Ambroxol Oral Solution 15 mg/5 mL, 30 mg/5 mL Suppliers & Bulk Manufacturers

Available Forms: Oral solution / syrup

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

Reference Brands: Mucosolvan(EU)

Category: Respiratory Disorder

Ambroxol oral solution and syrup, 15 mg/5 mL and 30 mg/5 mL, a secretolytic for productive cough. Listed for importers, distributors and pharmacies sourcing paediatric and adult liquid formulations.

Product Description:

Ambroxol hydrochloride is a secretolytic mucolytic and an active metabolite of bromhexine. It increases the watery part of bronchial secretions, stimulates surfactant release and improves ciliary action, so mucus is easier to cough up. This page covers syrup and oral solution at 15 mg/5 mL and 30 mg/5 mL. The lower strength is mostly for children, dosed by age, and the higher for adults. A liquid suits people who cannot swallow tablets and allows fine dose steps with a cup or oral syringe.

It is used for acute and chronic bronchopulmonary conditions with thick or excessive mucus. In many European markets it is a pharmacy medicine without prescription; elsewhere it may be prescription-only, and it is not an approved medicine in the United States. A European safety review found a low risk of severe allergic and skin reactions, so labels advise stopping at once if a rash appears. Use in very young children is restricted in some countries. Sorbitol-sweetened versions are unsuitable in hereditary fructose intolerance.

Sourcing notes. Specify strength, bottle size, sugar-free or sucrose base, flavour, preservative system and measuring device. Bottles are usually amber glass or PET, with child-resistant caps where required. Stability data should cover the bottle as sold and the in-use period after opening, at zone IVb for tropical markets. Dossiers are commonly CTD, or ACTD in South-East Asia. Ask for a CoA for every batch, the GMP certificate and a CoPP, and check that hypersensitivity wording matches the current reference text in your market.