advancing research in this field, scientists and pharmaceutical companies can contribute to the ongoing battle against bacterial infections.
Rifampicin API manufacturers & distributors
Compare qualified Rifampicin API suppliers worldwide. We currently have 9 companies offering Rifampicin API, with manufacturing taking place in 4 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Arshine Pharmaceutical Co... | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, MSDS, USDMF | 176 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WC | 250 products |
| CKD Bio | Producer | South Korea | South Korea | CoA, GMP, USDMF | 12 products |
| Hebei Vistar Bio-Technolo... | Distributor | China | China | CoA, GMP | 3 products |
| Lupin | Producer | India | India | CoA, GMP, USDMF, WC | 155 products |
| Sandoz | Producer | Austria | India | CEP, CoA, FDA, GMP, WC | 58 products |
| Sanofi | Producer | France | Unknown | CoA, GMP, JDMF, USDMF | 93 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
When sending a request, specify which Rifampicin API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Rifampicin API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Rifampicin API
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Technical
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Regulatory
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