Hydroxychloroquine tablets

Form: Tablets

Strength: 200 mg

Reference Brands: Plaquenil(US & EU)

Category: Arthritis

Hydroxychloroquine tablets are approved in the EU and US for treating rheumatoid arthritis and lupus. In the EU, Sanofi’s Plaquenil and generics are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, FDA approval is based on extensive clinical data and biosimilarity assessments. Both regions require detailed dossiers for initial approval and ongoing pharmacovigilance. For expert assistance with regulatory dossiers, compliance, and registration, visit PharmaTradz. We support efficient market access for hydroxychloroquine tablets, ensuring adherence to European and American standards for safe, effective treatment of autoimmune diseases.