Product/Composition:- | Racecadotril Capsule |
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Strength:- | 100 mg |
Form:- | Capsules |
Reference Brands:- | Hidrasec(US & EU) |
MOQ | As per the manufacturer batch size |
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Racecadotril capsules are enkephalinase inhibitors that reduce intestinal secretion by blocking enkephalin breakdown. They effectively treat diarrhea, decrease stool volume, and relieve symptoms quickly. Benefits include fewer side effects, supporting hydration, and promoting faster recovery in acute diarrhea, especially in children and adults.
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.