Loteprednol Etabonate bulk supplier for pharma manufacturers

Loteprednol Etabonate 0.2%, 0.25%, 0.5%, 0.38% Suppliers & Bulk Manufacturers

Available Forms: Drops / Gel/ Ointment

Available Strengths: 0.2%, 0.25%, 0.5%, 0.38%

Reference Brands: Lotemax (USA/EU), Alrex (USA)

Loteprednol Etabonate is a corticosteroid used in ophthalmology for the treatment of inflammatory eye conditions such as allergic conjunctivitis, keratitis, post-operative inflammation, and seasonal ocular allergies. It is an ester-based corticosteroid, designed for rapid inactivation in the body, reducing the risk of long-term steroid side effects.

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Product Description:

Loteprednol etabonate is an ophthalmic corticosteroid designed around a specific safety objective. It is an ester-based steroid developed on retrometabolic principles: the molecule is engineered to exert its effect at the ocular surface and then be metabolised rapidly to inactive derivatives. The intended consequence is anti-inflammatory activity with a substantially reduced tendency to raise intraocular pressure compared with ketone-based corticosteroids such as dexamethasone and prednisolone acetate.

That property governs its use. Where treatment must extend beyond a short course — chronic allergic conjunctivitis, post-operative inflammation, or patients known to respond to steroids with pressure rises — loteprednol is frequently preferred despite higher cost.

It is supplied as ophthalmic suspension at 0.2% and 0.5%, as a gel at 0.38% and 0.5%, and as an ointment. The gel formulations were developed to improve retention and reduce the resuspension requirement of the older suspension.

Sourcing notes. Ophthalmic manufacture requires sterile approval specifically covering eye preparations, which is narrower than general sterile approval and must be confirmed at plant level. The gel presentations are technically more demanding than the suspension and are made by considerably fewer sites. Patent position varies by territory — verify freedom to operate in the destination market before committing to a registration pathway.

Loteprednol Etabonate — third party manufacturing & bulk supply

Loteprednol Etabonate 0.2%, 0.25%, 0.5%, 0.38% is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.

Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.

Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Loteprednol Etabonate is supplied as Drops / Gel/ Ointment — a dosage form priced by order value, so the indicative MOQ is a minimum order value of USD 5,000 per product. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Loteprednol Etabonate listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

Loteprednol Etabonate is used as a topical ophthalmic corticosteroid to treat inflammatory conditions of the eye such as the palpebral and bulbar conjunctiva, cornea and anterior segment (for example following ocular surgery or in allergic conjunctivitis) by reducing inflammation and associated symptoms.

Loteprednol Etabonate is the ester derivative of the corticosteroid loteprednol (chemical class: glucocorticoid) designed as a “soft-drug” which is converted in the body into inactive metabolites, thereby theoretically reducing systemic side-effects. The chemical formula for loteprednol etabonate is C₄₄H₅₄Cl₂O₁₆ (various sources show it as C24H31ClO7 in simplified form) and it's formulated into ophthalmic suspensions, gels or ointments.

Major trade names include “LOTEMAX®” (ophthalmic suspension, gel, ointment) and “ALREX®” (ophthalmic suspension) among others; there is also the fixed-dose combination with tobramycin marketed as “ZYLET®”.

The original innovator for LOTEMAX/ALREX is Bausch & Lomb Incorporated. Generic manufacturers also produce the generic loteprednol etabonate ophthalmic products; for example, Lupin Limited has a U.S. FDA-approved ANDA for loteprednol etabonate ophthalmic suspension 0.5 % and ophthalmic gel 0.38 %.

The generic name is

Brand names include LOTEMAX®, ALREX®, ZYLET® (combination with tobramycin) and others in various countries.

Manufacturing locations vary by manufacturer and product. For instance, Lupin’s approved generic is manufactured at their Pithampur facility in India.