Loteprednol Etabonate 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. Loteprednol Etabonate is available in Drops / Gel/ Ointment and strengths such as 0.2%, 0.25%, 0.5%, 0.38%. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Loteprednol Etabonate is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.
| Technical Specifications & Supply Details | |
|---|---|
| Lead Time | 7 to 60 days (depending on batch size & schedule) |
| MOQ | As per manufacturer’s batch size |
| COA | Available with every batch |
| Regulatory Dossier / DMF | Available upon request |
| Export Documentation | FSC, COA, Manufacturing License, Product Permission |
| Standards | IP, BP, USP |
| Certifications | WHO-GMP, EU-GMP, USFDA (as applicable) |
Loteprednol Etabonate can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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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