Sucralfate tablet

Form: Tablets

Strength: 1 g

Reference Brands: Carafate(US)

Category: Gastrointestinal Drugs

Sucralfate tablets, marketed as Carafate, are approved in the US by the FDA and in the EU via EMA for the treatment of gastric and duodenal ulcers. Regulatory approval requires a detailed dossier including clinical efficacy, safety profiles, manufacturing standards, and pharmacovigilance plans. The FDA reviews clinical trial and quality data for approved use, while the EMA ensures compliance with regional safety and manufacturing standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence to regional requirements supports timely approval, safe use, and global availability of sucralfate tablets, aiding ulcer healing and gastrointestinal protection worldwide.