Description

Griseofulvin Tablets (125mg / 250mg / 500mg)

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 Griseofulvin Tablets in India. Griseofulvin is a classic, orally active Antifungal Agent derived from the mold Penicillium griseofulvum. It is primarily indicated for the treatment of dermatophyte infections of the skin, scalp, hair, and nails (Tinea infections) where topical therapy has failed or is inappropriate.

We offer Contract Manufacturing (Third Party) services for this long-standing antifungal. Griseofulvin is practically insoluble in water, which historically limited its effectiveness. Our WHO-GMP certified facility in Mumbai utilizes advanced Micronization Technology (reducing particle size to <4 microns) to dramatically improve absorption and bioavailability. Healthy Inc manages the export logistics, supplying dermatology clinics and pharmacy chains across Africa, the Middle East, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Particle size dictates potency.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Micronization: Regular Griseofulvin is poorly absorbed. We exclusively manufacture “Ultramicronized” or “Micronized” formulations. By pulverizing the drug particles to microscopic size, we increase the surface area, allowing the drug to dissolve and enter the bloodstream efficiently.

  • Dissolution Enhancement: We use surfactants (wetting agents) in the granulation process to help the hydrophobic drug mix with stomach fluids.

  • Stability: The product is robust and stable, with a shelf life of up to 3 years even in tropical climates (Zone IVb).

• The Exporter: Healthy Inc

  • Bulk Supply: We act as a key supplier for government health departments treating tinea capitis (scalp ringworm) outbreaks in schools, offering cost-effective bulk jars (500s or 1000s).

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 90-115% of the label claim (specific limits for this antibiotic).

• Particle Size Analysis: We strictly validate the particle size distribution (D90 value) of the raw material before processing.

5. Why Use Griseofulvin?

It binds to the keratin to protect new skin.

• Mechanism: Griseofulvin is fungistatic. It enters the fungal cell and binds to tubulin, disrupting the mitotic spindle. This stops the fungus from dividing (mitosis). Uniquely, it deposits in keratin precursor cells (skin, hair, nails). As these cells grow out, they become resistant to fungal invasion, effectively “pushing out” the infection.

• Key Indications:

  • Tinea Capitis: Ringworm of the scalp (common in children).

  • Onychomycosis: Fungal infection of the fingernails or toenails.

  • Tinea Corporis/Cruris/Pedis: Severe ringworm of the body, groin, or feet (Athlete’s Foot) unresponsive to creams.

• Advantage: It remains the Gold Standard for Tinea Capitis in children due to its safety profile and efficacy against Microsporum species.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers 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 Griseofulvin Tablets?

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

• Q: Is it Gris-PEG?

  A: Gris-PEG is a brand name (Valeant). We manufacture the Generic Equivalent (Griseofulvin), which works exactly the same way.

• Q: Must I take it with fat?

  A: YES. Absorption is drastically improved if taken with a high-fat meal (e.g., whole milk, cheese, peanut butter). Taking it on an empty stomach may make it ineffective.

   

• Q: How long does treatment last?

  A: It is slow-acting. Skin infections take 2-4 weeks; scalp takes 4-6 weeks; nails can take 6 months to a year to fully clear.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Adults: 500mg daily (single or divided doses).

• Children: 10mg/kg daily.

• Administration: Take immediately after a fatty meal to maximize absorption.

9. Side Effects and Precautions

• Photosensitivity: Can cause severe sunburn. Avoid direct sunlight.

• CNS: Headache (very common initially), dizziness, or fatigue.

• Interaction: Reduces the effectiveness of Oral Contraceptives (Birth Control Pills) and Warfarin.

• Pregnancy: Category X. Contraindicated. Can cause birth defects.

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep container tightly closed.