Griseofulvin suspension
Form: Suspension
Strength: 50 mg/5 mL; 125mg/5ml
Reference Brands: Grifulvin V(US); Griséofulvine(EU)
Category: Anti-fungal
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.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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