Fluconazole Ophthalmic Solution (0.3% w/v)

Healthy Inc is a specialized global supplier and exporter of advanced ophthalmology, anti-infectives, and targeted antifungal therapeutics. We provide ultra-high-purity, kinetically stabilized Fluconazole Eye Drops, manufactured in WHO–GMP certified, high-precision sterile ophthalmic facilities. This “Bis-triazole Antifungal” is a strategic export to eye hospitals, surgical centers, and government health ministries, serving as the globally preferred intervention for the clinical management of keratomycosis and ocular candidiasis.

Product Overview

This formulation operates as a “Membrane Permeability Disruptor.” It physically targets the metabolic pathways unique to fungi, making it impossible for the pathogen to maintain its cellular integrity or replicate within the ocular tissue.

  • Mechanism 1 (14α-Demethylase Inhibition): Fluconazole physically inhibits the fungal cytochrome P450 enzyme 14α-demethylase.

  • Mechanism 2 (Ergosterol Depletion): By blocking this enzyme, it physically prevents the conversion of lanosterol to Ergosterol, the essential component of the fungal cell membrane.

  • Mechanism 3 (Cellular Collapse): The resulting lack of ergosterol leads to increased membrane permeability and leakage of intracellular contents, physically killing yeasts like Candida and certain filamentous fungi.


Product Composition & Strength

We supply this product in a Sterile, Buffered, Isotonic Aqueous Solution, optimized for high corneal penetration and ocular comfort.

Active IngredientStrength (w/v)Primary Clinical Function
Fluconazole USP/BP0.3% (3mg/mL)The Antifungal Specialist: Eradicates ocular yeast and fungi.
ExcipientsBenzalkonium Chloride / NaClThe Sterile Matrix: pH-balanced (pH 4.0–8.0).

Technical & Logistics Specifications

  • HS Code: 3004.20.19 (Medicaments containing other antibiotics – Antifungals)

  • CAS Number: 86386-73-4 (Fluconazole)

  • Dosage Form: Sterile Eye Drops (Ophthalmic Solution)

  • Packaging: Sterile LDPE Dropper Bottles (5ml). Our specialized ophthalmic packaging ensures 24-month stability in Zone IVb tropical climates.


Manufacturing Authority & Compliance

  • Aseptic Filling Excellence: Our manufacturing process utilizes Class 100 (ISO 5) Sterile Filling Lines. This ensures the solution is 100% free from microbial contaminants, a non-negotiable requirement for treating compromised corneal tissue.

  • Solubility Engineering: We utilize Advanced Solubilization Techniques to ensure the Fluconazole remains perfectly dissolved in the aqueous base, preventing precipitation and ensuring consistent dosing for every application.

Primary Indications

  • Ophthalmology: Treatment of Fungal Keratitis (Corneal infections) caused by Candida, Aspergillus, or Fusarium.

  • Surgery: Management of post-operative fungal endophthalmitis.

  • Specialized Care: Treatment of ocular candidiasis in immunocompromised patients.

Dosage & Administration

  • Standard Regimen: Typically 1 to 2 drops in the affected eye(s) every 2 to 4 hours, or as directed by an ophthalmologist.

  • Administration: Apply to the conjunctival sac. To minimize systemic absorption, the patient should apply pressure to the tear duct for 1 minute after instillation.

  • Duration: Fungal infections require long-term treatment; therapy may continue for several weeks to ensure total eradication.

Safety Warning: For Ophthalmic Use Only. Vision Warning: May cause temporary blurred vision; do not drive until vision is clear. Monitoring: Fungal eye infections are medical emergencies; regular follow-up with a specialist is mandatory. Contraindication: Do not use if known hypersensitivity to triazole antifungals exists.


Global Export & Contract Manufacturing

Healthy Inc is a premier Ophthalmic and Antifungal Pharmaceutical Exporter in India. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) for high-volume sterile antifungal eye drops. Whether you are a Specialized Eye Hospital in the Middle East or a B2B Pharma Marketplace partner in Africa, the CIS, or SE Asia, we ensure secure, WHO-GMP compliant delivery.

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