Cyclosporine Eye Drops Manufacturer in India | 0.05% Ophthalmic Emulsion

What We Manufacture

About Cyclosporine Eye Drops — 9M India

9M India manufactures Cyclosporine 0.05% ophthalmic emulsion at its WHO-GMP certified sterile ophthalmic facility in Birkoni, Chhattisgarh. Cyclosporine ophthalmic emulsion is the only approved topical immunomodulator for chronic dry eye disease associated with ocular inflammation — and one of the most technically demanding ophthalmic formulations to manufacture, requiring oil-in-water emulsion technology with sub-micron particle size control for adequate corneal penetration. Unlike lubricant eye drops that address dry eye symptoms, Cyclosporine treats the underlying T-cell mediated inflammatory mechanism — suppressing immune damage to lacrimal gland tissue and allowing recovery of natural tear production. This specialty formulation is produced by relatively few manufacturers globally — giving 9M India a significant commercial differentiation in export markets.

Formulation specifications

Specification	Details
Molecule	Cyclosporine A
Concentration	0.05% w/v
Dosage Form	Sterile Ophthalmic Emulsion (Oil-in-Water)
Therapeutic Class	Immunomodulator — Calcineurin Inhibitor
Pack Options	3ml vials (unit-dose or multi-dose)
Preservative	Preservative-free formulation
Particle Size	Sub-micron emulsion droplets — critical quality attribute
pH Range	6.5 – 8.0
Storage	Store below 25°C, protect from light. Do not freeze.
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 Cyclosporine 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

Cyclosporine inhibits T-lymphocyte activation and proliferation — suppressing the T-cell mediated inflammatory cascade responsible for lacrimal gland damage in chronic dry eye disease. By reducing ocular surface inflammation, Cyclosporine allows recovery of lacrimal gland function and natural tear production over time. The oil-in-water emulsion formulation is essential for corneal penetration of this lipophilic molecule.

Primary Indications:

Chronic dry eye disease (keratoconjunctivitis sicca) — moderate to severe, with inflammatory component
Vernal keratoconjunctivitis (VKC) — refractory to antihistamines and corticosteroids
Atopic keratoconjunctivitis (AKC)
Superior limbic keratoconjunctivitis
Corneal graft rejection — prophylaxis (off-label in some centres)
Sjögren’s syndrome associated dry eye — immune-mediated

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Who We Supply

Export markets & regulatory readiness

9M India exports Cyclosporine ophthalmic emulsion to export markets where VKC and chronic inflammatory dry eye represent significant unmet clinical need — particularly the Middle East, South Asia and Africa where hot, dry climates and high allergen burden create high VKC prevalence. As a specialty formulation manufactured by limited global suppliers, Cyclosporine represents a strong commercial proposition for export partners seeking product differentiation.

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 Cyclosporine Eye Drops supply

Whether you are sourcing Cyclosporine ophthalmic emulsion for chronic dry eye management, VKC treatment or export distribution — 9M India delivers WHO-GMP certified specialty sterile manufacturing with complete documentation and the technical expertise that few manufacturers globally can match.

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

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Frequently asked questions — Cyclosporine Eye Drops

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

01

Yes. 9M India manufactures Cyclosporine 0.05% ophthalmic emulsion at its WHO-GMP certified sterile facility. This is a specialty oil-in-water emulsion requiring sub-micron particle size control — a technically demanding formulation produced by relatively few manufacturers globally. All batches undergo full sterility testing, particle size analysis and emulsion stability verification.
02

Lubricant eye drops (CMC, Hypromellose) provide symptomatic relief — temporary moisture and comfort. Cyclosporine 0.05% ophthalmic emulsion treats the underlying inflammatory cause of dry eye by suppressing T-cell mediated immune damage to lacrimal gland tissue — allowing recovery of natural tear production. It is indicated for moderate-to-severe inflammatory dry eye where lubricants alone are insufficient.
03

Cyclosporine 0.05% is instilled twice daily. Measurable improvements in tear parameters typically appear within 3 months. Maximum clinical benefit may take 6 months of consistent treatment. Patients commonly use lubricant eye drops concurrently for immediate symptom relief during this induction period.
04

Yes. Cyclosporine ophthalmic emulsion is effective for moderate-to-severe VKC refractory to standard antihistamines and corticosteroids. VKC is highly prevalent in hot, dry climates across Africa, the Middle East and South Asia — 9M India's primary export markets. This makes Cyclosporine particularly relevant for these regions where VKC burden is highest.
05

Cyclosporine ophthalmic emulsion requires oil-in-water emulsion technology with critical sub-micron particle size control — a significantly more complex manufacturing process than standard ophthalmic solutions. Fewer manufacturers globally produce this formulation under WHO-GMP conditions, giving 9M India a commercial advantage and export partners a differentiated product not easily sourced elsewhere.
06

Documentation available includes WHO-GMP Certificate, DCGI Manufacturing Licence, CoPP, batch-wise CoA (sterility, particulate matter, pH, assay, particle size analysis), ICH Zone IVb stability data including emulsion stability parameters, and CTD/ACTD dossiers on request. Our regulatory team provides specialist support for this formulation.

Cyclosporine Eye Drops (Ophthalmic Emulsion) Manufacturer in India