Tropicamide Eye Drops Manufacturer in India

What We Manufacture

About Tropicamide Eye Drops — 9M India

9M India manufactures Tropicamide eye drops in 0.5% and 1.0% w/v strengths at its WHO-GMP certified sterile ophthalmic facility in Birkoni, Chhattisgarh. Tropicamide is the most widely used short-acting anticholinergic mydriatic eye drop globally — an essential formulation in every ophthalmology department. Its primary use is pupil dilation for fundus examination and retinal screening, cycloplegic refraction in adults and older children, and pre-operative mydriasis before cataract surgery. Tropicamide is particularly critical for diabetic retinopathy screening programmes — a major institutional demand driver across all 9M India’s export markets where diabetes prevalence is highest. With short onset (15-20 minutes) and short duration of action (4-6 hours), it allows patients to return to normal activities the same day.

Formulation specifications

Specification	Details
Molecule	Tropicamide
Available Concentrations	0.5% w/v · 1.0% w/v
Dosage Form	Sterile Ophthalmic Solution
Therapeutic Class	Mydriatic / Cycloplegic — Anticholinergic
Pack Options	5ml sterile multi-dose bottle
Onset of Action	15–20 minutes
Duration of Action	4–6 hours
pH Range	4.0 – 5.8
Storage	Store below 25°C, protect from light
Shelf Life	24 months
Pharmacopoeial Standard	BP / USP / IP
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 Tropicamide 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

Tropicamide is an anticholinergic (muscarinic receptor antagonist) that blocks acetylcholine at the iris sphincter and ciliary muscle, causing pupil dilation (mydriasis) and paralysis of accommodation (cycloplegia). Its short duration of action — significantly shorter than Atropine or Homatropine — makes it the preferred agent for diagnostic mydriasis where rapid recovery of normal vision is clinically important.

Primary Indications:

Fundus examination — retinal screening and assessment
Diabetic retinopathy screening — the primary use in large-volume screening programmes
Fundus photography and optical coherence tomography (OCT) requiring dilated pupil
Cycloplegic refraction in adults and older children
Pre-operative mydriasis before cataract surgery (combined with Phenylephrine 10%)
Fluorescein angiography — requiring dilated pupil
Intraocular lens (IOL) power calculation requiring dilated fundus examination

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Who We Supply

Export markets & regulatory readiness

9M India exports Tropicamide 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. Tropicamide is an essential medicine for every hospital ophthalmology department and is in particularly high demand for diabetic retinopathy screening programmes — a priority health programme across all active export markets due to the high diabetes burden in these regions.

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 Tropicamide Eye Drops supply

Whether you are sourcing Tropicamide eye drops for hospital ophthalmology departments, diabetic retinopathy screening programmes, government cataract surgery 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
Contract &
3PM Available
DCGI
Approved

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Frequently asked questions — Tropicamide Eye Drops

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

01

Yes. 9M India manufactures Tropicamide eye drops in 0.5% and 1.0% w/v strengths at its WHO-GMP certified sterile ophthalmic facility in Birkoni, Chhattisgarh. All batches are produced under classified cleanroom conditions with aseptic fill-finish, sterility testing and complete batch documentation. DCGI approved and export-ready for 15+ countries.
02

Tropicamide 0.5% provides adequate mydriasis for routine fundus examination in most patients with slightly shorter duration and lower cycloplegic effect. Tropicamide 1% provides stronger, more complete mydriasis and cycloplegia — preferred for heavily pigmented irides, pre-operative dilation and when cycloplegic refraction is required in adults. 9M India manufactures both strengths for complete formulary coverage.
03

Tropicamide is preferred for routine fundus examination because its duration of action is 4-6 hours — patients recover normal vision the same day. Atropine causes pupil dilation lasting several days — impractical for routine diagnostic procedures. Tropicamide provides sufficient dilation for most diagnostic purposes with minimal patient inconvenience.
04

Yes. Tropicamide 0.5% or 1% is the standard mydriatic for diabetic retinopathy screening globally. Dilated fundus examination after Tropicamide is the primary method for detecting diabetic retinopathy at population scale. With the enormous diabetes burden in South Asia, Africa and the Middle East, diabetic eye screening programmes represent a major institutional demand driver for Tropicamide in all 9M India's export markets.
05

Yes. The combination of Tropicamide (anticholinergic) and Phenylephrine 10% (adrenergic) provides maximum pupil dilation through two complementary pathways. This combination is the standard protocol for pre-operative mydriasis before cataract surgery and for difficult-to-dilate pupils. 9M India manufactures both Tropicamide and Phenylephrine 10% eye drops for this combination use.
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. Tropicamide eye drops are part of 9M India's active ophthalmic export portfolio with established dossiers for multiple markets.