Diclofenac Extended-Release Tablets

Form: Extended-Release Tablets

Strength: 100 mg

Reference Brands: Voltaren(US & EU)

Category: Arthritis

Diclofenac ER (Extended-Release) tablets are approved in the EU and US for managing chronic pain and inflammation. In the EU, brands like Voltaren ER are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and quality. In the US, FDA approval is based on comprehensive clinical data and biosimilarity assessments, with generic versions available. Both regions require detailed dossiers for approval and ongoing pharmacovigilance. For expert assistance with regulatory dossiers, compliance, and registration, visit PharmaTradz. We help facilitate efficient market access for diclofenac ER tablets, ensuring adherence to European and American standards for safe, effective long-term anti-inflammatory therapy.