Product/Composition:- | Ambroxol oral solution |
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Strength:- | 15 mg/5 mL, 30 mg per 5 mL |
Form:- | Syrup |
Reference Brands:- | Mucosolvan(EU) |
MOQ | As per the manufacturer batch size |
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Ambroxol syrups work by stimulating mucus secretion and enhancing ciliary activity, aiding in mucus clearance. They also have anti-inflammatory effects. Benefits include improved coughing, reduced mucus viscosity, and better airway clearance, making them effective for respiratory conditions like bronchitis and COPD, and helping to alleviate breathing difficulties.
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.