Claritin (loratadine) has been an over-the-counter, multi-sourced generic since 2002, so the buyer's question is rarely brand availability and almost always which of the tablet, RediTabs, chewable or syrup formats a tender specifies.
Claritin (loratadine), the Bayer-marketed originator sold in the UK as Clarityn, is a second-generation antihistamine that has carried FDA-approved generic competition since shortly after its 2002 prescription-to-OTC switch. M Care Exports is a merchant exporter: we source both the originator brand and licensed generic loratadine through Indian distribution and WHO-GMP manufacturing channels, and dispatch against a buyer's own specification and import documentation.
Loratadine exporter and bulk supplier from India.
Loratadine is one of the widest-format lines on our anti-allergy roster: standard tablets, orally disintegrating RediTabs, 5 mg chewables for younger children, and 1 mg/mL syrup, spread across multiple stocked strengths and pack sizes. Because it is an ambient-stable oral solid or ready-to-use syrup with no reconstitution step, tender desks can bulk-order across formats in a single container without cold-chain planning. We quote brand or generic against the buyer's own tender wording, since both are genuinely interchangeable bioequivalent options in most of our markets.
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-receptor antagonist (antihistamine), piperidine derivative, sourced and documented for export.
Loratadine is a second-generation, non-sedating H1-receptor antagonist. Unlike first-generation antihistamines, it does not cross the blood-brain barrier appreciably at labelled doses, which is why it is marketed as a non-drowsy option.
The FDA OTC label covers temporary relief of hay fever and upper respiratory allergy symptoms: runny nose, sneezing, itchy watery eyes, and itching of the nose or throat. The UK Clarityn SmPC, held by Bayer under MHRA authorisation, extends this to the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria, and WHO lists loratadine on its Model List of Essential Medicines under antiallergics and medicines used in anaphylaxis.
Loratadine ships as a 10 mg standard tablet, a 10 mg orally disintegrating RediTabs format for patients who struggle to swallow tablets, a 5 mg chewable tablet aimed at younger children, and a 1 mg/mL oral syrup for the under-6 age band and adults who prefer a liquid dose. No reconstitution is needed for any format; the syrup is dispensed ready-to-use.
Active ingredient
loratadine. Second-generation, non-sedating H1-receptor antagonist (antihistamine), piperidine derivative.
Forms and strengths
1 mg/mL oral syrup; 5 mg chewable tablet; 10 mg tablet; 10 mg orally disintegrating tablet.
Indications
Non-sedating antihistamine indicated for the temporary relief of allergic rhinitis symptoms per the FDA OTC label, and for allergic rhinitis and chronic idiopathic urticaria per the UK Clarityn SmPC. Listed on the WHO Essential Medicines List as 10 mg and chewable tablets and a 1 mg/mL liquid.
Administration
oral. Tablet, orally disintegrating tablet (RediTabs), chewable tablet and oral syrup.
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.
Hospital and community pharmacists building an allergy-season formulary, MoH tender desks running annual OTC and essential-medicines procurement rounds, licensed importers and wholesalers stocking antihistamine ranges across our GCC and African markets, and NGO or camp-health procurement teams sourcing a WHO-EML-listed antihistamine for basic-needs kits are the typical buyers. Many enquiries specify format mix, not just strength: a tender covering a paediatric population usually wants syrup and chewables alongside adult tablets in the same purchase order.
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 loratadine.
Standard adult and paediatric (6 years and over) dosing is 10 mg once daily, taken with or without food; there is no titration. Children aged 2 to 5 years are dosed lower, at 5 mg once daily, using the chewable tablet or the 1 mg/mL syrup rather than splitting a 10 mg tablet, since the label does not support that. Confirm which age band a requisition covers before packing a mixed-format order.
Hepatic impairment changes the interval, not the dose: patients with severe liver disease are started on 10 mg every other day, because reduced hepatic clearance extends loratadine's half-life. This is worth flagging on any dispensing note attached to a hospital-pharmacy order, since it is a scheduling change rather than a strength change.
None of the four formats need reconstitution, cold-chain handling or special administration technique. Tablets and RediTabs store at controlled room temperature (20-25C) with no refrigeration requirement, the syrup is dispensed ready-to-use straight from the bottle, and the chewable needs no water. That keeps freight, bonded warehousing and last-mile distribution simple for tender lots moving into markets without validated pharma cold storage.
Breastfeeding mothers are generally advised to avoid loratadine, as it is excreted in breast milk; pregnancy data from over a thousand exposures show no signal of malformation or fetal toxicity, though avoidance remains the precautionary default on the UK label.
The documentation pack a regulator actually asks for.
As an ambient-stable oral solid or ready-to-use syrup, loratadine carries none of the cold-chain documentation burden of injectable lines: no time-out-of-refrigeration logs, no validated cold-chain lane requirement. What M Care compiles instead is the standard small-molecule export file, batch-specific certificate of analysis, CDSCO export documentation from the Indian side, and CTD or country-specific dossier support where a destination regulator requires local registration, since OTC status in the country of manufacture does not exempt a shipment from the importing market's own MoH or pharmacy-board registration process.
On brand versus generic: Claritin (Clarityn in the UK) is the Bayer-marketed originator, and FDA-approved generic loratadine, including ANDA-approved lines such as Apotex's, has been on the market since shortly after the 2002 OTC switch. Loratadine's WHO-EML listing (first added 2013, covering the 10 mg tablet, the 5 mg and 10 mg chewable tablets, and the 1 mg/mL liquid form) further supports its inclusion on national essential-medicines and public-procurement lists. M Care presents brand and generic honestly as an interchangeable choice and quotes either against the tender's own wording; we hold no manufacturing licence or WHO-GMP certification of our own and source every batch from a WHO-GMP-capable partner.
How a licensed importer actually brings a consignment like this in is covered once, in the licensed import route guide, rather than repeated on every molecule page.
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 loratadine.
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 loratadine.
- 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.
Loratadine supply, the specific questions.
Is there a generic version of Claritin (loratadine)?
Yes. FDA-approved generic loratadine, including ANDA-approved products such as Apotex's, has been available since shortly after Claritin's 2002 switch from prescription to over-the-counter status. Brand and generic loratadine are bioequivalent, so M Care quotes either against the wording of your tender or purchase order.
Can M Care supply Claritin (Clarityn) to our market?
Yes, on an import basis. We source the Bayer-marketed originator, sold as Claritin in the US and Clarityn in the UK, through licensed Indian distribution channels and dispatch against your own import authorisation and destination MoH registration requirements.
What formats and strengths of loratadine does M Care stock?
Standard 10 mg tablets, 10 mg orally disintegrating RediTabs, 5 mg chewable tablets for younger children, and 1 mg/mL oral syrup, across multiple pack sizes. Tell us your age-band mix and we quote the format split accordingly.
Does loratadine need cold-chain shipping?
No. All four formats, tablets, RediTabs, chewables and syrup, are ambient-stable and stored at controlled room temperature (20-25C). None require reconstitution, so freight and warehousing follow standard GDP-compliant logistics rather than a validated cold-chain lane.
What documentation does M Care provide with a loratadine shipment?
A batch-specific certificate of analysis, CDSCO export documentation from India, and CTD or country-specific dossier support where the destination regulator requires local registration before import, since OTC status in one market does not exempt a shipment from another market's own registration process.
Is loratadine a controlled or prescription-only medicine?
No. Loratadine is over-the-counter in the US and a General Sale List (GSL) or pharmacy medicine in the UK, and it is not a controlled substance. It is listed on the WHO Essential Medicines List, which supports its inclusion on national and public-procurement formularies even where local registration is still required for 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 2026-09-11.
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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