Product/Composition:- | Griseofulvin suspension |
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Strength:- | 50 mg/5 mL; 125mg/5ml |
Form:- | Suspension |
Reference Brands:- | Grifulvin V(US); Griséofulvine(EU) |
MOQ | As per the manufacturer batch size |
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Griseofulvin disrupts fungal cell mitosis by inhibiting microtubule formation, preventing fungal growth and replication. It effectively treats dermatophyte infections of skin, hair, and nails. Benefits include targeted oral therapy, good tissue penetration, and high efficacy against superficial fungi, making it a dependable choice for dermatophyte management.
Griseofulvin suspension is approved in the EU and US for treating dermatophyte infections in children and adults. In the EU, various generic formulations are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing quality. In the US, FDA approval for generic versions is based on comprehensive data and biosimilarity assessments. Both regions require detailed dossiers for initial approval and ongoing pharmacovigilance. For expert assistance with pharmaceutical dossiers, regulatory submissions, and compliance, visit PharmaTradz. We facilitate smooth market access for griseofulvin suspension, ensuring adherence to European and American standards for safe, effective dermatophyte treatment.