Itraconazole Capsules 100mg

Itraconazole Capsules 100mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Itraconazole Capsules 100mg (Preventfung)
B) Itraconazole Capsules 200mg (Preventfung)
C) Itraconazole Capsules 400mg (Preventfung)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Itraconazole Capsules 100mg
Each hard gelatin Capsule contains:
Itraconazole USP……………100mg
(As Pallets)
Excipients……………………….q.s.
Approved colours used in capsule shells.

B) Itraconazole Capsules 200mg
Each hard gelatin Capsule contains:
Itraconazole USP……………….200mg
(As Pallets)
Excipients…………………………….q.s.
Approved colours used in capsule shells.

C) Itraconazole Capsules 400mg
Each hard gelatin Capsule contains:
Itraconazole USP………………….400mg
(As Pallets)
Excipients………………………………q.s.
Approved colours used in capsule shells.

THERAPEUTIC INDICATIONS:

Itraconazole is an antifungal medication used to treat a number of fungal infections. This includes aspergillosis, blastomycosis, coccidioidomycosis, histoplasmosis, and paracoccidioidomycosis. It may be given by mouth or intravenously.

CAUTION & SCHEDULE:

CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
FOR OPTIMAL ABSORPTION, ITRACONAZOLE CAPSULES SHOULD BE TAKEN IMMEDIATELY AFTER A FULL MEAL.

SCHEDULE: SCHEDULE H: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER.

Terfenadine or Astemizole should not be taken simultaneously when the patient is on this medication.

STORAGE & DOSAGE:

Storage: Store below 30 °C.
Protect from Light and moisture.
Dosage: As directed by the Physician

Introduction to Itraconazole Capsules 100mg

Itraconazole Capsules 100mg are a widely prescribed antifungal medication used to treat systemic and superficial fungal infections, including aspergillosis (lung infections), blastomycosis (Gilchrist’s disease), and histoplasmosis (Darling’s disease). Part of the azole class of antifungals, itraconazole works by blocking the synthesis of ergosterol, an essential component of the fungal cell membrane, leading to fungal cell death.

Taj Pharma, recognized as a trusted Itraconazole Capsules 100mg manufacturer in India, ensures premium quality, purity, and efficacy for patients worldwide.

Global Demand

Fungal infections are increasingly prevalent due to rising immunocompromised populations, including HIV/AIDS patients, cancer patients, and transplant recipients. As such, the global demand for itraconazole capsules is expanding rapidly, particularly in North America, Europe, the Middle East, Africa, and the Asia-Pacific regions. Taj Pharma’s production capacity and export expertise make it a reliable global supplier.

Therapeutic Uses of Itraconazole Capsules 100mg

• Aspergillosis: Treats infections in the lungs caused by Aspergillus species.

• Blastomycosis: Manages skin, lung, and systemic infections caused by Blastomyces dermatitidis.

• Histoplasmosis: Controls fungal infections in the lungs and disseminated disease.

• Other infections: Effective for oral, vaginal, fingernail, and toenail fungal infections.

Mechanism of Action

Itraconazole inhibits the enzyme lanosterol 14α-demethylase, which is necessary for ergosterol synthesis in fungal cell membranes. This disruption compromises the fungal cell membrane, resulting in cell death and infection control.

Precautions and Safety

Itraconazole is generally not recommended during pregnancy, unless benefits outweigh potential risks. Patients should consult their healthcare provider if they have liver or heart disease, are pregnant, breastfeeding, or on other medications.

Common Side Effects:

• Nausea and vomiting

• Diarrhea

• Headache

• Abdominal discomfort

• Rare but severe: liver toxicity, allergic reactions, heart failure

Taj Pharma ensures that every batch of Itraconazole Capsules 100mg undergoes rigorous quality checks before dispatch.

Dosage and Administration

• Follow the physician’s prescription strictly.

• Capsules should be swallowed whole, preferably with food to enhance absorption.

• Complete the full prescribed course to prevent recurrence or drug resistance.

• Take doses at even intervals to maintain therapeutic levels.

Taj Pharma includes patient information leaflets with each batch for safe and effective use.

In-Depth Details for Importers, Exporters, and Buyers

Regulatory Documentation Provided

Taj Pharma ensures smooth import/export processes by providing:

• WHO-GMP Certification

• Certificate of Pharmaceutical Product (COPP)

• Free Sale Certificate

• Certificate of Analysis (COA)

• Batch Manufacturing Records (BMR)

• Drug Master File (DMF)

• CTD Dossier for regulated markets

This documentation ensures compliance with international pharmaceutical regulations.

Custom Packaging & Labeling

• Blister Packs: Alu-Alu, PVC/Alu

• Bottles: HDPE/PET

• Private Labeling: Available in multiple languages including English, Arabic, French, Spanish

• Tamper-Evident Packaging: Includes batch number, expiry date, and storage instructions

Custom packaging supports market-specific branding and regulatory compliance.

Shelf-Life, Storage & Dosage Form

• Shelf Life: 24–36 months from manufacturing

• Storage Conditions: Below 30°C, away from light and moisture

• Dosage Form: Hard gelatin capsule, 100mg

• Capsule Appearance: Red/white, elongated

Taj Pharma ensures strict environmental control during storage to preserve efficacy.

Export Certifications

• WHO-GMP Certification

• EU-GMP Compliance

• ISO 9001:2015 Certification

• COPP for global markets

• CTD Dossier for streamlined registration

These certifications make Taj Pharma a reliable partner for international importers.

Target Countries & Export Markets

Taj Pharma exports Itraconazole Capsules 100mg to over 60 countries, including:

Asia-Pacific: Philippines, Thailand, Malaysia, Vietnam, Sri Lanka
Middle East: UAE, Saudi Arabia, Oman, Iraq, Jordan
Africa: Nigeria, Kenya, Ghana, Tanzania, South Africa
Europe & CIS: Ukraine, Belarus, Georgia, Moldova, Armenia
Latin America: Peru, Chile, Ecuador, Dominican Republic

Why is the Most Trusted Manufacturer, Supplier, and Exporter

1. State-of-the-Art Manufacturing

• Fully automated production lines

• Advanced R&D and quality control labs

• Stability testing and microbiology labs

• WHO-GMP-compliant infrastructure

2. Affordable Pricing & Quality Assurance

• Competitive pricing for bulk orders

• Each batch undergoes stringent IP/BP/USP testing

3. Global Presence & Supply Chain Support

• Strong export network across 60+ countries

• Assistance with regulatory registration

• Efficient logistics for timely delivery

4. Top 20 Export Countries

UAE || Saudi || Arabia || Oman || Qatar || Kuwait || Nigeria || Kenya || Ghana || South Africa || Egypt || Germany || France || UK || Italy || Spain || Sri Lanka || Myanmar Malaysia || Philippines || Vietnam

Technical Product Specification Table 

Contact Taj Pharma for Bulk Supply

Looking for a trusted Itraconazole Capsules 100mg manufacturer in India?

Taj Pharma provides:

• Bulk export and private-label solutions

• Regulatory and dossier support

• Flexible minimum order quantities (MOQs)

• Timely global delivery

📞 Contact Details:
Website: www.tajpharma.in
Email: info@tajpharma.com
Location: Vapi, Gujarat, India

Top 10 FAQs 

1. What is Itraconazole used for?
Treats serious fungal infections like aspergillosis, blastomycosis, and histoplasmosis.

2. How does itraconazole work?
Inhibits fungal cell membrane synthesis, preventing growth and killing fungi.

3. Is it safe in pregnancy?
Avoid unless benefits outweigh potential risks.

4. Who is a leading manufacturer in India?
Taj Pharma Ltd, Vapi, Gujarat.

5. Side effects of itraconazole?
Nausea, vomiting, diarrhea, headache, and rare liver toxicity.

6. Can it be taken with food?
Yes, improves absorption.

7. Shelf life?
24–36 months.

8. Storage conditions?
Below 30°C, away from sunlight and moisture.

9. Packaging options?
Blister packs, bottles, private-label options.

10. Regulatory support for importers?
WHO-GMP, COPP, COA, CTD dossier.