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Anti-Allergic Eye Drops Manufacturer in India
WHO-GMP certified sterile anti-allergic ophthalmic manufacturing — Olopatadine, Ketotifen and Sodium Cromoglycate eye drops — for domestic institutional supply and international export across 15+ countries.
Key Highlights
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WHO-GMP
Certified Sterile Ophthalmic Facility -
Sterile Cleanroom
· Grade A/B Manufacturing -
DCGI Approved
Formulations -
Export-Ready
What We Manufacture
Anti-allergic eye drop manufacturing at 9M India
9M India manufactures anti-allergic eye drops at its WHO-GMP certified sterile ophthalmic facility in Birkoni, Chhattisgarh. Allergic conjunctivitis is among the most prevalent ophthalmic conditions globally, affecting an estimated 20% of the population across all age groups. Demand is particularly high in Middle Eastern, South Asian and African markets where environmental allergen burden is significant. Our anti-allergic ophthalmic portfolio includes antihistamine eye drops (Olopatadine, Ketotifen) and mast cell stabilisers (Sodium Cromoglycate) — manufactured under classified cleanroom conditions with aseptic fill-finish, sterility testing and full stability data for export registration.
Formulations — Anti-allergic Eye Drops
Our anti-allergic eye drops eye drop range covers the following molecules and formulations:
| Molecule / Formulation | Details |
| Olopatadine Eye Drops | 0.1% w/v — Dual-acting antihistamine + mast cell stabiliser. First-line anti-allergic ophthalmic. |
| Ketotifen Eye Drops | 0.025% w/v — Antihistamine + mast cell stabiliser. Suitable for seasonal and perennial allergic conjunctivitis. |
| Sodium Cromoglycate Eye Drops | 2% w/v — Mast cell stabiliser. Prophylactic use for allergic conjunctivitis, vernal keratoconjunctivitis. |
| Levocabastine Eye Drops | 0.05% w/v — Selective H1 antihistamine. Rapid symptomatic relief for allergic conjunctivitis. |
| Azelastine Eye Drops | 0.05% w/v — Antihistamine eye drops for seasonal allergic conjunctivitis. |
Sterile ophthalmic manufacturing at 9M India
All eye drops manufactured by 9M India — including anti-allergic eye drops formulations — are produced in classified cleanroom environments with aseptic fill-finish processes. Key manufacturing standards 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)
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WHY 9M INDIA
Why pharmaceutical buyers choose 9M India for anti-allergic eye drops eye drops
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Dual-acting formulations — antihistamine + mast cell stabiliser
Modern anti-allergic eye drops like Olopatadine and Ketotifen combine both antihistamine activity (for immediate symptom relief) and mast cell stabilisation (for prevention of future allergic response) in a single formulation. 9M India manufactures these advanced dual-acting anti-allergic eye drops under WHO-GMP sterile conditions — a more complete therapeutic solution than single-mechanism alternatives.
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High demand in allergen-heavy export markets
Allergic conjunctivitis prevalence is highest in exactly the markets 9M India exports to — the Middle East (high dust and pollen burden), South Asia and tropical Africa. Anti-allergic eye drops represent a consistently high-volume category in institutional and retail pharmacy channels across these regions, making them a strong commercial proposition for export buyers.
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Complete sterile ophthalmic documentation for market registration
All anti-allergic eye drops are manufactured in classified cleanrooms with aseptic fill-finish and supported by WHO-GMP Certificate, CoPP, batch CoA (sterility, particulate matter, pH, assay, preservative content), ICH Zone IVb stability data and CTD/ACTD dossiers on request — the complete package for market registration in semi-regulated and regulated markets.
MOLECULE CARDS
Key anti-allergic eye drops formulations at 9M India
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01
Olopatadine Eye Drops 0.1% w/v | Anti-allergic | 5ml / 10ml sterile bottle | Antihistamine + Mast cell stabiliser
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02
Ketotifen Eye Drops 0.025% w/v | Anti-allergic | 5ml sterile bottle | Antihistamine + Mast cell stabiliser
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03
Sodium Cromoglycate Eye Drops 2% w/v | Anti-allergic | 10ml sterile bottle | Mast cell stabiliser
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04
Azelastine Eye Drops 0.05% w/v | Anti-allergic | 6ml sterile bottle | Antihistamine
WHO WE SUPPLY
Export markets & regulatory readiness
9M India exports anti-allergic eye drops to 15+ countries across Phase 1 export markets including the UAE, Iraq, Egypt, Mexico, Kazakhstan, Sri Lanka and others in the Middle East, CIS, Africa and ASEAN. Allergic conjunctivitis is a high-prevalence condition in all our active export markets, making anti-allergic ophthalmic formulations a priority category for international supply.
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WHO-GMP Certificate
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DCGI Manufacturing Licence
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Certificate of Pharmaceutical Product (CoPP)
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Certificate of Analysis (CoA) — sterility, particulate matter, pH, assay — batch-wise
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CTD / ACTD Dossier — on request
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Stability Data — ICH Zone IVb (30°C/75% RH)
Partner with 9M India for anti-allergic eye drops eye drop supply
Whether you are sourcing Olopatadine, Ketotifen, Sodium Cromoglycate or other anti-allergic ophthalmic formulations — for institutional supply, government programmes or export distribution — 9M India delivers WHO-GMP certified sterile manufacturing with complete documentation and reliable supply at scale.
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WHO-GMP
Certified Facility -
In-House QC
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Contract &
3PM Available -
DCGI
Approved
Ophthalmic categories
Ophthalmic formulations across 11 categories
We keep answer short
Frequently Asked Questions
Find answers to the most common questions about our products, services, pricing, and policies.
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01
Yes. 9M India manufactures Olopatadine 0.1% w/v eye drops at its WHO-GMP certified sterile ophthalmic facility in Birkoni, Chhattisgarh. Olopatadine is a dual-acting antihistamine and mast cell stabiliser — the first-line treatment for allergic conjunctivitis globally. Manufactured under classified cleanroom conditions with aseptic fill-finish and sterility testing on every batch.
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02
Both Olopatadine and Ketotifen are dual-acting anti-allergic eye drops combining antihistamine and mast cell stabilising activity. Olopatadine (0.1%) is typically considered more potent with faster onset of action and is the more widely prescribed first-line agent. Ketotifen (0.025%) is effective for both seasonal and perennial allergic conjunctivitis and is available OTC in many markets. 9M India manufactures both formulations.
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03
Sodium Cromoglycate 2% is a mast cell stabiliser that works prophylactically — preventing degranulation of mast cells and histamine release before exposure to allergens. Unlike antihistamines which relieve symptoms after they occur, Sodium Cromoglycate must be started before allergen exposure to be effective. It is particularly useful for seasonal allergic conjunctivitis and vernal keratoconjunctivitis in children.
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04
Yes. Allergic conjunctivitis prevalence is significantly higher in the Middle East, North Africa and South Asia — due to high environmental allergen burden from dust, pollen and dry climate conditions. These are among 9M India's primary Phase 1 export markets, making anti-allergic eye drops a consistently high- volume export category. We supply to the UAE, Egypt, Iraq, Kazakhstan and others across these regions.
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05
Yes. Ketotifen 0.025% and Sodium Cromoglycate 2% eye drops are suitable for paediatric allergic conjunctivitis. Sodium Cromoglycate in particular is widely used in children due to its excellent safety profile. 9M India manufactures these formulations for institutional and export supply and can support paediatric ophthalmic programme procurement.
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06
Anti-allergic eye drops are available in 5ml and 10ml sterile multi-dose bottles as standard. Single-dose unit (SDU) preservative-free packaging can be arranged for formulations where preservative-free delivery is preferred — particularly for patients with preservative sensitivity. Please contact our export team for specific packaging requirements.
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07
Preservative-free formulations for anti-allergic eye drops can be developed on request. Preservative-free ophthalmic drops are increasingly preferred in markets where patients use multiple eye drop formulations simultaneously or have known preservative sensitivity. Please contact our team to discuss preservative- free formulation requirements for your market.
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08
Documentation available includes WHO-GMP Certificate, DCGI Manufacturing Licence, Certificate of Pharmaceutical Product (CoPP), batch-wise Certificate of Analysis (sterility, particulate matter, pH, assay, preservative content), ICH Zone IVb stability data and CTD/ACTD dossiers on request for all anti-allergic eye drop formulations.
