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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)

Category: Allergy Medication

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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📘 Sourcing Guide

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.

What to include when you enquire

  • Destination market — determines which manufacturers hold the right site-level approvals
  • First order quantity and estimated annual volume
  • Whether you need a registration dossier or the product is already registered
  • Packaging, labelling and language requirements
  • Incoterms and required 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. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.

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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.

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