Quinine Sulfate Tablets

Form: Tablet

Strength: 300 mg, 324 mg, 325 mg, 648 mg

Reference Brands: Qualaquin(US)

Category: Medical Aid

Quinine sulfate tablets are approved in the EU and US for the treatment of uncomplicated malaria. In the US, brands like Qualaquin are regulated by the FDA, supported by dossiers demonstrating safety, efficacy, and quality standards, though use is limited due to side effects. In the EU, approval depends on national regulations, with dossiers including clinical trial data and manufacturing practices. Both regions require detailed dossiers for approval, including pharmacovigilance plans for safety monitoring. Due to decreased use and potential toxicity, strict prescribing and monitoring are enforced. For expert support in regulatory dossier preparation, compliance, and registration, visit PharmaTradz. We ensure seamless market access aligned with European and US standards.