Zyrtec (cetirizine), sold in the UK as Zirtek, is licensed for allergic rhinitis and chronic urticaria, and because the molecule has been off-patent since 2007 it now ships mainly as a genericised, high-volume OTC line rather than a single-brand tender item.
M Care Exports is a merchant exporter of cetirizine hydrochloride, the second-generation H1-antihistamine originated as Zyrtec and sold in the UK as Zirtek, now supplied worldwide overwhelmingly as generic tablets, chewables and oral solution rather than a protected brand. We source both the originator line and FDA- and MHRA-licensed generic cetirizine through Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.
Cetirizine exporter and bulk supplier from India.
Cetirizine moves as a high-volume, low-unit-cost oral generic, so tender quotes are built around pack format, strength split (5 mg, 10 mg tablet; 1 mg/mL solution) and destination-market OTC-versus-pharmacy-only classification rather than a brand-versus-generic negotiation. M Care quotes retail-pack and hospital bulk-pack cetirizine against buyer specification, drawn from multiple WHO-GMP partner lines on the roster, with batch-specific certificates of analysis and CDSCO export documentation attached to every shipment.
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, peripherally selective H1-receptor antagonist; piperazine derivative and active metabolite of hydroxyzine, sourced and documented for export.
Cetirizine hydrochloride is a second-generation, selective peripheral H1-receptor antagonist and the major active carboxylic-acid metabolite of hydroxyzine. Its selectivity for peripheral over central H1 receptors is what gives it a materially lower sedation rate than first-generation antihistamines such as chlorphenamine, though sedation is still its most common dose-related side effect. The FDA label covers relief of symptoms associated with allergic rhinitis, both seasonal and perennial, and chronic urticaria; the UK/EU label for Zirtek is more specific, naming relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis and relief of symptoms of chronic idiopathic urticaria. Cetirizine is an oral therapy only, supplied as 5 mg and 10 mg film-coated tablets and as a 1 mg/mL oral solution (also marketed as a chewable tablet in some markets), taken once or twice daily depending on age and destination-market posology.
Active ingredient
cetirizine hydrochloride (cetirizine dihydrochloride in UK/EU labelling). Second-generation, peripherally selective H1-receptor antagonist; piperazine derivative and active metabolite of hydroxyzine.
Forms and strengths
5 mg film-coated tablet; 10 mg film-coated tablet; 1 mg/mL oral solution.
Indications
Second-generation H1-antihistamine indicated for relief of allergic rhinitis, seasonal and perennial, and chronic urticaria, with materially lower sedation than first-generation antihistamines. M Care sources the originator brand via licensed distribution channels and licensed generic cetirizine from Indian WHO-GMP manufacturing partners, dispatching both to regulated and semi-regulated markets outside India.
Administration
oral. Film-coated tablet and oral solution.
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 cetirizine are retail and hospital pharmacy chains restocking a high-turnover OTC allergy line, national and regional MoH tender desks including cetirizine on primary-care and essential-medicine procurement lists, licensed pharmaceutical wholesalers and importers running a general-medicine or seasonal-allergy range, and NGO or humanitarian procurement programmes stocking basic antihistamine cover alongside oral rehydration and analgesic supplies. Because the molecule is genericised worldwide, volume and reliability of supply matter to this buyer more than brand loyalty.
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 cetirizine.
Renal impairment needs a dose reduction scaled to glomerular filtration rate: down to 5 mg every two days at eGFR 15 to under 30 mL/min, and cetirizine is contraindicated outright below that (eGFR under 15 mL/min, dialysis-dependent) per the UK SmPC; children with renal impairment need an individualised dose based on renal clearance, age and body weight rather than the fixed adult bands. Somnolence is the most common dose-related adverse effect: the FDA label records it in 6% of placebo patients versus 11% at 5 mg and 14% at 10 mg, so patients should be counselled before driving or operating machinery, particularly at initiation. A notable withdrawal effect worth flagging at dispensing: pruritus and urticaria can recur when cetirizine is stopped after regular use, sometimes prompting an unnecessary re-diagnosis rather than a straightforward re-start. As a piperazine derivative and hydroxyzine metabolite, cross-reactivity is possible in patients with a documented hydroxyzine or piperazine-antihistamine hypersensitivity.
The documentation pack a regulator actually asks for.
As an oral tablet and solution, cetirizine needs no cold chain. UK SmPC labelling states the tablets and oral solution require no special storage conditions, with the oral solution carrying a 5-year shelf life unopened and 3 months once opened; the FDA label for the US tablet and syrup instead specifies controlled room temperature (20-25C, excursions permitted to 15-30C). 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. Cetirizine is not a controlled substance in any market M Care serves and is sold over the counter in the great majority of destination markets, which is the main reason it ships as high-volume generic stock rather than a single-brand tender line. On the brand-versus-generic question, cetirizine's US patent expired in 2007 and its UK/EU exclusivity lapsed earlier still; the originator Zyrtec (US) and Zirtek (UK) brands now compete against a very wide field of licensed generic cetirizine hydrochloride manufacturers, so buyers effectively always have a generic option and M Care quotes accordingly. Cetirizine was newly added to the WHO Model List of Essential Medicines in the 24th edition (2025, TRS 1064), listed under allergic or hypersensitivity conditions of unspecified type as a therapeutic equivalent to loratadine, formalising a status the molecule had held informally on national formularies for years.
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 cetirizine.
Adalimumab
Another allergy & immunology line ordered on the same formularies.
Ciclosporin
Another allergy & immunology line ordered on the same formularies.
Dupilumab
Another allergy & immunology line ordered on the same formularies.
All allergy & immunology
The full category listing for procurement desks.
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 cetirizine.
- 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.
Cetirizine supply, the specific questions.
Does a generic version of Zyrtec or Zirtek exist?
Yes, and it dominates the market. Cetirizine's patent protection lapsed in the US in 2007 and earlier in the UK and EU, so licensed generic cetirizine hydrochloride is now manufactured and marketed widely alongside the originator Zyrtec and Zirtek brands. M Care sources generic cetirizine from WHO-GMP partner lines as the default, quoting the originator brand only where a tender specifically names it.
What is cetirizine licensed to treat?
Its core licensed uses are allergic rhinitis, both seasonal and perennial, and chronic urticaria. UK and EU labelling names relief of nasal and ocular allergic-rhinitis symptoms specifically, alongside chronic idiopathic urticaria. Check destination-country labelling for the exact approved wording your market requires.
What strengths of cetirizine does M Care supply?
5 mg and 10 mg film-coated tablets and 1 mg/mL oral solution, matching the Zyrtec and Zirtek strengths and the equivalent generic lines. Tell us your pack format, retail or hospital bulk, and age-group split and we quote accordingly.
Does cetirizine need cold-chain shipping?
No. Cetirizine tablets and oral solution require no special storage conditions per UK SmPC labelling and move on standard ambient logistics, not the validated cold-chain lanes M Care runs for biologics and vaccines.
Is cetirizine a controlled substance?
No. Cetirizine is not scheduled as a controlled drug in any market M Care currently reviews, and it is sold over the counter in most destination markets, which keeps documentation closer to a standard OTC generic line than to a prescription-only or controlled-drug shipment.
Is cetirizine on the WHO Essential Medicines List?
Yes, since the 24th edition in 2025 (WHO Technical Report Series 1064), where it is listed under allergic or hypersensitivity conditions of unspecified type as a therapeutic equivalent to loratadine. It is a recent addition, reflecting how established the molecule already was on national formularies before the listing.
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.