Oral Rehydration Salts (ORS) Powder

Form: Powder for Oral Solution

Strength: 13.5 g or 22 g packets

Reference Brands: Pedialyte, Gatorade(US); Rehidrat(EU)

Category: Medical Aid

Oral Rehydration Salts (ORS) powder is approved in the EU and US for treating dehydration caused by diarrhea. In the EU, brands like Rehidrat are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing quality. In the US, approval depends on comprehensive clinical data; generic ORS products are widely 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 preparation, and compliance, visit PharmaTradz. We ensure seamless market access for ORS formulations, adhering to European and US standards for safe, effective rehydration therapy in vulnerable populations.