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At 9M India Limited, trust through quality, transparency, performance.
Immunomodulator Eye Drop Manufacturer in India
WHO-GMP certified sterile manufacturing of Cyclosporine ophthalmic emulsion — the gold standard immunomodulatory therapy for chronic dry eye disease and vernal keratoconjunctivitis.
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
Our Immunomodulator Ophthalmic eye drop range
Cyclosporine ophthalmic emulsion is one of the most technically sophisticated ophthalmic formulations — an oil-in-water cationic emulsion requiring specialised manufacturing capability. Key formulations:
- Cyclosporine 0.05% Ophthalmic Emulsion (Cationic) — FDA/DCGI approved for chronic dry eye disease (Keratoconjunctivitis sicca)
- Cyclosporine 0.1% Ophthalmic Emulsion — For vernal keratoconjunctivitis and severe dry eye
- Cyclosporine 0.5% Ophthalmic Solution — For prevention of corneal graft rejection
- Tacrolimus 0.03% · 0.1% Ophthalmic — For severe vernal keratoconjunctivitis
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WHY 9M INDIA
Cyclosporine ophthalmic emulsion — a technically advanced specialty formulation at 9M India
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Sterile ophthalmic manufacturing — classified cleanroom
All ophthalmic preparations at 9M India are manufactured in dedicated sterile cleanroom environments — Grade A fill-finish under Class A laminar airflow, with Grade B background. Environmental monitoring, water for injection (WFI) system validation, 0.22 micron sterile filtration and 100% container closure integrity testing are standard on every batch. No ophthalmic product is manufactured outside these conditions.
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In-house ophthalmic QC — specialised testing
Sterility · Bacterial endotoxins · Visible particulate matter · Sub-visible particles · pH · Osmolality · Assay (HPLC) · Preservative content · Container closure integrity — all tested in our dedicated ophthalmic QC laboratory. COA issued per batch.
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Complete documentation within 24 hours
DCGI manufacturing licence · WHO-GMP Certificate · COA · COC · Stability data (ICH Zone II and IVa) · Compatibility studies — available within 24 hours for tender, export registration or CDMO requirements.
WHO WE SUPPLY
Who sources immunomodulator ophthalmic eye drops from 9M India
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Ophthalmology departments & eye hospitals
Ophthalmologists specialising in corneal disease, dry eye and ocular allergy — Cyclosporine eye drops are expensive branded products; a WHO-GMP generic significantly improves patient access.
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Private label & contract manufacturing partners
Domestic ophthalmic brands seeking to launch Cyclosporine generics — 9M India's capability in cationic ophthalmic emulsion manufacturing provides a significant competitive advantage.
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International export buyers
All export markets — Cyclosporine 0.05% ophthalmic emulsion is one of the highest-value ophthalmic generics available with brand products priced at ₹500–1000 per bottle.
Need Cyclosporine ophthalmic emulsion manufactured under your brand?
Share your requirement — molecule, concentration, pack size and target market. We confirm manufacturing capability, documentation and lead times within 24 hours.
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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 Cyclosporine ophthalmic emulsion at its WHO-GMP certified sterile ophthalmic facility in Birkoni, Chhattisgarh. Cyclosporine is the only approved topical immunomodulator for chronic dry eye disease and is one of the most technically demanding ophthalmic formulations — requiring oil-in-water emulsion technology with precise particle size control for effective corneal penetration.
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02
Cyclosporine 0.05% ophthalmic emulsion is approved for the treatment of chronic dry eye disease (keratoconjunctivitis sicca) associated with ocular inflammation — addressing the underlying T-cell mediated inflammatory mechanism rather than just providing symptomatic lubrication. It is also used in severe vernal keratoconjunctivitis, corneal graft rejection prophylaxis and other immune-mediated ocular surface conditions.
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03
Standard lubricant eye drops (CMC, Hypromellose) treat the symptoms of dry eye — providing temporary moisture and comfort. Cyclosporine ophthalmic emulsion treats the underlying cause of inflammatory dry eye — suppressing the T-cell mediated immune response that damages lacrimal gland tissue and reduces tear production. Cyclosporine is indicated for moderate-to-severe dry eye with an inflammatory component, where lubricants alone provide insufficient relief.
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04
Cyclosporine ophthalmic emulsion is among the most technically complex ophthalmic formulations to manufacture — requiring oil-in-water emulsion technology with critical particle size control (sub-micron droplets) for adequate corneal penetration. Fewer manufacturers globally have this capability compared to standard eye drop production. This creates a significant market differentiation for 9M India and premium pricing opportunity for export partners.
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05
In addition to Cyclosporine ophthalmic emulsion, 9M India manufactures Tacrolimus ophthalmic ointment (0.03%, 0.1%) for severe vernal keratoconjunctivitis and atopic keratoconjunctivitis — conditions where Cyclosporine may be insufficient. Tacrolimus is a calcineurin inhibitor with similar immunosuppressive mechanism but higher potency, used in refractory cases.
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06
Yes. Chronic dry eye with an inflammatory component is highly prevalent across the Middle East, South Asia and Africa — particularly in urban populations with high air conditioning exposure, contact lens use and increasing screen time. Vernal keratoconjunctivitis — a severe allergic inflammatory eye condition for which Cyclosporine is indicated — is especially prevalent in hot, dry climates across Africa, the Middle East and South Asia.
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07
Documentation available includes WHO-GMP Certificate, DCGI Manufacturing Licence, CoPP, batch- wise CoA (sterility, particulate matter, pH, assay, particle size analysis for emulsion), ICH Zone IVb stability data, emulsion characterisation data and CTD/ACTD dossiers on request. Our regulatory team can support market registration for this specialty formulation across semi-regulated and regulated export markets.
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08
Cyclosporine 0.05% ophthalmic emulsion is typically instilled twice daily. Therapeutic effect on tear production and inflammatory markers may take 3–6 months of consistent use to reach maximum benefit. Long-term continuous use is often required for chronic dry eye disease management. Patients may use lubricant eye drops concurrently for immediate symptom relief while waiting for Cyclosporine's therapeutic effect to develop.
