Cefixime Tablets/Capsules

Form: Oral Tablets/Capsules

Strength: 200 mg, 400 mg

Reference Brands: Suprax(US & EU)

Category: Antibiotics

Cefixime tablets are approved in the EU and US for treating urinary tract and respiratory infections. In the EU, brands like Suprax 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 widely available. Both regions require detailed dossiers, including clinical trial results, manufacturing practices, and pharmacovigilance plans, for approval and ongoing safety monitoring. Due to widespread use, strict regulations on labeling, dosing, and usage are enforced. For expert assistance with regulatory dossiers, compliance, and registration, visit PharmaTradz. We support seamless market access, ensuring adherence to European and US standards for effective bacterial infection management.