Kestine (ebastine), marketed in Spain and Latin America as Ebastel, is a non-sedating second-generation antihistamine licensed for allergic rhinitis and chronic idiopathic urticaria, and licensed generic ebastine tablets from multiple EU and UK manufacturers now sit alongside the originator brand.
M Care Exports supplies Kestine (ebastine), a non-sedating second-generation H1-antihistamine originated by Almirall of Spain and marketed regionally as Ebastel, alongside MHRA- and EU-licensed generic ebastine tablets; the molecule carries no US FDA approval and is not sold in the United States. It is licensed for seasonal and perennial allergic rhinitis and chronic idiopathic urticaria, and does not cross the blood-brain barrier at recommended doses. M Care is a merchant exporter: we source Kestine/Ebastel and generic ebastine through licensed Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.
Ebastine exporter and bulk supplier from India.
For hospital pharmacy, wholesaler and retail-chain orders, M Care quotes ebastine against buyer specification: brand (Kestine/Ebastel) or generic, film-coated tablet, orodispersible lyophilisate or paediatric oral solution, and dose strength (5 mg paediatric, 10 mg standard adult, or the 20 mg regimen for more troublesome symptoms), together with destination-market regulatory documentation, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because ebastine's paediatric dosing steps by age band, 2.5 mg from age two, 5 mg from age six, 10 mg from age twelve, rather than a single adult figure, we confirm the buyer's intended age mix 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.
Second-generation H1-receptor antagonist (non-sedating antihistamine), sourced and documented for export.
Ebastine is a second-generation H1-receptor antagonist that binds peripheral histamine H1 receptors without crossing the blood-brain barrier, giving it a low-sedation profile at recommended doses. The Kestine SmPC's flagship indications are allergic rhinitis, seasonal and perennial, whether or not associated with allergic conjunctivitis, and chronic idiopathic urticaria; the Spanish Ebastel labelling adds allergic dermatitis as a further licensed use. It is dosed orally, not injected, and needs no reconstitution as a tablet, though the paediatric oral solution is measured by dose. Kestine/Ebastel is supplied as a 10 mg film-coated tablet (20 mg once daily, taken as two tablets, for more troublesome or perennial symptoms), a 20 mg orodispersible lyophilisate (Ebastel Forte Flas) for patients who cannot swallow tablets, and a 1 mg/ml paediatric oral solution, all dosed once daily with or without food.
Active ingredient
Ebastine. Second-generation H1-receptor antagonist (non-sedating antihistamine).
Forms and strengths
10 mg film-coated tablet; 20 mg orodispersible lyophilisate; 5 mg/5 ml oral solution.
Indications
Ebastine, a second-generation H1-antihistamine indicated for seasonal and perennial allergic rhinitis and chronic idiopathic urticaria. Supplied as originator Kestine/Ebastel and licensed generic tablets, an orodispersible lyophilisate and a paediatric oral solution from Indian WHO-GMP facilities to regulated and semi-regulated markets outside India.
Administration
Oral. Film-coated 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 ebastine are mainly hospital and community pharmacies dispensing for seasonal and perennial allergic rhinitis and chronic urticaria clinics, national and regional MoH tender desks running allergy and respiratory formulary lists, licensed pharmaceutical wholesalers and importers, and retail pharmacy chains stocking a non-sedating antihistamine alongside cetirizine and loratadine lines.
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 ebastine.
Ebastine's dosing steps by age and hepatic status rather than one adult figure: 10 mg once daily for allergic rhinitis and chronic urticaria, rising to 20 mg (taken as two tablets) for more troublesome or perennial symptoms, but capped at 10 mg in severe hepatic insufficiency; paediatric dosing runs 2.5 mg from age two and 5 mg from age six via the oral solution, before stepping to the adult tablet at twelve. No cold-chain handling or reconstitution is needed for the film-coated tablet, but the oral solution should be shaken and measured by dose. Ebastine is metabolised via CYP3A4 to its active acid metabolite carebastine, so co-prescribing azole antifungals or macrolide antibiotics raises plasma levels and warrants caution in patients with long QT syndrome or hypokalaemia, even though no clinically relevant QT prolongation appears at licensed doses. Because onset takes one to three hours, dispensing counsel should flag that Kestine/Ebastel is unsuitable for urgent acute allergic reactions.
The documentation pack a regulator actually asks for.
As an oral solid or liquid dosage form, ebastine travels on standard ambient-temperature logistics rather than the cold-chain lanes M Care validates for biologics and insulins; the film-coated tablet and orodispersible lyophilisate need no special storage conditions, while the paediatric liquid formats reviewed specify storage below 30°C. What buyers need instead is batch-level certificate of analysis, CDSCO export documentation and, where the destination market requires it, CTD or eCTD-format dossier support so the buyer's own regulator can register the product. Ebastine does not appear on the current WHO Model List of Essential Medicines; chlorphenamine is the antihistamine WHO lists as the essential-medicines reference agent for allergic conditions, so buyers should treat ebastine as a formulary-specific, non-sedating alternative rather than an EML first-line antihistamine when building a tender specification. On the brand-versus-generic question, Kestine (UK, Ireland and other European markets) and Ebastel/Ebastel Forte (Spain and parts of Latin America) remain the Almirall originator products, separately registered generic ebastine tablets from manufacturers marketing in the EU and UK are available alongside them, so buyers genuinely have a brand-or-generic choice. Ebastine has no US FDA approval and is not sold in the United States, so buyers sourcing specifically for that market should look to an FDA-approved antihistamine instead.
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 ebastine.
Adalimumab
Another allergy & immunology line ordered on the same formularies.
Cetirizine
Another allergy & immunology line ordered on the same formularies.
Ciclosporin
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 ebastine.
- 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.
Ebastine supply, the specific questions.
Does a generic version of Kestine or Ebastel exist?
Yes. Licensed generic ebastine tablets from manufacturers registered in the EU and UK are marketed alongside the originator brands Kestine and Ebastel. Registration status for generic ebastine varies by destination country, so M Care checks local approval before quoting brand or generic against a specific tender.
Can M Care supply Kestine or Ebastel to our market?
Yes, on an import basis. We source Kestine/Ebastel through Almirall's 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 ebastine are available?
A 10 mg film-coated tablet, with a 20 mg once-daily regimen (two tablets) available for more troublesome symptoms, a 20 mg orodispersible lyophilisate (Ebastel Forte Flas) for patients who struggle to swallow tablets, and a 1 mg/ml paediatric oral solution. Tell us your patient mix, adult or paediatric, and formulary preference and we quote the format split accordingly.
Is ebastine approved in the United States?
No. Ebastine has no US FDA approval and is not sold in US pharmacies. It is licensed and marketed as Kestine or Ebastel across the UK, EU, Latin America and parts of Asia, and M Care sources it for those regulated and semi-regulated markets, not for US import.
What is the paediatric dosing for ebastine?
Per the manufacturer's oral-solution labelling, children aged two to five take a 2.5 mg dose once daily and children aged six to eleven take 5 mg once daily. From age twelve, patients move to the standard adult tablet dose of 10 mg once daily, rising to 20 mg for more troublesome symptoms.
Does ebastine need any special storage or handling?
No cold-chain handling is required. The film-coated tablet and orodispersible lyophilisate need no special storage conditions beyond standard ambient limits, and the paediatric oral solution is stored below 30°C per the manufacturer's SmPC.
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.
- Approved product information of the supplying manufacturer.
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.