Description

Fluconazole Tablets (50mg / 100mg / 150mg / 200mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)

Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a specialized Manufacturer of Fluconazole Tablets in India. Fluconazole is a premier Triazole Antifungal Agent used globally for the treatment of superficial and systemic fungal infections. It is most famous as the “Single-Dose Cure” (150mg) for Vaginal Candidiasis (Yeast Infection), but it is also a critical life-saving drug for Cryptococcal Meningitis in HIV patients.

We offer Contract Manufacturing (Third Party) services for this high-demand antifungal. Fluconazole requires precise formulation to ensure rapid dissolution, which is key to its high bioavailability. Our WHO-GMP certified facility in Mumbai utilizes advanced Direct Compression or Wet Granulation technologies depending on the strength, ensuring robust tablets that withstand global shipping. Healthy Inc manages the export logistics, supplying pharmacy chains, women’s health clinics, and government tenders across Africa, the USA, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Optimizing the single-dose cure.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Single-Dose Packaging: The 150mg strength is often sold as a “Kit” (1 tablet per pack). We have specialized blistering lines dedicated to Mono-Carton Packaging, creating premium-looking single-dose packs that are shelf-ready for retail pharmacies.

  • Solubility Enhancement: While Fluconazole is moderately soluble, we use specific disintegrants to ensure the tablet breaks down in < 10 minutes, allowing for rapid absorption and quick symptom relief.

  • Taste Masking: For film-coated variants, we use a smooth polymer coat to mask the drug’s inherent bitterness, improving compliance for patients on long-term therapy (e.g., for meningitis).

• The Exporter: Healthy Inc

  • Differentiated Packs: We offer 1-tablet blisters for OTC vaginal thrush markets and bulk 100s jars for hospital use (treating systemic infections), maximizing market coverage.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >80% of the drug releases within 30 minutes.

• Assay: We confirm the potency is strictly within 90-110% of the label claim.

• Impurity Profiling: We strictly monitor for degradation products to ensure safety over the 3-year shelf life.

5. Why Use Fluconazole?

It selectively kills the fungus without harming the host.

• Mechanism: Fluconazole works by inhibiting the fungal enzyme Lanosterol 14α-demethylase. This enzyme is responsible for converting lanosterol to Ergosterol, a vital component of the fungal cell membrane. Without ergosterol, the membrane becomes leaky and the fungus dies. Crucially, Fluconazole has a much higher affinity for fungal enzymes than human enzymes, making it safer than older antifungals (like Ketoconazole).

• Key Indications:

  • Vaginal Candidiasis: Effective single-dose treatment.

  • Oropharyngeal Candidiasis: Thrush in the mouth/throat (common in immunocompromised patients).

  • Cryptococcal Meningitis: Maintenance therapy to prevent relapse in AIDS patients.

  • Tinea Infections: Ringworm, Athlete’s Foot (when creams fail).

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers (with Bioequivalence Studies) for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Fluconazole Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Is it Diflucan?

  A: Diflucan is the brand name (Pfizer). We manufacture the Generic Equivalent (Fluconazole), which is bioequivalent.

• Q: How fast does it work for yeast infection?

  A: For the 150mg single dose, symptom relief usually begins within 24 hours, with complete resolution in a few days.

• Q: Is it safe during pregnancy?

  A: Generally Avoided. High doses can cause birth defects. A single low dose (150mg) may be used if benefits outweigh risks, but topical creams are preferred during pregnancy.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Vaginal Candidiasis: 150mg Single Dose (Oral).

• Oral Thrush: 50mg to 100mg once daily for 7-14 days.

• Systemic Infections / Meningitis: 200mg to 400mg daily.

• Administration: Swallow whole. Can be taken with or without food.

9. Side Effects and Precautions

• Gastrointestinal: Nausea, stomach pain, diarrhea, headache.

• Liver: Rare risk of hepatotoxicity. Monitor liver enzymes in long-term users.

• Skin: Rare but serious rashes (Stevens-Johnson Syndrome) can occur, especially in AIDS patients.

• QT Prolongation: Use caution in patients with heart rhythm disorders.

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep container tightly closed.