Loteprednol Etabonate bulk supplier for pharma manufacturers

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 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.

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Frequently Asked Questions

What is Loteprednol Etabonate made from? 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.

What is the trade name of Loteprednol Etabonate? 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®”.

What company makes Loteprednol Etabonate? 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 %.

What is the generic name of Loteprednol Etabonate? The generic name is Loteprednol Etabonate. 

What is the brand name of Loteprednol Etabonate? Brand names include LOTEMAX®, ALREX®, ZYLET® (combination with tobramycin) and others in various countries.

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

Yes, Loteprednol Etabonate is available with DMF and other regulatory documents such as COA and MSDS. These can be provided upon request for qualified buyers.

Absolutely. Sample requests are accepted for formulation trials and quality checks. Please submit an enquiry to initiate the process.

Our manufacturing partners are GMP-certified and comply with ISO and WHO standards, ensuring global quality benchmarks.

Lead times vary based on quantity and destination, but most orders are fulfilled within 1–3 weeks. Express shipping options are available.

Yes, Loteprednol Etabonate is exported to over 30 countries across Asia, Africa, Europe, and Latin America. We support documentation for customs and regulatory clearance.

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