- Raw materials
- Antibacterials
- Rifaximin
Filters
Filter
Custom request?
Type
Production region
Qualifications
Country of origin
Rifaximin API Manufacturers & Suppliers
11 verified results
Take control of your API sourcing
Submit a Special Inquiry and have Pharmaoffer activate verified suppliers.
Commercial-scale Suppliers
Distributor
Produced in
India|
Employees: 10
|
Audit Report:
Certifications:
GMP
|
FDA|
MSDS|
BSE/TSE|
CoAAll certificates
GMP
FDA
MSDS
BSE/TSE
CoA
Producer
Produced in
India|
Employees: 19
|
Audit Report:
Certifications:
GMP
|
FDA|
CoAAll certificates
GMP
FDA
CoA
Take control of your API sourcing
Submit a Special Inquiry and have Pharmaoffer activate verified suppliers.
Distributor
Produced in
China|
Employees: 50+
|
Audit Report:
Certifications:
GMP
|
CEP|
MSDS|
BSE/TSE|
ISO9001All certificates
GMP
CEP
MSDS
BSE/TSE
ISO9001
WC
CoA
Producer
Produced in
India|
Audit Report:
Certifications:
GMP
|
CoAAll certificates
GMP
CoA
Producer
Produced in
India|
Audit Report:
Certifications:
USDMF
|
CoAAll certificates
USDMF
CoA
Producer
Produced in
Unknown|
Audit Report:
Certifications:
GMP
|
USDMF|
CoAAll certificates
GMP
USDMF
CoA
Get full market intelligence report
€399,-
All Rifaximin data. Full access. Full negotiation power
Producer
Produced in
Japan|
Audit Report:
Certifications:
CoA
All certificates
CoA
Producer
Produced in
Unknown|
Audit Report:
Certifications:
GMP
|
USDMF|
JDMF|
CoAAll certificates
GMP
USDMF
JDMF
CoA
Take control of your API sourcing
Producer
Produced in
India|
Audit Report:
Certifications:
GMP
|
USDMF|
WC|
CoAAll certificates
GMP
USDMF
WC
CoA
Producer
Produced in
India|
Audit Report:
Certifications:
USDMF
|
CoAAll certificates
USDMF
CoA
Producer
Produced in
India|
Audit Report:
Certifications:
GMP
|
FDA|
CEP|
USDMF|
WCAll certificates
GMP
FDA
CEP
USDMF
WC
coa
When insight is your advantage
Full data, full access, full negotiation power
Total market transparency
|
Supplier trade data access
|
Buyer / supplier flow comparison
Trusted by 30,000+ registered pharma professionals:
Reach multinationals, SMEs, compounding pharmacies & more!
Rifaximin | CAS No: 80621-81-4 | GMP-certified suppliers
A medication that addresses travelers' diarrhea, helps reduce hepatic encephalopathy recurrence, and supports management of irritable bowel syndrome with diarrhea for gastrointestinal-focused therapeutic needs.
Therapeutic categories
Alimentary Tract and MetabolismAnti-Bacterial AgentsAnti-Infective AgentsAntibiotics for Topical UseAntidiarrheals, Intestinal Antiinflammatory/antiinfective AgentsCytochrome P-450 CYP2C19 Inducers
Generic name
Rifaximin
Molecule type
small molecule
CAS number
80621-81-4
DrugBank ID
DB01220
Approval status
Approved drug, Investigational drug
ATC code
A07AA11
Primary indications
- Rifaximin has multiple indications by the FDA: for the treatment of patients (≥12 years of age) with traveller's diarrhea caused by noninvasive strains of Escherichia coli
- For the reduction of overt hepatic encephalopathy recurrence in patients ≥18 years of age
- And in May 2015 it was approved for irritable bowel syndrome with diarrhea (IBS-D) treatment in adult men and women
Product Snapshot
- Rifaximin is available as oral and topical small‑molecule formulations including tablets, suspensions, and semi-solid forms
- It is used for traveler’s diarrhea caused by noninvasive E
- Coli, reduction of overt hepatic encephalopathy recurrence, and treatment of IBS‑D
Clinical Overview
Rifaximin (CAS 80621-81-4) is a semisynthetic rifamycin derivative classified as a macrolactam antibiotic. Its structural modification, including a pyridoimidazole moiety, produces minimal gastrointestinal absorption, enabling targeted intraluminal antimicrobial activity. The compound is approved for traveler’s diarrhea caused by noninvasive Escherichia coli in patients 12 years and older, reduction of overt hepatic encephalopathy recurrence in adults, and management of irritable bowel syndrome with diarrhea in adult men and women. It is marketed in several regions under the name Xifaxan.
Rifaximin exerts its antibacterial effect by binding to the beta subunit of the DNA‑dependent RNA polymerase in susceptible organisms, blocking translocation and interrupting transcription. This mechanism preserves activity within the gut lumen with limited systemic exposure. In addition to antimicrobial effects, rifaximin is a pregnane X receptor activator, a property relevant to modulation of intestinal inflammation and microbial composition in conditions such as IBS‑D.
Absorption after oral administration is minimal, with plasma concentrations generally low or undetectable in individuals with intact mucosa. Systemic bioavailability may increase in the presence of severe mucosal damage. The drug is largely eliminated unchanged in feces, reflecting negligible metabolism and limited renal clearance. Interactions related to cytochrome P450 induction are not clinically significant at standard oral exposures due to low systemic levels.
Safety data indicate predominantly gastrointestinal adverse effects, including abdominal pain and nausea. Rare hypersensitivity reactions have been reported. Because systemic exposure is low, toxicity outside the gastrointestinal tract is uncommon, although caution is advised in patients with significant intestinal inflammation or obstruction, which may increase absorption.
For API procurement, suppliers should provide evidence of identity, impurity control, and stability consistent with pharmacopeial or regionally accepted standards. Given its low‑solubility, poorly absorbed profile, attention to particle characterization and reproducible crystallinity is important for formulation performance and regulatory documentation.
Rifaximin exerts its antibacterial effect by binding to the beta subunit of the DNA‑dependent RNA polymerase in susceptible organisms, blocking translocation and interrupting transcription. This mechanism preserves activity within the gut lumen with limited systemic exposure. In addition to antimicrobial effects, rifaximin is a pregnane X receptor activator, a property relevant to modulation of intestinal inflammation and microbial composition in conditions such as IBS‑D.
Absorption after oral administration is minimal, with plasma concentrations generally low or undetectable in individuals with intact mucosa. Systemic bioavailability may increase in the presence of severe mucosal damage. The drug is largely eliminated unchanged in feces, reflecting negligible metabolism and limited renal clearance. Interactions related to cytochrome P450 induction are not clinically significant at standard oral exposures due to low systemic levels.
Safety data indicate predominantly gastrointestinal adverse effects, including abdominal pain and nausea. Rare hypersensitivity reactions have been reported. Because systemic exposure is low, toxicity outside the gastrointestinal tract is uncommon, although caution is advised in patients with significant intestinal inflammation or obstruction, which may increase absorption.
For API procurement, suppliers should provide evidence of identity, impurity control, and stability consistent with pharmacopeial or regionally accepted standards. Given its low‑solubility, poorly absorbed profile, attention to particle characterization and reproducible crystallinity is important for formulation performance and regulatory documentation.
Identification & chemistry
| Generic name | Rifaximin |
|---|---|
| Molecule type | Small molecule |
| CAS | 80621-81-4 |
| UNII | L36O5T016N |
| DrugBank ID | DB01220 |
Pharmacology
| Summary | Rifaximin is a non‑systemic antibiotic that targets the beta‑subunit of bacterial DNA‑dependent RNA polymerase, blocking transcription and suppressing RNA synthesis in susceptible gastrointestinal bacteria. Its minimal absorption keeps activity localized to the gut, where it helps modulate microbial balance. Rifaximin also activates the pregnane X receptor, contributing to downstream inhibition of NF‑κB–mediated inflammatory pathways. |
|---|---|
| Mechanism of action | Rifaximin acts by inhibiting RNA synthesis in susceptible bacteria by binding to the beta-subunit of bacterial deoxyribonucleic acid (DNA)-dependent ribonucleic acid (RNA) polymerase enzyme. This binding blocks translocation, which stops transcription. |
| Pharmacodynamics | Rifaximin is a structural analog of rifampin and a non-systemic, gastrointestinal site-specific antibiotic. This non-systemic property of the drug is due to the addition of a pyridoimidazole ring, which renders it non-absorbable. Rifaximin acts by inhibiting bacterial ribonucleic acid (RNA) synthesis and contributes to restore intestinal microflora imbalance. Other studies have also shown rifaximin to be an pregnane X receptor (PXR) activator. As PXR is responsible for inhibiting the proinflammatory transcription factor NF-kappa B (NF-κB) and is inhibited in inflammatory bowel disease (IBD), rifaximin was proven to be effective for the treatment of IBS-D. |
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 | Low absorption in both the fasting state and when administered within 30 minutes of a high-fat breakfast. |
|---|---|
| Half-life | Approximately 6 hours. |
| Metabolism | In vitro drug interactions studies have shown that rifaximin, at concentrations ranging from 2 to 200 ng/mL, did not inhibit human hepatic cytochrome P450 isoenzymes: 1A2, 2A6, 2B6, 2C9, 2C19, 2D6, 2E1, and 3A4. In an in vitro hepa-tocyte induction model, rifaximin was shown to induce cytochrome P450 3A4 (CYP3A4), an isoenzyme which rifampin is known to induce. |
| Route of elimination | In a mass balance study, after administration of 400 mg 14C-rifaximin orally to healthy volunteers, of the 96.94% total recovery, 96.62% of the administered radioactivity was recovered in feces almost exclusively as the unchanged drug and 0.32% was recovered in urine mostly as metabolites with 0.03% as the unchanged drug.Rifaximin accounted for 18% of radioactivity in plasma. This suggests that the absorbed rifaximin undergoes metabolism with minimal renal excretion of the unchanged drug |
Formulation & handling
- Oral formulations rely on its minimal GI absorption and very low aqueous solubility, requiring dispersion‑focused designs rather than systemic delivery enhancement.
- High lipophilicity and macrolactam structure make it sensitive to polymorphic and crystalline form control, with attention to particle size for consistent GI luminal exposure.
- Topical and oral products should protect the solid API from moisture to maintain stability and avoid degradation of the large, poorly soluble macrolactam scaffold.
Regulatory status
| Lifecycle | The API’s U.S. patent estate begins to expire in 2024, with remaining protection extending to 2029, indicating a transition from early loss of exclusivity toward later-stage maturity. With commercialization limited to the US and Canada, market dynamics will likely shift as the earliest patents lapse and generic entry becomes feasible. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Rifaximin is supplied by several packagers, while the branded product is associated with a single originator, indicating a centralized source of innovator manufacturing. Its commercial presence is established mainly in the US and Canada, with limited evidence of wider global branded distribution. Multiple key US patents have already expired or will do so by 2026, while one extends to 2029, suggesting that partial generic competition is possible in the near term, with broader entry constrained until final patent expiry. |
|---|
Safety
| Toxicity | LD<sub>50</sub> > 2 g/kg (orally, in rats) |
|---|
High Level Warnings:
- Low acute oral toxicity in animal models (rat LD50 ›2 g/kg), but dust generation should be minimized to limit occupational exposure
- May cause irritation with prolonged contact
- Use standard containment and protective equipment during weighing and milling
Rifaximin 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.
Rifaximin API manufacturers & distributors
Compare qualified Rifaximin API suppliers worldwide. We currently have 11 companies offering Rifaximin 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 |
|---|---|---|---|---|---|
| ACE Japan | Producer | Japan | Japan | CoA | 76 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, WC | 250 products |
| Cambrex | Producer | Italy | Unknown | CoA, GMP, USDMF | 104 products |
| Lupin | Producer | India | India | CoA, GMP, USDMF, WC | 155 products |
| MSN Labs. | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 119 products |
| Optrix Laboratories Priva... | Producer | India | India | CoA, GMP | 2 products |
| Raks Pharma | Producer | India | India | CoA, USDMF | 58 products |
| Sanofi | Producer | France | Unknown | CoA, GMP, JDMF, USDMF | 93 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Sun Pharma | Producer | India | India | CoA, USDMF | 219 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
When sending a request, specify which Rifaximin 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 Rifaximin 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 Rifaximin API
Sourcing
What matters most when sourcing GMP-grade Rifaximin?
When sourcing GMP‑grade Rifaximin, the key considerations are regulatory compliance for the US and Canada and verification that manufacturing aligns with the centralized originator source or qualified alternative suppliers. Ensuring documented GMP controls, complete traceability, and conformity with regional registration requirements is essential. Patent status should also be reviewed, as remaining protections through 2029 may influence supplier availability and permissible uses.
Which documents are typically required when sourcing Rifaximin API?
Request the core API documentation set: CoA (11 companies), GMP (8 companies), USDMF (6 companies), WC (3 companies), FDA (3 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Rifaximin API?
Known or reported manufacturers for Rifaximin: Aurora Industry Co., Ltd, SETV Global, Tenatra Exports Private Limited. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Rifaximin 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 Rifaximin manufacturers?
Audit reports may be requested for Rifaximin: 4 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Rifaximin API on Pharmaoffer?
Reported supplier count for Rifaximin: 11 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Rifaximin API?
Production countries reported for Rifaximin: India (7 producers), China (1 producer), Japan (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Rifaximin usually hold?
Common certifications for Rifaximin suppliers: CoA (11 companies), GMP (8 companies), USDMF (6 companies), WC (3 companies), FDA (3 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Rifaximin (CAS 80621-81-4) used for?
Rifaximin is used for traveler’s diarrhea caused by noninvasive Escherichia coli in patients 12 years and older. It is also indicated to reduce the recurrence of overt hepatic encephalopathy in adults and to manage irritable bowel syndrome with diarrhea in adults. Its clinical effects derive from intraluminal inhibition of bacterial RNA polymerase.
Which therapeutic class does Rifaximin fall into?
Rifaximin belongs to the following therapeutic categories: Alimentary Tract and Metabolism, Anti-Bacterial Agents, Anti-Infective Agents, Antibiotics for Topical Use, Antidiarrheals, Intestinal Antiinflammatory/antiinfective Agents. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Rifaximin mainly prescribed for?
The primary indications for Rifaximin: Rifaximin has multiple indications by the FDA: for the treatment of patients (≥12 years of age) with traveller's diarrhea caused by noninvasive strains of Escherichia coli, For the reduction of overt hepatic encephalopathy recurrence in patients ≥18 years of age, And in May 2015 it was approved for irritable bowel syndrome with diarrhea (IBS-D) treatment in adult men and women. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Rifaximin work?
Rifaximin acts by inhibiting RNA synthesis in susceptible bacteria by binding to the beta-subunit of bacterial deoxyribonucleic acid (DNA)-dependent ribonucleic acid (RNA) polymerase enzyme. This binding blocks translocation, which stops transcription.
What should someone know about the safety or toxicity profile of Rifaximin?
Rifaximin has low acute oral toxicity in animal models and is minimally absorbed, so systemic adverse effects are uncommon under normal gastrointestinal conditions. Reported reactions are mainly gastrointestinal, with rare hypersensitivity events. Increased absorption may occur with severe intestinal inflammation or obstruction, warranting caution. For API handling, dust generation should be minimized, and standard containment and protective equipment are recommended to prevent irritation and occupational exposure.
What are important formulation and handling considerations for Rifaximin as an API?
Rifaximin’s very low aqueous solubility and minimal systemic absorption require formulations that promote uniform dispersion in the gastrointestinal lumen rather than enhance permeability. Control of crystalline form and particle size is important because its lipophilic macrolactam structure can exhibit polymorphic variability. The API should be protected from moisture to maintain solid‑state stability and prevent degradation. These considerations apply to both oral and topical preparations.
Is Rifaximin a small molecule?
Rifaximin is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Rifaximin?
Oral Rifaximin requires protection from moisture to prevent degradation of its large, poorly soluble macrolactam structure. Its low aqueous solubility and high lipophilicity make control of crystalline or polymorphic form and particle size important for consistent dispersion in the gastrointestinal lumen. These factors, rather than systemic stability, are the primary stability considerations for oral products.
Regulatory
Where is Rifaximin approved or in use globally?
Rifaximin is reported as approved in the following major regions: US, Canada. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Rifaximin procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Rifaximin. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Rifaximin included in the PRO Data Insights coverage?
PRO Data Insights coverage for Rifaximin: 1602 verified transactions across 443 suppliers and 240 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Rifaximin?
Market report availability for Rifaximin: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
