Ambroxol oral solution bulk supplier for pharma manufacturers

Ambroxol Oral Solution Suppliers & Bulk Manufacturers

Available Forms: Syrup

Available Strengths: 15 mg/5 mL, 30 mg per 5 mL

Reference Brands: Mucosolvan(EU)

Category: Medical Aid

Ambroxol oral solution is available in Syrup and strengths such as 15 mg/5 mL, 30 mg per 5 mL. 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, Ambroxol oral solution 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)

Ambroxol oral solution 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: Ambroxol syrups are approved in the EU with comprehensive dossiers demonstrating safety, efficacy, and quality, supported by EMA regulations. In the US, Ambroxol is not officially approved but is available through imports or off-label use. Regulatory approval involves strict compliance with GMP standards and clinical evaluation. Well-established brands like Mucosolvan have extensive dossiers supporting their approval in Europe. For detailed regulatory information, approval status, and licensing processes for Ambroxol syrups, visit Pharmatradz. Stay informed on the latest regulatory developments and dossier requirements for Ambroxol products across global markets.

Frequently Asked Questions

Yes, Ambroxol oral solution 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, Ambroxol oral solution 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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