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Pediatric & Prophylactic Applications

Fluconazole Tablets 50mg

WHO-GMP certified fluconazole 50mg tablets optimized for pediatric patients, prophylactic treatment, and mild fungal infections. Complete regulatory documentation and global export support.

24-36 months Shelf Life
10×10 blister packs Packaging
WHO-GMP Compliance
Brand Quality WHO-GMP Export Ready Pediatric Safe
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Fluconazole 50mg Tablets

Key Highlights

  • Optimized for pediatric dosing with accurate 50mg strength
  • Excellent for prophylactic treatment in immunocompromised patients
  • Complete regulatory bundle: COA, MOA, BMR, Stability, PIL
  • Validated dissolution profile for optimal bioavailability
Technical Specifications

Fluconazole 50mg Tablets Details

Product Information

Strength 50mg
Dosage Form Tablets
Route Oral
Indications Pediatric candidiasis, prophylactic treatment, mild fungal infections, oropharyngeal candidiasis
HS Code 3004.20.90

Quality & Storage

Regulatory Support WHO-GMP, ISO 9001, CTD/eCTD dossier, FDA/EMA guidance
Shelf Life 24-36 months
Storage Room temperature (15-30°C), protect from moisture
Packaging Options 10×10 blister packs, 30s, 100s, hospital packs, pediatric formulations
Target Markets Pediatric hospitals, prophylactic programs, general healthcare, developing markets
Clinical Applications

Therapeutic Uses for Fluconazole 50mg

Pediatric Applications

Optimized dosing for pediatric patients with mild to moderate fungal infections. Suitable for children with weight-based dosing requirements.

Prophylactic Treatment

Prevention of fungal infections in immunocompromised patients and those undergoing immunosuppressive therapy.

Mild Infections

Treatment of mild fungal infections where lower dosing is appropriate for patient safety and therapeutic efficacy.

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 50mg Tablets?

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

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