Racecadotril Capsule

Form: Capsules

Strength: 100 mg

Reference Brands: Hidrasec(US & EU)

Category: Gastrointestinal Drugs

Racecadotril capsules, marketed as Hidrasec, are approved in select regions of the EU and in the US for diarrhea treatment. Regulatory approval requires a detailed dossier 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 standards. For dossier preparation, regulatory pathways, and market access strategies, visit PharmaTradz. Proper adherence to regional regulations supports swift approval, safe use, and global availability, helping manage acute diarrhea in pediatric and adult patients worldwide effectively.