Rifaximin, Indian WHO-GMP tablet supply for hepatic encephalopathy maintenance and travellers' diarrhoea.
A non-absorbed rifamycin, under 0.4% oral bioavailability, acting locally in the gut rather than systemically. 200mg and 400mg tablets from Indian WHO-GMP manufacturing partners, 39 branded lines on the roster. The flagship use is chronic, maintenance therapy against hepatic encephalopathy recurrence, a repeat-order line rather than a one-off course.
39 branded lines · 200mg and 400mg tablets · under 0.4% systemic absorption · hepatic encephalopathy maintenance and travellers' diarrhoea.
Active ingredient
Rifaximin, a semi-synthetic rifamycin that binds the beta-subunit of bacterial DNA-dependent RNA polymerase and blocks transcription, structurally related to rifampicin but formulated for negligible systemic uptake. Oral bioavailability is under 0.4%, so it works almost entirely within the gut lumen rather than the bloodstream, the defining feature of everything else on this page.
Strengths stocked
200mg and 400mg tablets are the lines on the M Care roster, 39 branded generic lines in total, supplied under Indian reference brands including Rifakem, Rcifax, Torfix and Sibofix. This is a different strength range from the originator 550mg product (Xifaxan in the US, Targaxan in the UK); dosing pattern and frequency should be confirmed against the destination label rather than assumed from the originator regimen.
Indications
Reduction in risk of hepatic encephalopathy recurrence, maintenance therapy typically alongside lactulose, licensed in both the US (Xifaxan) and UK (Targaxan). Travellers' diarrhoea caused by non-invasive E. coli, a short defined course, separately licensed in the UK under the Xifaxanta brand. Irritable bowel syndrome with diarrhoea is a US-licensed indication; check destination labelling before quoting it into a tender.
Storage
Room temperature, 20-25°C, with excursions permitted 15-30°C. Tablet formulation, no reconstitution, no cold-chain requirement in transit. A standard ambient dispatch lane throughout.
Shelf life
Typically around 24 to 36 months from manufacture, depending on the manufacturing partner; refer to the specific product's label and CoA for the exact figure. Minimum 24 months remaining at dispatch, or we do not ship it.
Pack format
Alu-Alu or Alu-PVC blister, hospital and retail packs. Outer carton and leaflet in the destination-regulator language, carrying the rifamycin cross-hypersensitivity caution and the hepatic-impairment exposure note prominently, given that severe liver disease is exactly the population most likely to be prescribed this for encephalopathy.
Hepatology units, travel-medicine desks and gastroenterology formularies across the export markets.
India is our origin. We do not sell into the Indian market. Rifaximin is exported only.
United Kingdom
Rifaximin is stocked in NHS and private hepatology and gastroenterology services as Targaxan, licensed specifically for reduction of overt hepatic encephalopathy recurrence in adults, and separately as Xifaxanta for travellers' diarrhoea. Where the primary licensed supplier cannot fill, the MHRA Specials / named-patient import route is available, see MHRA Specials.
GCC (UAE, KSA, Kuwait, Oman, Qatar, Bahrain)
Through local licensed importers, chiefly into private and semi-private hospital hepatology and gastroenterology formularies rather than mass public-sector tenders (this is not a WHO Prequalification or Global Fund commodity), plus travel-medicine clinics serving the region's large expatriate population. SFDA, MoHAP and GCC central registration supported with a full CTD dossier.
Nigeria, Kenya, Ghana, South Africa, Ethiopia, Tanzania, Uganda, Rwanda
Teaching-hospital hepatology units, where the regional burden of viral-hepatitis-driven cirrhosis makes hepatic encephalopathy a real, recurring problem, plus travel-clinic and expatriate-medical-centre demand for travellers' diarrhoea cover. Private and tertiary-care procurement, not the WHO EML public-health tender channel our antibacterial lines move through.
Germany, France, Brazil, Mexico, Philippines
Supply via licensed importers under section 72 AMG (Germany), the ANSM-equivalent route (France), ANVISA (Brazil), COFEPRIS (Mexico) and FDA Philippines, into hepatology, gastroenterology and travel-medicine channels. CTD dossier and CoPP prepared for BfArM, ANSM, ANVISA, COFEPRIS and FDA Philippines recognition.
Minimal absorption, one real interaction, and why liver disease itself changes the exposure.
Rifaximin's clinical logic rests on what it doesn't do: at under 0.4% oral bioavailability, it barely reaches the bloodstream, so it cannot be used for systemic or invasive infection and does not carry the interaction burden of an absorbed antibiotic. The one exception worth flagging is P-glycoprotein: potent P-gp inhibitors, ciclosporin most notably, have been shown to raise rifaximin exposure many-fold, so that combination is not routine. Hepatic encephalopathy maintenance dosing is chronic, not a course, typically alongside lactulose, which is why this line behaves more like a repeat-prescription commodity than a burst tender item; travellers' diarrhoea dosing, by contrast, is a short defined course. Cross-hypersensitivity to other rifamycins, including rifampicin, is a contraindication worth screening for before initiating. In Child-Pugh C hepatic impairment, systemic exposure to rifaximin rises substantially even though absorption stays low in absolute terms, so severe liver disease, the population most likely to be prescribed it for encephalopathy, is exactly where dose-adjusted caution is documented on the label. No cold-chain requirement; ambient, room-temperature transit throughout.
The documentation pack a regulator actually asks for.
Rifaximin is not a WHO Essential Medicines List or WHO Prequalification molecule; its documentation pack runs through FDA-equivalent and MHRA/EMC-style dossiers rather than WHO tender qualification. M Care is the merchant-exporter, not the manufacturer: our own ISO 9001:2015 quality-management certification covers sourcing, documentation and export operations, while WHO-GMP status belongs to the manufacturing partner named on your quote.
CTD Module 3
Full chemistry, manufacturing and controls section, prepared in eCTD-ready format where the importing authority accepts it, with the Module 2 quality overall summary. Indication-specific labelling (hepatic encephalopathy maintenance versus travellers' diarrhoea versus IBS-D where licensed) mapped explicitly, since destination licences do not always cover all three.
CoA and MoA, per batch
HPLC assay, related substances per Ph.Eur./USP, water content by Karl Fischer, residual solvents per ICH Q3C, dissolution profile and microbial limits, signed by the manufacturing partner's authorised QC head. Because rifaximin's mechanism depends on staying local to the gut, dissolution and disintegration data get particular attention in our release checks.
CoPP, WHO-GMP, MFG licence
Issued by CDSCO (Central Drugs Standard Control Organization, India) and apostilled where the destination requires it, with the manufacturing partner's WHO-GMP certificate. Notarised copies travel in the shipping pack. We do not claim WHO Prequalification for rifaximin; it is not a molecule WHO-PQ currently lists.
Pack insert, labels, artwork
Destination-language PIL and labelling to local standards. The rifamycin cross-hypersensitivity caution (patients sensitive to rifampicin or other rifamycins should not take rifaximin) and the Child-Pugh C hepatic-impairment exposure note are set on the insert. Artwork QC before print, not after.
Temperature control
Pre-shipment validation per shipper configuration. Tablets ship at 15-30°C ambient; no cold-chain requirement at any stage, transit or destination. Moisture exclusion is the main packaging consideration for tropical and humid markets.
Pharmacovigilance
A named PV contact organised in the destination market against registration, with Periodic Safety Update Reports compiled to ICH E2C. Because rifaximin's encephalopathy indication concentrates the patient population in advanced liver disease, hepatic-impairment exposure signals and rifamycin cross-sensitivity reactions are the PSUR priority items, even though systemic adverse events are inherently rare given the absorption profile.
The gut-selective and travel-medicine cluster.
Rifaximin's closest pharmacological relative on our roster is oral vancomycin, another antibiotic formulated to stay local rather than absorb; its closest clinical relative is the travellers' diarrhoea cover that ciprofloxacin and azithromycin provide when a fluoroquinolone or a systemic agent is the better fit.
Vancomycin
Glycopeptide; the oral capsule form is likewise non-absorbed and acts locally, for C.difficile colitis.
Ciprofloxacin
Fluoroquinolone, a travellers' diarrhoea option where local resistance patterns favour it over rifaximin.
Azithromycin
Macrolide, preferred travellers' diarrhoea option in fluoroquinolone-resistant regions of South and Southeast Asia.
Metronidazole
Nitroimidazole, anaerobic and protozoal gut infections; a historic, largely superseded encephalopathy adjunct.
All anti-infectives →
180+ anti-infective SKUs: cephalosporins, macrolides, glycopeptides, carbapenems, fluoroquinolones, antifungals.
Gastroenterology →
Lactulose and the wider hepatology and gut-motility lines that sit alongside rifaximin in encephalopathy and IBS management.
Molecule · strength · volume · destination. One working day to a quote, repeat orders routed faster.
- Send us the specifics. Strength (200mg or 400mg tablet), pack size, volume, destination, and channel: hospital hepatology formulary, travel-medicine clinic, or private-pay pharmacy. Flag whether this is a one-off travellers'-diarrhoea-scale order or a recurring maintenance-therapy account, since we route the two differently.
- We route to the right line. 39 branded rifaximin lines on the M Care roster across 200mg and 400mg tablets. We confirm pack format and shelf life at dispatch against your destination's climate and storage conditions.
- Commercial and regulatory offer. FOB / CIF price, CTD dossier status per destination, and the documentation pack you will receive. Inside one working day.
- Order, produce, release, ship. QC release on the Indian side. Ambient-temperature dispatch lane, no cold-chain handling required, in-transit logging, on-arrival inspection.
- After delivery. Batch records and CoA archived for the full shelf life. Maintenance-therapy accounts get reorder timing flagged ahead of stock-out, not a fresh enquiry. Pharmacovigilance contact opened on registration; hepatic-impairment exposure and rifamycin cross-sensitivity remain the PSUR watch items.
Rifaximin supply, the specific questions.
What strengths of rifaximin do you supply, and how do they compare to the branded originator?
The M Care roster carries 200mg and 400mg tablets, 39 branded generic lines in total, supplied under Indian reference brands including Rifakem, Rcifax, Torfix and Sibofix. This is a different strength range from the originator product, sold as Xifaxan (550mg) in the US and Targaxan (550mg) in the UK. Dosing frequency and pattern on a 200mg or 400mg generic line should be confirmed against the destination-market label rather than translated directly from the 550mg originator regimen. Tell us the strength, brand preference and volume and we route to the matching line.
Is rifaximin on the WHO Essential Medicines List?
No. Rifaximin is not a WHO Model List of Essential Medicines molecule, and we do not represent it as one. Its regulatory footing sits with FDA prescribing information and, in the UK, the Targaxan and Xifaxanta product labels. This matters for how the drug moves through procurement: it is not a WHO Prequalification or Global Fund tender commodity the way many of our antibacterial lines are, and buyers should expect a private-formulary or specialist-hospital procurement route rather than a public-health tender one.
Rifaximin barely absorbs. What does that actually change for a buyer?
Oral bioavailability is under 0.4%, so rifaximin acts almost entirely within the gut lumen rather than the bloodstream, which is why it treats hepatic encephalopathy and travellers' diarrhoea but not systemic or invasive infection. The practical upside is a short interaction list compared with an absorbed antibiotic. The one exception is P-glycoprotein: potent P-gp inhibitors, ciclosporin being the clearest documented case, have been shown to raise rifaximin's systemic exposure many-fold, so that specific combination is flagged on the label even though most co-medications are not a concern.
Is rifaximin safe to supply for patients with the liver disease it's meant to treat?
This is worth being precise about. Rifaximin's own absorption stays low regardless of liver function, but in Child-Pugh C (severe) hepatic impairment, the small fraction that does reach the bloodstream is documented to reach substantially higher exposure than in patients with normal liver function. Since hepatic encephalopathy patients are, by definition, a population with liver disease, and some proportion of them will be Child-Pugh C, our destination-language pack inserts carry the exposure note explicitly rather than relying on the general minimal-absorption framing to cover every case. The prescribing decision on dose and monitoring stays with the treating clinician.
Which markets and channels do you supply rifaximin into?
The UK (NHS and private hepatology and gastroenterology services, Targaxan for encephalopathy maintenance and Xifaxanta for travellers' diarrhoea), the GCC (UAE, Saudi Arabia, Kuwait, Oman, Qatar, Bahrain) through licensed local importers into private and semi-private hospital formularies and travel-medicine clinics, and sub-Saharan Africa (Nigeria, Kenya, Ghana, South Africa, Ethiopia, Tanzania, Uganda, Rwanda) through teaching-hospital hepatology units and expatriate-medical-centre channels. Germany under section 72 AMG, France, Brazil (ANVISA), Mexico (COFEPRIS) and the Philippines (FDA Philippines). We do not supply into India. Full market coverage is at markets.
How is a chronic-therapy line like this different from your acute-antibiotic tender business?
Hepatic encephalopathy maintenance therapy is taken indefinitely, alongside lactulose, to reduce recurrence risk, not as a fixed course. That makes rifaximin behave like a repeat-prescription commodity on our side too: buyers on an encephalopathy-maintenance account get reorder flagging ahead of stock-out rather than a fresh enquiry each time, and the commercial relationship is built around supply continuity rather than one-off tender-cycle pricing. Travellers' diarrhoea demand, by contrast, is a short defined course and moves more like our conventional antibiotic lines.
Do you provide CTD dossiers and what documentation ships with a consignment?
Yes. Full CTD Module 3 dossiers are available against a non-disclosure agreement, for registration with the MHRA, GCC central registration, SFDA, MoHAP, NAFDAC, PPB, SAHPRA, EFDA, TMDA, NDA, BfArM, ANSM, ANVISA, COFEPRIS, FDA Philippines and comparable bodies. Every consignment ships with a batch-specific Certificate of Analysis, Method of Analysis, Certificate of Pharmaceutical Product, the manufacturing partner's WHO-GMP certificate, manufacturing licence, Certificate of Origin, and a destination-language pack insert carrying the rifamycin cross-hypersensitivity caution and the hepatic-impairment exposure note. M Care's own ISO 9001:2015 certification covers our export documentation; PV contact nominated on registration.
Send the specifics. You'll have a price inside one working day.
Strength (200mg or 400mg), pack size, volume, destination, and whether this is a one-off travellers'-diarrhoea order or a recurring hepatic-encephalopathy maintenance account, target delivery, and any CTD documentation the formulary needs. That's the enquiry. Everything else is on us.