Amoxicillin + Potassium Clavulanate Suspension

Form: Suspension

Strength: 125 mg/31.25 mg per 5 mL, 250 mg/62.5 mg per 5 mL, 400 mg/57 mg per 5 mL

Reference Brands: Augmentin(US)

Category: Antibiotics

Amoxicillin Potassium Clavulanate suspension is approved in the EU and US for treating bacterial infections, especially those caused by beta-lactamase-producing bacteria. In the EU, brands like Augmentin are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, FDA approval is based on extensive clinical data, with generic options available. Both regions require detailed dossiers and pharmacovigilance plans for initial approval and ongoing safety monitoring. For expert assistance with regulatory dossiers, compliance, and registration, visit PharmaTradz. We support seamless market access for amoxicillin-clavulanate suspension, ensuring adherence to European and US standards for safe, effective antibiotic therapy.