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Mydriatic & Cycloplegic Eye Drops Manufacturer in India
WHO-GMP certified sterile mydriatic and cycloplegic ophthalmic manufacturing — Atropine, Tropicamide, Cyclopentolate and Homatropine eye drops — for ophthalmic diagnostic use, surgical preparation and therapeutic indications.
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
Mydriatic & Cycloplegic eye drop manufacturing at 9M India
9M India manufactures mydriatic and cycloplegic eye drops at its WHO-GMP certified sterile ophthalmic facility in Birkoni, Chhattisgarh. Mydriatic agents dilate the pupil and cycloplegics additionally paralyse the ciliary muscle — both are essential in ophthalmic diagnostic examination, pre-surgical preparation and therapeutic management of uveitis and amblyopia. These formulations are essential medicines for any hospital ophthalmology department and represent consistent demand in institutional, government hospital and export markets. Our portfolio includes Atropine (0.5%, 1%), Tropicamide (0.5%, 1%), Cyclopentolate (1%, 2%) and Homatropine (1%, 2%) eye drops — manufactured under classified cleanroom conditions with aseptic fill-finish and full regulatory documentation.
Formulations — Mydriatic & Cycloplegic Eye Drops
Our mydriatic & cycloplegic eye drops eye drop range covers the following molecules and formulations:
| Molecule / Formulation | Details |
| Atropine Eye Drops | 0.1% w/v, 0.5% w/v, 1.0% w/v — Long-acting anticholinergic mydriatic / cycloplegic. Used for refraction in children, uveitis, amblyopia treatment. |
| Tropicamide Eye Drops | 0.5% w/v, 1.0% w/v — Short-acting mydriatic. Standard agent for fundus examination and diagnostic dilation. |
| Cyclopentolate Eye Drops | 1% w/v, 2% w/v — Moderate-acting cycloplegic. Preferred for cycloplegic refraction, especially in children. |
| Homatropine Eye Drops | 1% w/v, 2% w/v — Intermediate-acting cycloplegic mydriatic. Used for uveitis management and cycloplegic refraction. |
| Phenylephrine Eye Drops | 10% w/v — Adrenergic mydriatic (no cycloplegia). Used alone or in combination for maximum pupil dilation pre-surgery. |
Sterile ophthalmic manufacturing at 9M India
All eye drops manufactured by 9M India — including mydriatic & cycloplegic 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 mydriatic & cycloplegic eye drops eye drops
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Essential for every hospital ophthalmology department
Mydriatic and cycloplegic eye drops are non-negotiable in any ophthalmology unit — for retinal examination, cataract pre-op assessment, cycloplegic refraction and uveitis management. 9M India manufactures the complete range of these essential agents under WHO-GMP sterile conditions, making us a reliable single-source supplier for institutional ophthalmic formularies.
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Multiple duration options — short, intermediate and long-acting
9M India manufactures the full spectrum of mydriatic / cycloplegic agents by duration of action: Tropicamide (short-acting, 4–6 hours) for routine diagnostic dilation; Cyclopentolate and Homatropine (intermediate, 12–24 hours) for cycloplegic refraction; and Atropine (long-acting, up to 14 days) for uveitis management and amblyopia treatment in children. All available for export.
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Paediatric ophthalmic demand in export markets
Cycloplegic refraction using Atropine 1% eye drops is the standard of care for accurate refractive error assessment in children — a high-volume requirement in government child eye health programmes across South Asia, Africa and ASEAN. 9M India manufactures Atropine eye drops at scale with full GMP documentation for institutional and government supply.
MOLECULE CARDS
Key mydriatic & cycloplegic eye drops formulations at 9M India
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01
Atropine Eye Drops 0.1% w/v | Mydriatic / Cycloplegic | 5ml sterile bottle | Anticholinergic — long-acting
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02
Atropine Eye Drops 0.5% w/v | Mydriatic / Cycloplegic | 5ml sterile bottle | Anticholinergic — long-acting
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03
Atropine Eye Drops 1.0% w/v | Mydriatic / Cycloplegic | 5ml sterile bottle | Anticholinergic — long-acting
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04
Tropicamide Eye Drops 0.5% w/v | Mydriatic | 5ml sterile bottle | Anticholinergic — short-acting
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05
Tropicamide Eye Drops 1.0% w/v | Mydriatic | 5ml sterile bottle | Anticholinergic — short-acting
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06
Cyclopentolate Eye Drops 1% w/v | Cycloplegic | 5ml sterile bottle | Anticholinergic — moderate-acting
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07
Cyclopentolate Eye Drops 2% w/v | Cycloplegic | 5ml sterile bottle | Anticholinergic — moderate-acting
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08
Homatropine Eye Drops 1% w/v | Mydriatic / Cycloplegic | 5ml sterile bottle | Anticholinergic — intermediate
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09
Homatropine Eye Drops 2% w/v | Mydriatic / Cycloplegic | 5ml sterile bottle | Anticholinergic — intermediate
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10
Phenylephrine Eye Drops 10% w/v | Mydriatic | 5ml sterile bottle | Adrenergic — no cycloplegia
WHO WE SUPPLY
Export markets & regulatory readiness
9M India exports mydriatic and cycloplegic 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. These are essential medicines for hospital ophthalmology departments and government eye health programmes in all our active export markets.
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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 mydriatic & cycloplegic eye drops eye drop supply
Whether you are sourcing Atropine, Tropicamide, Cyclopentolate or Phenylephrine eye drops — for hospital ophthalmology departments, government child eye health programmes, surgical supply or export distribution — 9M India delivers WHO-GMP certified sterile manufacturing with complete documentation and reliable supply.
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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
A mydriatic dilates the pupil by relaxing the iris sphincter or stimulating the iris dilator muscle. A cycloplegic additionally paralyses the ciliary muscle — preventing accommodation (focusing). All anticholinergic agents 9M India manufactures (Atropine, Tropicamide, Cyclopentolate, Homatropine) are both mydriatic and cycloplegic. Phenylephrine is a pure mydriatic with no cycloplegic effect — acting via the adrenergic pathway.
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02
Tropicamide 0.5% or 1% is the standard mydriatic for routine fundus (retinal) examination due to its rapid onset (15–20 minutes) and short duration of action (4–6 hours), allowing patients to recover normal vision within a few hours. For maximum dilation in dense cataracts or small pupils, Tropicamide is often combined with Phenylephrine 10%. 9M India manufactures both formulations under WHO-GMP sterile conditions.
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03
Atropine 1% eye drops — applied once daily for 3 days before examination — is the gold standard for cycloplegic refraction in young children (under 7 years) with suspected high hyperopia or amblyopia. It provides the most complete and prolonged cycloplegia (up to 14 days). Cyclopentolate 1% is preferred for older children due to its shorter duration (24 hours). 9M India manufactures both in all standard strengths.
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04
Atropine eye drops have several important clinical uses: cycloplegic refraction in children, uveitis management (preventing posterior synechiae formation), amblyopia treatment (patching the good eye with Atropine penalisation of the better eye), and myopia control — low-dose Atropine 0.01% is now widely used to slow myopia progression in children. 9M India manufactures Atropine in 0.1%, 0.5% and 1.0% strengths.
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05
Yes. 9M India manufactures Cyclopentolate eye drops in 1% and 2% strengths. Cyclopentolate is the preferred cycloplegic for children above 6 years and adults requiring cycloplegic refraction — with a moderate duration of 12–24 hours balancing thoroughness of cycloplegia with acceptable recovery time. The 2% formulation is used in heavily pigmented irides requiring stronger cycloplegia.
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06
Yes. Tropicamide and Phenylephrine are essential pre-operative agents for cataract surgery and other intraocular procedures requiring pupil dilation. 9M India manufactures these formulations for institutional surgical supply and can provide complete GMP documentation, CoPP and batch CoA for hospital procurement programmes. Large-volume institutional packaging is available.
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07
Homatropine is an intermediate-duration anticholinergic mydriatic and cycloplegic — onset in 30–60 minutes with duration of 12–36 hours, shorter than Atropine (days) but longer than Tropicamide (hours). It is used for cycloplegic refraction in adults, uveitis management where prolonged Atropine cycloplegia is not required, and in some post-operative settings. 9M India manufactures Homatropine 1% and 2% eye drops.
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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), ICH Zone IVb stability data and CTD/ACTD dossiers on request for all mydriatic and cycloplegic eye drop formulations including Atropine, Tropicamide, Cyclopentolate, Homatropine and Phenylephrine.
