carbamide peroxide ear drops bulk supplier for pharma manufacturers

Carbamide Peroxide Ear Drops Suppliers & Bulk Manufacturers

Available Forms: Ear drops

Available Strengths: 6.5%

Reference Brands: Debrox, Murine Earwax Removal Aid(US)

Category: ENT

carbamide peroxide ear drops is available in Ear drops and strengths such as 6.5%. 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, carbamide peroxide ear drops 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)

carbamide peroxide ear drops 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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Product Description: Carbamide peroxide ear drops, marketed as Debrox and Murine, are approved in the US by the FDA and in the EU via regional regulatory agencies for earwax softening and removal. Regulatory approval requires dossiers covering safety, ingredient sourcing, manufacturing practices, and efficacy data. The FDA reviews clinical safety and quality profiles, while the EMA ensures compliance with regional safety standards. For dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence supports timely approval, safe use, and broadglobal access, helping consumers effectively manage cerumen buildup and maintain ear health across healthcare regions worldwide.

Frequently Asked Questions

Yes, carbamide peroxide ear drops 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, carbamide peroxide ear drops 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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