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Rifapentine | CAS No: 61379-65-5 | GMP-certified suppliers
A medication that treats pulmonary tuberculosis, supporting reliable control of drug‑susceptible mycobacterial infections for manufacturers supplying standardized tuberculosis therapy programs.
Therapeutic categories
Anti-Bacterial AgentsAnti-Infective AgentsAntibiotics, AntitubercularAntiinfectives for Systemic UseAntimycobacterialsCytochrome P-450 CYP2B6 Inducers
Generic name
Rifapentine
Molecule type
small molecule
CAS number
61379-65-5
DrugBank ID
DB01201
Approval status
Approved drug, Investigational drug
ATC code
J04AB05
Primary indications
- For the treatment of pulmonary tuberculosis
Product Snapshot
- Rifapentine is an oral small‑molecule antibacterial API supplied as coated or film‑coated tablets
- It is used for pulmonary tuberculosis applications
- It holds US approval with additional investigational status in certain contexts
Clinical Overview
Rifapentine (CAS 61379-65-5) is a rifamycin-class antimycobacterial agent used in the treatment of pulmonary tuberculosis. It is a macrocyclic macrolactam structurally related to rifampin and other rifamycins, characterized by a large lactam ring with nitrogen substitution. Its clinical use is focused on drug‑susceptible Mycobacterium tuberculosis, including regimens that leverage its prolonged activity to support intermittent dosing schedules.
Rifapentine exerts its antimicrobial effect by binding to the beta subunit of bacterial DNA‑dependent RNA polymerase, blocking RNA synthesis and leading to bactericidal activity. It demonstrates activity against both extracellular and intracellular M. tuberculosis, with enhanced effects in macrophage environments. Activity against a broad range of gram‑positive and gram‑negative bacteria has been noted, but emergence of resistance limits its use primarily to mycobacterial infections.
Absorption following oral administration is adequate, and the compound distributes widely into tissues. Available information indicates hepatic metabolism with predominant biliary elimination, consistent with the rifamycin class. Renal excretion is limited, and dose adjustments for renal impairment are generally not required. Rifapentine is a substrate and potent inducer of multiple cytochrome P450 enzymes, including CYP3A, CYP2C8, CYP2C9, and CYP2C19. These induction effects create a high potential for drug–drug interactions with concomitant medications metabolized through these pathways.
Safety considerations include hepatotoxicity, hypersensitivity reactions, and discoloration of body fluids. Enzyme induction can reduce the exposure of many co‑administered drugs, necessitating careful regimen review in patients receiving antiretrovirals, immunosuppressants, or other CYP‑metabolized therapies. Resistance may emerge with inadequate dosing or poor adherence, reinforcing the need for combination therapy.
In global markets, rifapentine is available in several branded formulations used within standardized tuberculosis treatment programs. For API procurement, suppliers should demonstrate consistent impurity control, validated potency assays, and conformity with pharmacopeial or regulatory specifications to support robust finished‑product manufacturing and regulatory submissions.
Rifapentine exerts its antimicrobial effect by binding to the beta subunit of bacterial DNA‑dependent RNA polymerase, blocking RNA synthesis and leading to bactericidal activity. It demonstrates activity against both extracellular and intracellular M. tuberculosis, with enhanced effects in macrophage environments. Activity against a broad range of gram‑positive and gram‑negative bacteria has been noted, but emergence of resistance limits its use primarily to mycobacterial infections.
Absorption following oral administration is adequate, and the compound distributes widely into tissues. Available information indicates hepatic metabolism with predominant biliary elimination, consistent with the rifamycin class. Renal excretion is limited, and dose adjustments for renal impairment are generally not required. Rifapentine is a substrate and potent inducer of multiple cytochrome P450 enzymes, including CYP3A, CYP2C8, CYP2C9, and CYP2C19. These induction effects create a high potential for drug–drug interactions with concomitant medications metabolized through these pathways.
Safety considerations include hepatotoxicity, hypersensitivity reactions, and discoloration of body fluids. Enzyme induction can reduce the exposure of many co‑administered drugs, necessitating careful regimen review in patients receiving antiretrovirals, immunosuppressants, or other CYP‑metabolized therapies. Resistance may emerge with inadequate dosing or poor adherence, reinforcing the need for combination therapy.
In global markets, rifapentine is available in several branded formulations used within standardized tuberculosis treatment programs. For API procurement, suppliers should demonstrate consistent impurity control, validated potency assays, and conformity with pharmacopeial or regulatory specifications to support robust finished‑product manufacturing and regulatory submissions.
Identification & chemistry
| Generic name | Rifapentine |
|---|---|
| Molecule type | Small molecule |
| CAS | 61379-65-5 |
| UNII | XJM390A33U |
| DrugBank ID | DB01201 |
Pharmacology
| Summary | Rifapentine inhibits the bacterial DNA‑dependent RNA polymerase, suppressing RNA synthesis and leading to bactericidal activity against Mycobacterium tuberculosis. Its activity extends to intracellular organisms, reflecting effective penetration into macrophages where mycobacteria reside. Therapeutic use is focused on pulmonary tuberculosis due to resistance concerns despite its broad antibacterial spectrum. |
|---|---|
| Mechanism of action | Rifapentine has shown higher bacteriostatic and bactericidal activities especially against intracellular bacteria growing in human monocyte-derived macrophages. Rifapentine inhibits DNA-dependent RNA polymerase in susceptible strains of M. tuberculosis. Rifapentine acts via the inhibition of DNA-dependent RNA polymerase, leading to a suppression of RNA synthesis and cell death. |
| Pharmacodynamics | Rifapentine 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 Pseudomonas aeruginosa) and specifically Mycobacterium tuberculosis. 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' | Mycobacterium tuberculosis | inhibitor |
ADME / PK
| Absorption | Rapidly and well absorbed from the gastrointestinal tract. |
|---|---|
| Protein binding | 97.7% (bound to plasma proteins) |
| Metabolism | Hepatic |
| Route of elimination | Following a single 600 mg oral dose of radiolabeled rifapentine to healthy volunteers (n=4), 87% of the total 14C rifapentine was recovered in the urine (17%) and feces (70%). |
| Volume of distribution | * 70.2 ± 9.1 L |
| Clearance | * Apparent Oral cl=2.51 +/- 0.14 L/h [Male tuberculosis patients who received 600 mg rifapentine in combination with isoniazid, pyrazinamide and ethambutol] * Apparent Oral cl=1.69 +/- 0.41 L/h [Female tuberculosis patients who received 600 mg rifapentine in combination with isoniazid, pyrazinamide and ethambutol] |
Formulation & handling
- Low aqueous solubility and high molecular weight support formulation as coated oral tablets, often requiring solubilizers to enhance dissolution.
- Bioavailability increases with food, so oral products may be designed to accommodate fed‑state administration and minimize GI variability.
- Solid-state stability of this macrolactam should be monitored for moisture sensitivity, and tablets may need protective coatings to maintain potency during storage.
Regulatory status
| Lifecycle | The API is marketed in the United States, where primary patent protection has lapsed, indicating a mature market with established generic availability. Lifecycle prospects are stable, with limited expectation for further exclusivity-driven shifts. |
|---|
| Markets | US |
|---|
Supply Chain
| Supply chain summary | Rifapentine appears to have a limited originator base, with packaging linked to two companies and branded supply centered on the Priftin product. Current market presence is primarily in the United States, with no evidence of broader EU or global branded distribution in the provided data. The molecule is long off‑patent, indicating that generic competition is already feasible where regulatory pathways and demand support it. |
|---|
Rifapentine 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.
Rifapentine API manufacturers & distributors
Compare qualified Rifapentine API suppliers worldwide. We currently have 2 companies offering Rifapentine API, with manufacturing taking place in 2 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 |
|---|---|---|---|---|---|
| ACE Japan | Producer | Japan | Japan | CoA | 76 products |
| Sanofi | Producer | France | France | CoA, GMP | 93 products |
When sending a request, specify which Rifapentine 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 Rifapentine 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 Rifapentine API
Sourcing
What matters most when sourcing GMP-grade Rifapentine?
Key considerations include ensuring full compliance with US GMP and meeting all FDA regulatory and documentation requirements. Because Rifapentine has a limited originator and packaging base, verifying the supplier’s manufacturing capacity and supply continuity is essential. It is also important to confirm the API’s suitability for generic pathways, as the molecule is long off‑patent.
Which documents are typically required when sourcing Rifapentine API?
Request the core API documentation set: CoA (2 companies), GMP (1 company). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Rifapentine API?
Known or reported manufacturers for Rifapentine: . Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Rifapentine API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Rifapentine manufacturers?
Audit reports may be requested for Rifapentine: 1 GMP audit report available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Rifapentine API on Pharmaoffer?
Reported supplier count for Rifapentine: 2 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Rifapentine API?
Production countries reported for Rifapentine: Japan (1 producer), France (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Rifapentine usually hold?
Common certifications for Rifapentine suppliers: CoA (2 companies), GMP (1 company). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Rifapentine (CAS 61379-65-5) used for?
Rifapentine is used to treat drug‑susceptible pulmonary tuberculosis. It targets Mycobacterium tuberculosis by inhibiting the beta subunit of DNA‑dependent RNA polymerase, blocking RNA synthesis and producing bactericidal activity. Its prolonged activity supports use in combination regimens, including intermittent dosing schedules.
Which therapeutic class does Rifapentine fall into?
Rifapentine belongs to the following therapeutic categories: Anti-Bacterial Agents, Anti-Infective Agents, Antibiotics, Antitubercular, Antiinfectives for Systemic Use, Antimycobacterials. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Rifapentine mainly prescribed for?
The primary indications for Rifapentine: For the treatment of pulmonary tuberculosis. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Rifapentine work?
Rifapentine has shown higher bacteriostatic and bactericidal activities especially against intracellular bacteria growing in human monocyte-derived macrophages. Rifapentine inhibits DNA-dependent RNA polymerase in susceptible strains of M. tuberculosis. Rifapentine acts via the inhibition of DNA-dependent RNA polymerase, leading to a suppression of RNA synthesis and cell death.
What should someone know about the safety or toxicity profile of Rifapentine?
Rifapentine’s safety profile includes risks typical of rifamycins, such as hepatotoxicity and hypersensitivity reactions. It can cause discoloration of body fluids and is a potent inducer of multiple CYP450 enzymes, which may lower exposure to co‑administered drugs. Limited renal elimination means dose adjustment in renal impairment is generally unnecessary, but careful review of interacting medications is important. Resistance can develop with inadequate dosing or poor adherence, supporting use in combination regimens.
What are important formulation and handling considerations for Rifapentine as an API?
Rifapentine’s low aqueous solubility and relatively high molecular weight support its use in coated oral tablets, often with solubilizers to improve dissolution. Because bioavailability increases with food, formulations may be designed to reduce variability between fed and fasted states. The macrolactam structure warrants monitoring for moisture sensitivity, and protective coatings can help maintain solid‑state stability during storage and handling.
Is Rifapentine a small molecule?
Rifapentine is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Rifapentine?
Oral Rifapentine has stability considerations related to its low aqueous solubility and moisture sensitivity. Solid‑state stability should be monitored, and protective tablet coatings may be needed to maintain potency during storage. Formulations often include solubilizers to support dissolution, and products may be designed to accommodate administration with food to reduce variability in bioavailability.
Regulatory
Where is Rifapentine approved or in use globally?
Rifapentine is reported as approved in the following major regions: US. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Rifapentine right now?
Rifapentine is an FDA‑approved drug in the United States. Its protection and exclusivity are managed under standard US regulatory and patent frameworks that govern small‑molecule pharmaceuticals.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Rifapentine procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Rifapentine. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Rifapentine included in the PRO Data Insights coverage?
PRO Data Insights coverage for Rifapentine: 106 verified transactions across 42 suppliers and 37 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Rifapentine?
Market report availability for Rifapentine: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
