M Care's levocetirizine catalogue includes a 10mg tablet that exceeds the 5mg daily maximum on FDA and EMA labels, so destination registration, not renal dosing alone, decides which SKU an importer can actually order.
Levocetirizine leaves the body almost entirely unchanged through the kidneys, so its dosing is not a single fixed number: FDA and EMA labels step the interval down by creatinine clearance band, from once daily to twice weekly, and stop altogether in end-stage renal disease. M Care Exports supplies levocetirizine dihydrochloride oral tablets and oral suspension sourced from WHO-GMP certified Indian manufacturers, for regulatory affairs teams, hospital procurement and tender desks across the UK, EU, Gulf, Africa, Latin America, Southeast Asia and CIS.
Levocetirizine exporter and bulk supplier from India.
Levocetirizine ships as oral tablets in blister strips and as oral suspension in 30ml and 60ml bottles, both packed for ambient-temperature air and sea freight; the molecule requires no cold chain. Export documentation includes the Certificate of Pharmaceutical Analysis, Certificate of Origin, and a free sale certificate from the sourcing manufacturer, alongside M Care's own CDSCO export licence and ISO 9001:2015 certificate. Because the catalogue's 10mg tablet exceeds the 5mg-per-day maximum labeled in FDA- and EMA-regulated markets, buyers in those destinations should confirm local marketing-authorisation status for that specific strength before ordering; the 5mg tablet and 2.5mg/5ml suspension align with standard international labeling and carry no such flag.
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.
Second-generation (non-sedating) H1-antihistamine, R-enantiomer of cetirizine, sourced and documented for export.
Levocetirizine dihydrochloride is unusual among antihistamines in how directly kidney function governs its dosing: roughly 85 percent of an oral dose is excreted unchanged in urine, so systemic exposure rises in near-linear steps as creatinine clearance falls. Both the FDA and EMA respond with a stepped schedule rather than a flat daily dose: 2.5mg once daily for mild impairment, once every other day for moderate impairment, twice weekly for severe impairment, and the drug is contraindicated outright in end-stage renal disease and in patients on hemodialysis. Levocetirizine itself is the single R-enantiomer of cetirizine, a second-generation H1-antihistamine indicated for allergic rhinitis and chronic idiopathic urticaria, with less sedation than first-generation agents though somnolence is still a listed effect. M Care's catalogue is entirely single-entity, with no fixed-dose combination lines.
Active ingredient
Levocetirizine dihydrochloride. Second-generation (non-sedating) H1-antihistamine, R-enantiomer of cetirizine.
Forms and strengths
5 mg; 10 mg; 2.5 mg/5ml.
Indications
Levocetirizine dihydrochloride is a second-generation H1-antihistamine, the single active R-enantiomer of cetirizine, indicated for the relief of allergic rhinitis and chronic idiopathic urticaria; supplied as oral tablets and oral suspension.
Administration
Oral. Tablet, Oral suspension.
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.
Levocetirizine's buyer base splits by therapeutic use as much as by geography. Hospital and retail pharmacy procurement across the UK and EU order it as a standard second-generation antihistamine line for allergic rhinitis and chronic urticaria formularies, often alongside cetirizine and desloratadine. Gulf and GCC importers stock it for high pollen-load and dust-exposure seasons, frequently through tender desks supplying government and private hospital networks. African distributors and Latin American licensed importers order both the tablet and the oral suspension, the suspension being relevant for pediatric use and for adults who cannot manage a full tablet dose. Southeast Asian and CIS buyers request both strengths for retail antihistamine ranges and hospital outpatient dispensing.
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 levocetirizine.
A reviewing pharmacist checks renal function status first: levocetirizine is cleared predominantly by glomerular filtration and active tubular secretion, with roughly 85 percent recovered unchanged in urine, so AUC rises in near-linear steps as creatinine clearance falls, from about 1.8-fold in mild impairment up to 5.7-fold in end-stage renal disease. That makes the label's dosing-interval reduction, not a dose reduction alone, the operative safety mechanism, and hemodialysis patients are excluded from the label entirely rather than dose-adjusted. Second, the pharmacist confirms which strength is being registered where: 5mg is the labeled ceiling in FDA- and EMA-regulated markets, so a 10mg tablet needs its own local marketing-authorisation check rather than an assumption that it mirrors the 5mg dossier. Third, CNS depressant and alcohol co-administration is flagged, since somnolence and psychomotor impairment remain listed adverse effects despite levocetirizine's lower sedation profile relative to first-generation antihistamines. Hepatic impairment alone, without renal involvement, does not require dose adjustment per the label.
The documentation pack a regulator actually asks for.
M Care sources levocetirizine dihydrochloride tablets and oral suspension exclusively from WHO-GMP certified Indian manufacturers. M Care itself is a merchant-exporter holding ISO 9001:2015 certification and a CDSCO export licence, and does not hold and has never claimed WHO-GMP or WHO-PQ status directly. Each shipment carries a Certificate of Pharmaceutical Analysis confirming assay, related substances and dissolution against pharmacopoeial limits, a Certificate of Origin, and the manufacturer's free sale certificate. Because the catalogue spans a 10mg strength alongside the standard 5mg tablet and 2.5mg/5ml suspension, the documentation pack for the 10mg line should be checked against the importing country's registered maximum dose rather than assumed equivalent to the 5mg dossier; regulatory affairs teams in FDA- and EMA-aligned markets should verify local authorisation before including that strength in a tender submission. No fixed-dose combination lines are carried, keeping the dossier a single-entity antihistamine review.
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.
What a buyer should know before this line enters a formulary.
We publish the awkward facts alongside the useful ones. A supplier who omits them is not saving you work, only deferring it.
Contraindicated in end-stage renal disease (CrCl below 10 mL/min) and in patients undergoing hemodialysis
Dose-interval reduction required for mild, moderate and severe renal impairment per FDA and EMA labeling; not a simple dose reduction
10mg tablet strength exceeds the 5mg-per-day maximum labeled in FDA- and EMA-regulated markets; importers must verify local marketing-authorisation status before ordering
Somnolence, fatigue and psychomotor impairment are listed adverse effects; caution advised for driving, operating machinery, and co-administration with alcohol or CNS depressants
M Care Exports is a merchant-exporter, not a manufacturer; holds ISO 9001:2015 certification and a CDSCO export licence only, and makes no WHO-GMP or WHO-PQ claim
India is the country of origin only and is not a served market
Adjacent lines procurement desks order alongside levocetirizine.
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 levocetirizine.
- 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.
Levocetirizine supply, the specific questions.
Does M Care hold WHO-GMP or WHO-PQ certification directly?
No. M Care Exports is a merchant-exporter, not a manufacturer. It holds ISO 9001:2015 certification and a CDSCO export licence, and sources levocetirizine from WHO-GMP certified Indian manufacturers. Manufacturer-level WHO-GMP or WHO-PQ documentation is issued by the manufacturer, not claimed by M Care.
Why does the levocetirizine dosing schedule change with kidney function rather than just the dose?
About 85 percent of a levocetirizine dose is excreted unchanged by the kidneys, so exposure rises sharply as renal function declines. FDA and EMA labels respond by widening the dosing interval, from daily to every other day to twice weekly, as creatinine clearance falls, and the drug is contraindicated in end-stage renal disease and in patients on hemodialysis.
Is the 10mg levocetirizine tablet registered in our market?
M Care cannot confirm registration status market by market. The 5mg tablet and 2.5mg/5ml oral suspension align with the standard maximum daily dose labeled by FDA and EMA; the 10mg tablet exceeds that ceiling, so importers should verify local marketing-authorisation status for the 10mg strength with their own regulatory affairs team before ordering.
What forms of levocetirizine does M Care supply?
M Care supplies oral tablets, in 5mg and 10mg strengths, and oral suspension at 2.5mg/5ml in 30ml and 60ml bottles, sourced from WHO-GMP certified Indian manufacturers. M Care does not supply levocetirizine capsules, injections, topical, ophthalmic, inhaled or sachet formulations.
What documentation accompanies a levocetirizine shipment?
Each shipment carries a Certificate of Pharmaceutical Analysis, a Certificate of Origin, and the sourcing manufacturer's free sale certificate, alongside M Care's own ISO 9001:2015 certificate and CDSCO export licence, all supplied to support the importer's own customs clearance and local registration filing.
Can levocetirizine be used in patients on hemodialysis?
No. Levocetirizine is contraindicated in end-stage renal disease, including patients undergoing hemodialysis, per FDA and EMA labeling. Confirming eligibility for a specific patient population is a decision for the buyer's own clinical and regulatory teams, not one M Care Exports makes.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-08-22.
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.
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