Klacid (clarithromycin), sold in North America as Biaxin, is licensed for respiratory tract, skin and ear infections and as part of H. pylori eradication therapy, and long since off-patent generic clarithromycin tablets and paediatric suspension now dominate most hospital formularies.
Klacid (clarithromycin), originated by Abbott and sold in the US and Canada as Biaxin, is a macrolide antibiotic covering respiratory, skin and ear infections and, combined with a proton pump inhibitor and amoxicillin, Helicobacter pylori eradication. M Care Exports is a merchant exporter: we source the Abbott-originated brand and generic clarithromycin tablets, modified-release tablets and paediatric suspension through licensed Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.
Clarithromycin exporter and bulk supplier from India.
For hospital, wholesaler and MoH tender orders, M Care quotes clarithromycin against buyer specification: brand (Klacid/Biaxin) or generic, immediate-release or modified-release (XL) tablet, adult or paediatric suspension strength, and destination-market regulatory documentation, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because clarithromycin's Watch-group antibiotic status and its long interaction list (statins, colchicine, ergot alkaloids) mean formulary desks scrutinise co-prescribed lines closely, we confirm the buyer's intended regimen and pack format before dispatch, 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; semisynthetic 14-membered ring erythromycin derivative, sourced and documented for export.
Clarithromycin is a semisynthetic 14-membered macrolide, derived from erythromycin, that binds the bacterial 50S ribosomal subunit to block protein synthesis, giving it a broader Gram-positive and atypical-organism spectrum with better acid stability and oral bioavailability than its parent compound. Klacid/Biaxin's licensed indications cover acute bacterial exacerbation of chronic bronchitis, acute maxillary sinusitis, community-acquired pneumonia, pharyngitis and tonsillitis, uncomplicated skin and skin-structure infections, and acute otitis media in children; a separate licensed use covers treatment and prophylaxis of disseminated Mycobacterium avium complex disease, and, combined with a proton pump inhibitor and amoxicillin or metronidazole, Helicobacter pylori eradication in duodenal ulcer disease. Destination-country labelling should be checked against this before a tender quote is finalised. Clarithromycin is supplied as 250mg and 500mg film-coated tablets, a 500mg modified-release (XL) tablet dosed once daily, and 125mg/5mL and 250mg/5mL oral suspension for children.
Active ingredient
Clarithromycin. Macrolide antibiotic; semisynthetic 14-membered ring erythromycin derivative.
Forms and strengths
250 mg film-coated tablet; 500 mg film-coated tablet; 500 mg modified-release (XL) tablet; 125 mg/5 mL oral suspension; 250 mg/5 mL oral suspension.
Indications
Clarithromycin, marketed as Klacid outside North America and Biaxin in the US and Canada, is a macrolide antibiotic indicated for respiratory, skin and ear infections and, in combination regimens, Helicobacter pylori eradication and disseminated Mycobacterium avium complex disease. Supplied as brand or long-established generic from Indian WHO-GMP facilities to regulated and semi-regulated markets.
Administration
Oral. Film-coated tablet (immediate-release and modified-release) and oral suspension for children.
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 clarithromycin are hospital and community-pharmacy respiratory and paediatric services managing bronchitis, sinusitis, pneumonia and otitis media caseloads, gastroenterology units running H. pylori eradication protocols, national and regional MoH tender desks running anti-infective and paediatric formulary lists, licensed pharmaceutical wholesalers and importers, and NGO or public-health procurement programmes stocking a second-line macrolide alongside amoxicillin and azithromycin where a penicillin allergy or atypical-organism cover is needed.
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 clarithromycin.
Clarithromycin's most consequential counselling point at dispensing is its interaction load, not its dosing: it is a potent CYP3A4 inhibitor, so co-administration with lovastatin or simvastatin is contraindicated outright on rhabdomyolysis risk, and combining it with colchicine has produced life-threatening and fatal interactions, particularly in renal or hepatic impairment. Prolonged QT interval and torsades de pointes have been reported with macrolides including clarithromycin, so it should be avoided in patients with known QT prolongation, ventricular arrhythmia or concomitant QT-prolonging drugs. Reconstitution is where the paediatric suspension differs from many antibiotic liquids on the same shelf: once reconstituted it must not be refrigerated or frozen, stored below 25C with the bottle tightly closed, and discarded after 14 days, since chilling thickens the suspension and affects dosing accuracy. Paediatric dosing follows a weight band (roughly 62.5mg to 250mg twice daily depending on weight) over a 5 to 10 day course depending on the pathogen and severity. Use in pregnancy is not advised without weighing benefit against risk, a point worth flagging on any antenatal dispensing record.
The documentation pack a regulator actually asks for.
Clarithromycin tablets, XL tablets and unreconstituted suspension granules ship on standard ambient-temperature, GDP-compliant logistics rather than the validated cold-chain lanes M Care runs for biologics; the reconstituted paediatric suspension is a pharmacy-counter product, not a shipping consideration, and specifically must not be refrigerated once mixed. Clarithromycin sits in WHO's Watch group under the AWaRe antimicrobial classification and has been on the WHO Model List of Essential Medicines since 2011, currently listed for acute pharyngitis (second-choice), bacterial pneumonia and Helicobacter pylori-associated gastric ulcer. On the brand-versus-generic question, Klacid remains Abbott's originator product (marketed as Biaxin in the US and Canada, and also sold regionally as Klaricid), while generic clarithromycin tablets, modified-release (XL) tablets and suspension have been registered for years across the UK, EU, GCC and African markets M Care serves, including the UK-licensed Xetinin XL modified-release brand. Buyers should also note that clarithromycin 125mg/5mL and 250mg/5mL oral suspension were placed under UK serious shortage protocols from 22 May to 21 June 2024, alongside substitution rules between strengths and formats, after a surge in whooping cough cases; we treat that as a live example of why formulary desks keep a secondary export source on file for this molecule.
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 clarithromycin.
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 clarithromycin.
- 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.
Clarithromycin supply, the specific questions.
Is there a generic version of Klacid or Biaxin?
Yes. Generic clarithromycin tablets, modified-release (XL) tablets and paediatric suspension have been registered for years across the UK, EU, GCC and African markets, alongside Abbott's originator Klacid/Biaxin brand. In the UK, generic modified-release tablets such as Xetinin XL are also registered. M Care checks local registration before quoting brand or generic against a specific tender.
Can M Care supply Klacid or Biaxin to our market?
Yes, on an import basis. We source Klacid/Biaxin through licensed Indian distribution channels and dispatch against your import authorisation and any local registration your pharmacy, hospital or wholesaler holds.
What strengths and dosage forms of clarithromycin does M Care supply?
250mg and 500mg film-coated tablets, a 500mg modified-release (XL) tablet, and 125mg/5mL and 250mg/5mL oral suspension for children. Tell us your dosing protocol, patient mix and destination market and we quote the format and strength accordingly.
Does clarithromycin suspension need refrigeration?
No, and it must not be refrigerated. Once reconstituted, the paediatric suspension should be stored below 25C with the bottle tightly closed and used within 14 days; chilling thickens the suspension and can affect dosing accuracy, unlike some other antibiotic suspensions dispensed alongside it.
Is clarithromycin on the WHO Essential Medicines List?
Yes. Clarithromycin has been on the WHO Model List of Essential Medicines since 2011 and sits in the Watch group under the WHO AWaRe antimicrobial classification. It is currently listed for acute pharyngitis, bacterial pneumonia, and Helicobacter pylori-associated gastric ulcer.
What documentation does M Care provide with a clarithromycin shipment?
Batch-level certificate of analysis, CDSCO export documentation from the Indian side, and CTD/eCTD-aligned dossier support where the destination regulator requires local registration before import.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-13.
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.
Form and strength, destination market and indicative volume. The Mumbai desk replies within one working day, including when the honest answer is that the route is not viable yet.