Product/Composition:- | Fluconozole Powder |
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Strength:- | 350 mg, 1400mg(to be reconstituted) |
Form:- | Powder for Oral Suspension |
Reference Brands:- | Diflucan(EU & US) and Generics |
MOQ | As per the manufacturer batch size |
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Fluconazole powder for suspension inhibits fungal cell membrane synthesis by blocking lanosterol 14α-demethylase. It treats systemic and yeast infections, offering benefits like convenient pediatric dosing, excellent tissue penetration, broad-spectrum activity, and a favorable safety profile. It’s essential for managing severe fungal infections in children and adults.
Fluconazole powder for suspension is approved in the EU and US for pediatric and oral use. In the EU, Pfizer’s Diflucan powder is regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, the FDA has approved Diflucan powder based on comprehensive clinical data and biosimilarity assessments, with ongoing pharmacovigilance. Both regions require detailed dossiers for approval, ensuring product quality and safety. For expert assistance with pharmaceutical dossiers, regulatory filings, and compliance, visit Pharmatradz, your trusted partner in regulatory solutions, helping expedite market access and ensuring adherence to regulatory standards.