Quinine Sulfate Tablets Generics - Manufacturers & Suppliers
Qualaquin(US)
| Product/Composition:- | Quinine Sulfate Tablets |
|---|---|
| Strength:- | 300 mg, 324 mg, 325 mg, 648 mg |
| Form:- | Tablet |
| Reference Brands:- | Qualaquin(US) |
| MOQ | As per the manufacturer batch size |
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Quinine sulfate inhibits the parasite's heme polymerase, preventing detoxification of toxic heme produced during hemoglobin digestion. This leads to parasite death. Benefits include effective treatment of uncomplicated malaria, rapid symptom relief, and high efficacy against resistant strains, making it a vital option when other antimalarials fail or are unavailable.
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.