Cefalexin (1st Gen) Capsules and tablets

Form: Oral Capsules and Tablets

Strength: 250 mg, 500 mg

Reference Brands: Keflex(US & EU)

Category: Antibiotics

Cephalexin oral capsules and tablets are approved across the EU and US for treating bacterial infections such as skin, respiratory, and urinary tract infections. In the EU, brands like Keflex and generic formulations 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 readily available. Both regions require detailed dossiers including clinical trial results, quality control, and pharmacovigilance plans for initial approval and safety monitoring. For expert support with regulatory dossiers, compliance, and registration, visit PharmaTradz. We support seamless market access, ensuring adherence to European and US standards for safe, effective use.