Rulide (roxithromycin) is a macrolide antibiotic whose Australian brand registration was cancelled in 2023 and which no longer appears on the UK's medicines register, yet licensed generic roxithromycin tablets remain registered in France and Germany for respiratory, ENT and urogenital infections.
M Care Exports is a merchant exporter supplying roxithromycin, a macrolide antibiotic marketed internationally by Sanofi as Rulide, alongside licensed generic roxithromycin tablets registered in France and other EU markets. We source through licensed Indian and European distribution channels and dispatch on quote, not from our own manufacturing.
Roxithromycin exporter and bulk supplier from India.
For hospital, wholesaler and tender-desk orders, M Care quotes roxithromycin against buyer specification: strength (150mg, 300mg or the 50mg dispersible paediatric tablet), brand where a brand is still registered in the destination country, or generic, and the regulatory documentation that market requires. Because Rulide's own registration has lapsed or been cancelled in several regulated markets while generic roxithromycin continues to be registered and prescribed in France and Germany, we verify current registration status in the buyer's country before confirming a quote, then align CTD/eCTD or country-specific dossier paperwork to the destination regulator's requirements.
Source
WHO-GMP-certified Indian manufacturing line, named on every quote.
Minimum order
No blanket MOQ. Set by the source manufacturer's minimum batch-release quantity for the strength and pack ordered.
Pricing
On request. Indicative FOB or CIF quote, formal proforma on confirmation.
Incoterms
EXW, FOB, CIF, CIP or DAP.
Payment
Letter of credit (sight or usance) and telegraphic transfer.
Documentation
WHO-GMP certificate of the source line, product-specific CoPP, batch CoA, method of analysis, Free Sale Certificate, Certificate of Origin, CTD or eCTD dossier. On request.
Shelf-life
Minimum remaining shelf-life agreed per order and confirmed on the proforma.
Response
Availability and CoPP status within two working days; pre-alert documents before dispatch.
Macrolide antibiotic, 14-membered ring, oxime derivative of erythromycin, sourced and documented for export.
Roxithromycin is a semi-synthetic 14-membered macrolide, an oxime-ring derivative of erythromycin that inhibits bacterial protein synthesis by binding the 50S ribosomal subunit. Its lower affinity for cytochrome P450 gives it a materially cleaner drug-interaction profile than erythromycin, one reason it has stayed on prescribing lists for polypharmacy and elderly patients even as azithromycin and clarithromycin have taken more of the macrolide market. It is licensed for community-acquired pneumonia, alongside ENT, skin and soft-tissue and non-gonococcal urogenital infections, and its dosing guidance also covers atypical pneumonia presentations. It is oral-only, needs no reconstitution, and absorbs best taken at least 15 minutes before food since a meal reduces uptake. Roxithromycin is supplied as 150mg and 300mg film-coated tablets, dosed once or twice daily, and a 50mg dispersible tablet (Rulide D) for children unable to swallow a solid dose form.
Active ingredient
Roxithromycin. Macrolide antibiotic, 14-membered ring, oxime derivative of erythromycin.
Forms and strengths
150 mg film-coated tablet; 300 mg film-coated tablet; 50 mg dispersible tablet.
Indications
Roxithromycin, a semi-synthetic 14-membered macrolide antibiotic and oxime derivative of erythromycin, indicated for respiratory tract, ENT, skin and soft-tissue and non-gonococcal urogenital infections. Never FDA approved and no longer UK-listed, but licensed generic and Sanofi-brand roxithromycin remain registered in France, Germany and other EU markets, sourced by M Care through Indian and European distribution channels to regulated and semi-regulated export markets outside India.
Administration
Oral. Film-coated tablet and dispersible tablet.
Documentation
Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.
Hospital pharmacies, licensed importers and tender desks across our export markets.
India is our origin. We do not sell into the Indian market.
Buyers for roxithromycin are hospital respiratory and infectious-disease pharmacies in markets where the molecule remains on formulary, paediatric wards using the dispersible tablet for children who cannot swallow a solid dose form, national and regional MoH tender desks running anti-infective procurement lists, and licensed pharmaceutical wholesalers and importers who confirm current local registration before listing the product.
GCC registration routes
Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.
UK unlicensed routes
Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.
Tender desks
Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.
Dossier support
CTD documentation from the sourcing manufacturer, compiled for your regulator's format.
What the dispensing pharmacist checks on roxithromycin.
Roxithromycin's dosing is straightforward, 150mg twice daily or 300mg once daily, but timing matters more than with most oral antibiotics: it should be taken at least 15 minutes before a meal, since food measurably reduces absorption, so counselling at dispensing should flag this rather than leaving it to the patient information leaflet. Streptococcal throat infection needs a minimum ten-day course to reduce the risk of rheumatic complications, longer than the five-to-seven day courses used for most respiratory and soft-tissue indications, so pack-size planning should match the intended diagnosis. Roxithromycin's chief clinical advantage is pharmacokinetic: its low affinity for cytochrome P450 gives it materially fewer drug interactions than erythromycin, which matters for elderly or polypharmacy patients on ciclosporin, warfarin or ergot derivatives. No cold-chain handling or reconstitution is required; tablets store at controlled room temperature. QT-prolongation caution applies as a macrolide-class effect, so concurrent QT-prolonging medicines should be reviewed at dispensing.
The documentation pack a regulator actually asks for.
As an oral tablet, roxithromycin ships on standard ambient logistics, not the validated cold-chain lanes M Care runs for biologics. What buyers need instead is batch-level certificate of analysis, CDSCO export documentation and, where the destination regulator requires local registration, CTD or eCTD-format dossier support. Roxithromycin is not on the WHO Model List of Essential Medicines and carries no WHO AWaRe classification; azithromycin, clarithromycin and erythromycin are the macrolides WHO does list, so tender desks should treat roxithromycin as a formulary-specific choice rather than an EML first-line macrolide. It has never held US FDA approval, and its regulatory footprint has been shrinking elsewhere: Australia's TGA cancelled the Rulide 150mg tablet registration in 2023, and no roxithromycin product currently appears on the UK's electronic medicines compendium, so buyers needing UK-aligned regulatory documentation should look to azithromycin or clarithromycin instead. Generic roxithromycin remains registered in France, where Zentiva France holds a licensed generic line alongside Sanofi's own Rulid brand, and Sanofi's Rulid brand remains separately authorised in Germany and several other EU member states; buyers in these markets have a genuine, if brand-light, supply choice, though M Care confirms current registration status before quoting given how dated national registers can become. Roxithromycin is not a controlled substance in the markets we currently review.
If your question is the route rather than the molecule, start with the licensed route for importing medicines from India and come back here for the product specifics.
CoA and MoA, per batch
Batch-specific certificate and method of analysis from the sourcing manufacturer's QC release.
CoPP, WHO-GMP, MFG licence
Certificate of pharmaceutical product and site GMP certification issued via CDSCO channels, naming the actual manufacturing site.
CTD Module 3
Chemistry, manufacturing and controls documentation available from the sourcing manufacturer for registration filings.
Pack insert, labels, artwork
Destination-language patient information and labelling to the local regulator's standard, locked before shipment.
Pharmacovigilance
A named PV contact arranged in the destination market where the registration requires one.
Adjacent lines procurement desks order alongside roxithromycin.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Form and strength, pack preference, destination market and indicative volume for roxithromycin.
- We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
- Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
- Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
- After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Roxithromycin supply, the specific questions.
Is roxithromycin approved by the US FDA?
No. Roxithromycin has never held US FDA approval and is not marketed in the United States. It is available in France, Germany and a number of other regulated and semi-regulated markets, which is where M Care's supply lines are anchored.
Is roxithromycin on the WHO Essential Medicines List?
No. Roxithromycin does not appear on the WHO Model List of Essential Medicines and so carries no WHO AWaRe classification. Azithromycin, clarithromycin and erythromycin are the macrolides WHO does list; tender desks should treat roxithromycin as a formulary-specific alternative rather than an EML first-line macrolide.
Does the original Rulide brand still exist?
Its footprint is shrinking. Australia's TGA cancelled the Rulide 150mg tablet registration in 2023, and no roxithromycin product currently appears on the UK's electronic medicines compendium. Generic roxithromycin remains registered in France, and Sanofi's Rulid brand remains authorised in Germany and other EU states, so M Care confirms current registration status in the buyer's country before quoting.
What strengths and forms of roxithromycin can M Care supply?
150mg and 300mg film-coated tablets, and a 50mg dispersible tablet for children who cannot swallow a solid dose form, matching the Rulide and Rulide D presentations. Tell us your indication mix and dosing protocol and we quote the strength split accordingly.
How should roxithromycin be taken relative to food?
At least 15 minutes before a meal. Food measurably reduces roxithromycin's absorption, so dispensing counselling should flag the timing rather than leaving it to the patient information leaflet.
Why might a prescriber choose roxithromycin over another macrolide?
Its lower affinity for cytochrome P450 gives it materially fewer drug interactions than erythromycin, which matters for elderly or polypharmacy patients on medicines such as ciclosporin, warfarin or ergot derivatives. Its dosing also supports both twice-daily and once-daily regimens, including the atypical-pneumonia dosing schedule.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-19.
This page is sourcing information for licensed importers, hospital procurement and tender desks. It is not medical, pharmaceutical or prescribing advice, and it is not a substitute for the approved product information of the line on your order. See our full disclaimer.
Send the specifics. You'll have a price inside one working day.
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