High-Dose Antifungal Therapy

Fluconazole Brand Tablets 400mg

WHO-GMP certified fluconazole 400mg tablets for high-dose antifungal therapy and critical infections with comprehensive global export capabilities.

24-36 months Shelf Life

10×10 blister packs Packaging

WHO-GMP Compliance

High-Dose Therapy WHO-GMP Export Ready

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Key Highlights

Maximum potency for life-threatening fungal infections
Optimized for systemic and invasive candidiasis
Complete regulatory bundle: COA, MOA, BMR, Stability, PIL

Technical Specifications

Fluconazole 400mg Tablets Details

Product Information

Strength	400mg
Dosage Form	Tablets
Route	Oral
Indications	Critical infections, high-dose therapy, invasive candidiasis
HS Code	3004.20.90

Quality & Storage

Regulatory Support	WHO-GMP, ISO 9001, CTD/eCTD dossier
Shelf Life	24-36 months
Storage	Room temperature
Packaging Options	10×10 blister packs, 30s, 100s, hospital packs
Target Markets	Critical care units, tertiary hospitals, specialty centers

Clinical Applications

Therapeutic Uses for Fluconazole 400mg

Critical Infections

Maximum potency formulation for life-threatening systemic fungal infections requiring aggressive therapeutic intervention.

Invasive Candidiasis

High-dose therapy for invasive candidiasis and other severe fungal infections in immunocompromised patients.

High-Dose Therapy

Optimized for patients requiring maximum drug exposure for effective treatment of complex fungal infections.

Regulatory Support

Complete Documentation Package

WHO-GMP Certificate

Valid WHO-GMP certification for international market access

Certificate of Analysis

Detailed COA with complete quality parameters

Stability Data

ICH-compliant stability studies for all climate zones

CTD/eCTD Dossier

Complete registration dossier for global submissions

Global Export

Worldwide Market Presence

Target Export Markets

Asia: Vietnam, Philippines, Thailand, Malaysia, Sri Lanka
Africa: Nigeria, Kenya, South Africa, Ghana, Cameroon
Latin America: Peru, Colombia, Brazil, Mexico
Middle East: UAE, Saudi Arabia, Qatar
CIS: Kazakhstan, Uzbekistan

Export Services

Multilingual labeling and packaging
Country-specific regulatory support
Efficient logistics and supply chain
Documentation translation services
Technical support and training

Ready to Import Fluconazole 400mg Tablets?

Contact our export team for competitive pricing, regulatory support, and seamless global supply chain solutions.

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