Miotic, Diagnostic & Decongestant Eye Drops Manufacturer in India

WHO-GMP certified sterile ophthalmic manufacturing — Pilocarpine miotics, Fluorescein diagnostic drops and Naphazoline decongestant eye drops — for ophthalmic clinical use, diagnostic procedures and symptomatic relief.

Key Highlights

WHO-GMP
Certified Sterile Ophthalmic Facility
Classified Cleanroom
— Aseptic Fill-Finish
DCGI Approved
Formulations
15+ Countries
Supplied

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What We Manufacture

Miotic, Diagnostic & Decongestant eye drop manufacturing at 9M India

9M India manufactures miotic, diagnostic and decongestant eye drops at its WHO-GMP certified sterile ophthalmic facility in Birkoni, Chhattisgarh. This category covers three distinct and clinically important groups of ophthalmic formulations. Miotics — principally Pilocarpine — constrict the pupil and are used in the management of glaucoma and to reverse mydriasis. Diagnostic agents — particularly Fluorescein — are essential staining and imaging tools in ophthalmic clinical practice, used for corneal examination, fluorescein angiography and contact lens fitting. Decongestants — such as Naphazoline — provide symptomatic relief for ocular redness and minor conjunctival irritation. All formulations are manufactured under classified cleanroom conditions with aseptic fill-finish and complete regulatory documentation.

Formulations — Miotic / Diagnostic / Decongestant Eye Drops

Our miotic / diagnostic / decongestant eye drops eye drop range covers the following molecules and formulations:

Molecule / Formulation	Details
Pilocarpine Nitrate Eye Drops	1% w/v, 2% w/v, 4% w/v — Cholinergic miotic. Used for open-angle glaucoma, reversal of mydriasis post-procedure.
Fluorescein Eye Drops	1% w/v, 2% w/v — Diagnostic dye. Corneal abrasion / ulcer staining, fluorescein angiography, contact lens fitting assessment.
Naphazoline Eye Drops	0.012% / 0.1% w/v — Sympathomimetic decongestant. Symptomatic relief of ocular redness and minor conjunctival congestion.
Phenylephrine Eye Drops (Decongestant dose)	0.12% w/v — Mild adrenergic decongestant for conjunctival redness relief.

Sterile ophthalmic manufacturing at 9M India

All eye drops manufactured by 9M India — including miotic / diagnostic / decongestant 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 miotic / diagnostic / decongestant eye drops eye drops

Pilocarpine — a WHO Essential Medicine for glaucoma

Pilocarpine nitrate is listed on the WHO Model List of Essential Medicines for the management of glaucoma. It remains a widely used first-line or adjunct antiglaucoma agent in resource-limited settings across Africa, ASEAN and CIS — markets where beta-blocker or prostaglandin analogue access may be limited or cost-prohibitive. 9M India manufactures Pilocarpine eye drops in 1%, 2% and 4% strengths under WHO-GMP conditions at scale.
Fluorescein — essential for every ophthalmology unit

Fluorescein eye drops are a fundamental diagnostic tool in ophthalmic clinical practice — used for corneal epithelial defect staining, contact lens fitting assessment and pre-angiography dye preparation. No ophthalmology department functions without it. 9M India manufactures Fluorescein 1% and 2% eye drops under sterile conditions with complete batch documentation.
Decongestant eye drops for OTC and institutional supply

Naphazoline and low-dose Phenylephrine decongestant eye drops address ocular redness from environmental irritants, minor allergic reactions and contact lens wear — generating consistent high-volume OTC demand in retail pharmacy and institutional channels across all export markets.

MOLECULE CARDS

Key miotic / diagnostic / decongestant eye drops formulations at 9M India

01

Pilocarpine Nitrate Eye Drops 1% w/v | Miotic | 5ml sterile bottle | Cholinergic — glaucoma / reverse mydriasis
02

Pilocarpine Nitrate Eye Drops 2% w/v | Miotic | 5ml sterile bottle | Cholinergic — glaucoma / reverse mydriasis
03

Pilocarpine Nitrate Eye Drops 4% w/v | Miotic | 5ml sterile bottle | Cholinergic — higher concentration glaucoma
04

Fluorescein Eye Drops 1% w/v | Diagnostic | 5ml sterile bottle | Corneal staining / diagnostic dye
05

Fluorescein Eye Drops 2% w/v | Diagnostic | 5ml sterile bottle | Corneal staining / fluorescein angiography
06

Naphazoline Eye Drops 0.012% w/v | Decongestant | 10ml sterile bottle | Sympathomimetic — ocular redness relief
07

Naphazoline Eye Drops 0.1% w/v | Decongestant | 10ml sterile bottle | Sympathomimetic — ocular redness

WHO WE SUPPLY

Export markets & regulatory readiness

9M India exports miotic, diagnostic and decongestant eye drops to 15+ countries across Phase 1 markets including the UAE, Iraq, Egypt, Mexico, Kazakhstan, Sri Lanka and others in the Middle East, CIS, Africa and ASEAN. Pilocarpine (a WHO Essential Medicine), Fluorescein (essential diagnostic) and Naphazoline (high-volume OTC decongestant) represent consistent export demand across all active markets.

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 miotic / diagnostic / decongestant eye drops eye drop supply

Whether you are sourcing Pilocarpine miotics for glaucoma programmes, Fluorescein for diagnostic ophthalmic supply or Naphazoline decongestant eye drops for retail and institutional channels — 9M India delivers WHO-GMP certified sterile manufacturing with complete documentation and reliable export supply.

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

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Ophthalmic categories

Ophthalmic formulations across 11 categories

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Frequently Asked Questions

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

01

Yes. 9M India manufactures Pilocarpine Nitrate eye drops in 1%, 2% and 4% strengths at its WHO-GMP certified sterile ophthalmic facility. Pilocarpine is a WHO Essential Medicine for glaucoma management — a cholinergic miotic that reduces intraocular pressure by increasing aqueous outflow through the trabecular meshwork. All three strengths are available for institutional and export supply with complete GMP documentation.
02

Pilocarpine has several important ophthalmic applications: management of open-angle glaucoma (reduces IOP), emergency treatment of acute angle-closure glaucoma (rapid miosis to open angle), reversal of pharmacologically induced mydriasis (pupil constriction after diagnostic dilation), and Adie's pupil diagnosis. The 1% and 2% concentrations are most commonly used, with 4% reserved for acute angle-closure emergencies.
03

Fluorescein sodium eye drops (1% and 2%) are essential diagnostic staining agents in ophthalmology. They fluoresce bright green under cobalt blue light and are used for: corneal epithelial defect and ulcer detection (abrasions, infections, foreign bodies), Seidel test to detect aqueous leakage from corneal wounds, contact lens fitting and assessment, tear film break-up time measurement, and as a precursor for intravenous fluorescein angiography preparation.
04

Naphazoline is a sympathomimetic alpha-adrenergic agonist that causes vasoconstriction of conjunctival blood vessels — providing rapid relief from ocular redness (red eye) due to environmental irritants, smoke, dust, wind exposure, swimming, minor allergic reactions and contact lens wear. It is available OTC in many markets. 9M India manufactures Naphazoline eye drops in 0.012% and 0.1% concentrations for both institutional and retail/OTC supply.
05

Pilocarpine works through the same mechanism in both roles — stimulating muscarinic receptors causing ciliary muscle contraction and iris sphincter constriction (miosis). In glaucoma management, the ciliary muscle contraction stretches the trabecular meshwork, increasing aqueous outflow and reducing intraocular pressure. As a miotic, the primary observed effect is pupil constriction — used to reverse mydriasis or narrow a pathologically dilated pupil.
06

Fluorescein eye drops are generally very well tolerated. Transient mild stinging on instillation is common. Temporary yellow discolouration of the tear film and periocular skin normalises within minutes. Serious adverse effects are extremely rare. Fluorescein must not be used in contact lens wearers without lens removal — it permanently stains soft contact lenses. 9M India manufactures Fluorescein in sterile, buffered formulations for optimal ocular tolerability.
07

Yes. Pilocarpine is a WHO Essential Medicine and is in consistent high demand across Africa, South Asia and the Middle East — where glaucoma is a major cause of preventable blindness and prostaglandin analogues may not be accessible or affordable for all patients. 9M India manufactures Pilocarpine at scale for institutional export supply to national blindness prevention programmes and hospital ophthalmology departments across these regions.
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), ICH Zone IVb stability data and CTD/ACTD dossiers on request for Pilocarpine, Fluorescein and Naphazoline eye drop formulations. Multi-lingual labelling for destination markets is available on request.