Olopatadine Eye Drops Manufacturer in India

What We Manufacture

About Olopatadine Eye Drops — 9M India

9M India manufactures Olopatadine Hydrochloride 0.1% w/v eye drops at its WHO-GMP certified sterile ophthalmic facility in Birkoni, Chhattisgarh. Olopatadine is the most widely prescribed anti-allergic eye drop globally — combining dual-acting antihistamine and mast cell stabilising activity for comprehensive allergic conjunctivitis management. Allergic conjunctivitis affects an estimated 20% of the global population and is particularly prevalent in the Middle East, North Africa and South Asia — exactly the markets 9M India exports to — due to high environmental allergen burden from dust, pollen and dry climate conditions. All batches are produced in classified cleanrooms with aseptic fill-finish, 0.2 micron sterile filtration and compendial sterility testing on every batch.

Formulation specifications

Specification	Details
Molecule	Olopatadine Hydrochloride
Concentration	0.1% w/v
Dosage Form	Sterile Ophthalmic Solution
Therapeutic Class	Anti-allergic — Dual-acting Antihistamine + Mast Cell Stabiliser
Pack Options	5ml sterile multi-dose bottle
Preservative	Benzalkonium Chloride 0.01%
pH Range	6.0 – 7.5
Storage	Store below 25°C, protect from light
Shelf Life	24 months
Pharmacopoeial Standard	USP
MOQ	As per enquiry — contact us

Sterile ophthalmic manufacturing at 9M India

All eye drops manufactured by 9M India are produced in classified cleanroom environments with aseptic fill-finish processes. Key manufacturing standards for Olopatadine Eye Drops include:

ISO-classified cleanroom — Grade A/B fill-finish zones
Water for Injection (WFI) manufactured on-site
2 micron sterile filtration for every batch
Sterility testing — compendial method, every batch
Particulate matter analysis — USP <788> / BP compliance
pH, osmolality, assay and preservative content testing
Stability studies — ICH Zone IVb (30°C / 75% RH)

Therapeutic use & clinical indications

Olopatadine works through a unique dual mechanism: H1 histamine receptor antagonism (immediate itch and redness relief) and mast cell stabilisation (preventing further allergic mediator release on allergen re-exposure). This dual action addresses both the immediate allergic response and the underlying cascade — more comprehensive than single-mechanism agents. Its high selectivity for H1 receptors minimises systemic anticholinergic side effects.

Primary Indications:

Seasonal allergic conjunctivitis — triggered by pollen, grasses
Perennial allergic conjunctivitis — triggered by dust mites, pet dander, mould
Vernal keratoconjunctivitis — adjunct management
Contact lens-related allergy — giant papillary conjunctivitis (adjunct)
Paediatric allergic conjunctivitis — approved from 3 years of age

Enquire Now

Who We Supply

Export markets & regulatory readiness

9M India exports Olopatadine eye drops to 15+ countries across Phase 1 markets including the UAE, Iraq, Egypt, Kazakhstan, Sri Lanka and others in the Middle East, CIS, Africa and ASEAN. Allergic conjunctivitis prevalence is highest in these markets, making Olopatadine one of our highest-demand export ophthalmic formulations. Complete WHO-GMP documentation, CoPP and dossier support are available for market registration.

WHO-GMP Certificate
DCGI Manufacturing Licence
Certificate of Pharmaceutical Product (CoPP)
Certificate of Analysis (CoA) — sterility, particulate matter, pH, assay — batch-wise
CTD / ACTD Dossier — on request
Stability Data — ICH Zone IVb (30°C/75% RH)

Partner with 9M India for Olopatadine Eye Drops supply

Whether you are sourcing Olopatadine eye drops for institutional ophthalmic supply, government eye health programmes or export distribution — 9M India delivers WHO-GMP certified sterile manufacturing with complete documentation and reliable supply at scale.

Submit An Enquiry

View All Eye Drop Categories

WHO-GMP
Certified Facility
In-House QC
Contract &
3PM Available
DCGI
Approved

Submit An Enquiry

View All Eye Drop Categories

We keep answer short

Frequently asked questions — Olopatadine Eye Drops

Find answers to the most common questions about our products, services, pricing, and policies.

01

Yes. 9M India manufactures Olopatadine Hydrochloride 0.1% w/v eye drops at its WHO-GMP certified sterile ophthalmic facility in Birkoni, Chhattisgarh. All batches are produced in classified cleanrooms with aseptic fill-finish and sterility testing on every batch. DCGI approved and export-ready for 15+ countries.
02

Olopatadine works through a dual mechanism — it is both an H1 histamine receptor antagonist (providing immediate relief from itching, redness and tearing) and a mast cell stabiliser (preventing degranulation and further histamine release on allergen re-exposure). This dual action provides both immediate symptom relief and longer-term prophylactic benefit — making it more effective than single-mechanism antihistamines or mast cell stabilisers alone.
03

Yes. Olopatadine 0.1% eye drops are approved for use in children from 3 years of age in most regulatory jurisdictions. Allergic conjunctivitis is highly prevalent in the paediatric population across all 9M India's export markets. The formulation is well tolerated in children with no significant safety concerns at the approved dose.
04

Yes. Olopatadine 0.1% is indicated for both seasonal allergic conjunctivitis (pollen, grasses — spring/summer) and perennial allergic conjunctivitis (dust mites, pet dander, mould — year-round). The mast cell stabilising component provides prophylactic benefit with regular use, while the antihistamine provides rapid relief from acute symptoms.
05

Olopatadine 0.1% is available in 5ml sterile multi-dose bottles. Institutional bulk packaging and private label export packaging with custom branding and multilingual labelling are available. Please contact our export team with specific packaging and volume requirements.
06

Documentation available includes WHO-GMP Certificate, DCGI Manufacturing Licence, CoPP, batch-wise CoA (sterility, particulate matter, pH, assay, preservative content), ICH Zone IVb stability data and CTD/ACTD dossiers on request.