
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.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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.
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