Fluorometholone 0.1% Suppliers & Bulk Manufacturers

Available Forms: Drops/ Ophthalmic Ointment

Available Strengths: 0.1%

Reference Brands: FML (USA/EU/UK), Flarex (USA)

Category: Allergy Medication

Fluorometholone (FML) is a corticosteroid used in ophthalmology for the treatment of inflammatory and allergic eye conditions, including allergic conjunctivitis, keratitis, iritis, and post-operative inflammation. It works by reducing ocular inflammation, redness, and irritation.

Product Description:

Fluorometholone is a topical ophthalmic corticosteroid, and its clinical position rests on a favourable safety characteristic rather than superior potency. Its fluorinated structure and limited corneal penetration give it a materially lower propensity to raise intraocular pressure than dexamethasone or prednisolone acetate. For treatment courses extending beyond a few days — and particularly in patients who respond to steroids with pressure rises — that difference determines the choice of agent.

It is supplied as an ophthalmic suspension, typically 0.1%, and as an ointment. The suspension requires resuspension before instillation, and consistency of particle size distribution is a genuine quality attribute rather than a formality, since it governs dose uniformity.

Sourcing notes. Ophthalmic manufacture is a specialised capability requiring sterile approval specifically covering ophthalmic preparations; a plant approved for general sterile products is not automatically approved for eye preparations, and this is a common and expensive misunderstanding at audit stage. Confirm the scope explicitly. Preservative system also warrants attention: benzalkonium chloride remains standard but faces restriction in several markets and growing resistance from prescribers, and preservative-free unit-dose presentations command a premium where they are accepted.