Sulfasalazine Tablets/Capsule

Form: Tablet/Capsules

Strength: 500 mg, 1000 mg

Reference Brands: Azulfidine(US); Salazopyrin(EU)

Category: Antibiotics

Sulfasalazine tablets are approved in both the EU and US for treating rheumatoid arthritis and inflammatory bowel disease. In the EU, brands like Salazopyrin are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, FDA approval relies on extensive clinical data; generic formulations are available. Both regions require detailed dossiers, including clinical trial results, quality assurance, and pharmacovigilance plans, for approval and ongoing safety monitoring. For expert regulatory support, dossier management, and registration services, visit PharmaTradz. We ensure seamless market access for sulfasalazine tablets, adhering to European and US standards for safe, effective disease management.