Olopatadine eye drops, sold under Pataday, Patanol and Opatanol and now also as FDA and MHRA-licensed generics, for ocular itching and seasonal allergic conjunctivitis.
Olopatadine hydrochloride is a topical antihistamine and mast-cell stabiliser for allergic conjunctivitis, marketed as Pataday and Patanol by Alcon in the US and as Opatanol by Novartis Europharm in the UK and EU. M Care Exports is a merchant exporter: we source originator Pataday/Patanol/Opatanol and FDA or MHRA-licensed generic olopatadine drops through licensed Indian channels and dispatch against buyer specification, not from our own manufacturing.
Also marketed as Pataday Twice Daily Relief, Pataday Once Daily Relief and Patanase.
Olopatadine exporter and bulk supplier from India.
For hospital, wholesaler and tender-desk orders, M Care quotes olopatadine ophthalmic solution against buyer specification: brand (Pataday, Patanol, Opatanol) or generic, concentration (0.1%, 0.2% or 0.7%), dosing frequency implied by strength, pack count and destination-market regulatory documentation. Multiple brand and generic olopatadine lines sit on the M Care roster, so buyers comparing once-daily versus twice-daily formulations, or brand versus generic pricing, can specify either against the same enquiry.
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.
Topical antihistamine (H1-receptor antagonist) with mast-cell-stabilising activity, sourced and documented for export.
Olopatadine hydrochloride is a topical antihistamine (H1-receptor antagonist) with additional mast-cell-stabilising activity, formulated as an ophthalmic solution and, as a combination product, a nasal spray. It is not injected and needs no reconstitution.
The FDA label for Pataday 0.2% covers ocular itching associated with allergic conjunctivitis, dosed once daily. Patanol and generic 0.1% solutions are dosed twice daily, roughly eight hours apart. The UK/EU Opatanol 0.1% SmPC restricts its licensed indication to seasonal allergic conjunctivitis specifically, a narrower wording than the US label; buyers should check the destination-country SmPC or label before quoting an indication to a formulary committee.
Olopatadine drops are supplied as 5ml or 2.5ml fill multidose bottles with a dispensing plug, stored at room temperature (no cold chain) and discarded four weeks after first opening per the UK/EU SmPC, or per the US shelf-life stated on the carton.
Active ingredient
Olopatadine hydrochloride. Topical antihistamine (H1-receptor antagonist) with mast-cell-stabilising activity.
Forms and strengths
0.1 % eye drops; 0.2 % eye drops; 0.7 % eye drops.
Indications
Olopatadine hydrochloride is a topical antihistamine and mast-cell stabiliser indicated for allergic conjunctivitis, sold as Pataday, Patanol and Opatanol ophthalmic solutions at 0.1%, 0.2% and 0.7% concentrations, and as a nasal-spray combination for allergic rhinitis. Supplied from Indian channels to regulated and semi-regulated export markets; not sold into India.
Administration
Ophthalmic, Intranasal. Ophthalmic solution (eye drops); nasal spray (combination product).
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 olopatadine are hospital and community ophthalmology pharmacies, ENT and allergy clinics stocking the nasal-spray combination, national and regional MoH tender desks running ophthalmic and anti-allergy procurement lists, licensed pharmaceutical wholesalers and importers, and retail pharmacy chains sourcing the OTC-switched strengths for over-the-counter allergy season demand.
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 olopatadine.
Confirm which olopatadine strength a tender line is actually asking for before quoting: 0.1% is a twice-daily drop, 0.2% is once-daily, and 0.7% is a higher-strength once-daily OTC formulation; substituting one for another changes the patient's dosing schedule, not just the price. All are preserved multidose eye drops using benzalkonium chloride, which soft contact lenses absorb, so counsel patients to remove lenses before instilling and wait at least ten minutes before reinserting them. Bottles carry no cold-chain requirement and are stored at controlled room temperature, which simplifies freight against biologics on the same order, but the in-use shelf life is short: UK/EU SmPC text requires discarding the bottle four weeks after first opening, so pack-out quantities for a multi-month tender should be split into enough individual bottles to cover that window, not one large fill. Flag hypersensitivity to any excipient as the only absolute contraindication on the label.
The documentation pack a regulator actually asks for.
Olopatadine moves through the standard M Care documentation pack: CTD Module 3 CMC data, per-batch CoA and CoP-A from the manufacturer's QC head, CDSCO-issued CoPP and WHO-GMP or manufacturing licence (apostilled where the destination requires it), destination-language pack inserts and pre-print artwork QC, ambient-transport handling records rather than a cold-chain log, and a named pharmacovigilance contact on file for PSUR reporting to ICH E2C.
Buyers new to sourcing from India usually read the licensed import route explainer first, then the product 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 olopatadine.
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 olopatadine.
- 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.
Olopatadine supply, the specific questions.
Is olopatadine available as a generic, or only as Pataday, Patanol and Opatanol?
Licensed generics exist alongside the originator brands. The FDA has approved multiple ANDA generic olopatadine ophthalmic solutions, including from Glenmark and Dr. Reddy's, and the UK market carries olopatadine eye drops from Brown & Burk and Dawa Limited alongside Novartis's branded Opatanol. Buyers can specify brand or generic against the same enquiry; M Care sources both through licensed Indian channels.
What is the difference between the 0.1%, 0.2% and 0.7% strengths?
They are different dosing schedules, not interchangeable strengths of the same product. The 0.1% solution (Patanol and its generics) is dosed twice daily, roughly eight hours apart. The 0.2% solution (Pataday) is dosed once daily. The 0.7% solution is a higher-strength once-daily OTC formulation sold as Pataday Once Daily Relief Extra Strength and equivalents. A tender specification should state the strength and dosing frequency it wants, not just "olopatadine".
Does olopatadine need cold-chain shipping?
No. Olopatadine ophthalmic solution is stored at controlled room temperature per both the FDA label (2-25°C) and the EU SmPC (no special storage conditions required, product does not require refrigeration), with no cold-chain requirement. This simplifies freight and customs handling compared with biologics or vaccines moving on the same order, though standard pharmaceutical transport documentation still applies.
Is olopatadine eye drop treatment for seasonal allergic conjunctivitis only, or year-round use?
It depends on the destination label. The US Pataday and Patanol labels cover ocular itching associated with allergic conjunctivitis generally, without restricting to seasonal cases. The UK/EU Opatanol SmPC licenses the product specifically for seasonal allergic conjunctivitis and allows continuous use for up to four months if needed. Buyers quoting an indication to a hospital formulary or MoH tender committee should reference the destination-country SmPC or label wording, not a generic description.
How long can an opened bottle of olopatadine eye drops be used?
Per the UK/EU SmPC, the bottle must be discarded four weeks after first opening, regardless of how much solution remains, to reduce contamination risk from repeated dropper contact. Buyers ordering for extended dispensing periods should size pack quantities around the four-week in-use window rather than one large-fill bottle.
Is olopatadine also available as a nasal spray?
Yes, as two separate products. Patanase nasal spray, sold in the US, contains olopatadine hydrochloride alone and is licensed for seasonal allergic rhinitis in patients aged six and over. Ryaltris, sold in the UK and EU, combines olopatadine hydrochloride with mometasone furoate for the same indication. Both are a separate dosage form and licence from the ophthalmic solution; specify which product a tender line actually requires.
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.
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.