Bisacodyl tablets

Form: Tablets

Strength: 5 mg

Reference Brands: Dulcolax:(US & EU)

Category: Gastrointestinal Drugs

Bisacodyl 5 mg tablets, marketed as Dulcolax, are approved in the US by the FDA and in the EU via EMA for short-term constipation relief. Regulatory approval requires detailed dossiers including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews clinical trial and quality data for timely approval, while the EMA ensures compliance with regional safety and manufacturing regulations. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence to regional requirements supports timely approval, safe use, and worldwide availability of bisacodyl tablets, helping patients manage constipation effectively across regions.