Itraconazole Sustained Release Tablets 400mg

Itraconazole Sustained Release Tablets 400mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Itraconazole Sustained Release Tablets 400mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Itraconazole Sustained Release Tablets 400mg
Each film coated Sustained Release Tablet contains:
Itraconazole USP…………….100mg
Excipients………………………..q.s.
Colours: Titanium Dioxide IP

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 TABLETS 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 Sustained Release Tablets 400mg

Itraconazole Sustained Release Tablets 400mg are a specialized antifungal medication widely used to treat fungal infections in various parts of the body, including the mouth, throat, vagina, fingernails, and toenails. These tablets work by destroying the fungal cell membrane, effectively stopping fungal growth and alleviating symptoms of infection.

Itraconazole is a member of the azole antifungal group, and its sustained-release formulation ensures longer-lasting therapeutic effects, reducing the frequency of doses and improving patient adherence.

Globally, Itraconazole SR Tablets are in high demand due to the rising incidence of fungal infections, particularly among immunocompromised patients, diabetics, and individuals with chronic diseases.

Taj Pharma, a leading Itraconazole Sustained Release Tablets 400mg manufacturer in India, ensures high-quality, reliable, and WHO-GMP certified antifungal tablets suitable for international markets.

Uses and Benefits

Therapeutic Indications

• Oral Thrush: Treats fungal infections in the mouth and throat.

• Vaginal Candidiasis: Effective for yeast infections in women.

• Onychomycosis: Treats fungal nail infections in fingernails and toenails.

• Systemic Fungal Infections: Addresses more severe fungal conditions affecting internal organs.

• Other Skin and Mucosal Fungal Infections: Reduces itching, redness, and inflammation.

Dosage and Administration

• Take exactly as prescribed by your doctor.

• Swallow the tablet whole; do not crush or chew.

• Can be taken with food to enhance absorption.

• Maintain evenly spaced dosing to ensure therapeutic effectiveness.

• Complete the full course even if symptoms disappear early, to prevent recurrence or resistance.

Side Effects

Common side effects may include:

• Nausea, vomiting, diarrhea

• Dizziness, headache

• Abdominal pain, constipation, dyspepsia

• Allergic reactions (rare but serious)

Seek emergency medical care if signs of a severe allergic reaction occur, including swelling of the face, lips, tongue, or throat, severe rash, or difficulty breathing.

In-Depth Details for Importers, Exporters, and Buyers

Regulatory Documentation Provided

Taj Pharma ensures all international regulatory requirements are met:

• WHO-GMP Certification

• EU-GMP Compliance

• Certificate of Pharmaceutical Product (COPP)

• CTD/ACTD Dossier

• Certificate of Analysis (COA)

Custom Packaging & Labeling

• Alu-Alu blister packs for tablet protection

• Bulk packaging for hospitals and distributors

• Customizable labeling for various global markets

Shelf-Life, Storage, and Dosage Form

• Shelf-life: 24–36 months

• Storage: Keep below 30°C, away from sunlight and moisture

• Dosage Form: Sustained-release film-coated tablets

Export Certifications

• WHO-GMP

• EU-GMP

• ISO 9001:2015 & ISO 14001:2015

• COPP & Free Sale Certificate

Target Countries & Export Markets

Taj Pharma exports Itraconazole SR Tablets 400mg to over 80 countries, including:

• Asia: Bangladesh, Sri Lanka, Vietnam, Philippines

• Africa: Nigeria, Kenya, South Africa, Ghana

• Middle East: UAE, Saudi Arabia, Iraq

• Europe & CIS: Ukraine, Belarus, Russia

• Latin America: Peru, Ecuador, Bolivia

Why Taj Pharma is the Most Trusted Manufacturer/Supplier/Exporter

1. State-of-the-Art Manufacturing Facilities

• Located in Vapi, Gujarat, with advanced tablet compression, coating, and packaging machines

• Modern quality control laboratories for accurate testing

• WHO-GMP certified cleanrooms and contamination-free production environment

2. Quality Assurance & Control

• Compliance with IP, BP, USP, EP standards

• Internal and external audits for consistent quality

• Ensures high-purity, safe, and effective antifungal tablets

3. Affordable Pricing & Cost Efficiency

• Vertical integration reduces production costs, offering competitive pricing for global buyers

• Flexible bulk orders and PCD franchise pricing

• Long-term contracts ensure price stability

4. Global Supply Chain & Distribution

• Efficient logistics for timely delivery worldwide

• Complete documentation support for smooth customs clearance

• Dedicated export team for regulatory compliance and shipment tracking

5. Ethical Practices & Partnerships

• Transparent long-term collaborations

• Ethical manufacturing and marketing standards

• Commitment to quality, safety, and client satisfaction

Top 20 Countries Where Taj Pharma Exports Itraconazole Sustained Release Tablets 400mg

Nigeria, Kenya, Ghana, South Africa, Tanzania, Uganda, Philippines, Vietnam, Myanmar, Sri Lanka, Nepal, UAE, Saudi Arabia, Iraq, Yemen, Kazakhstan, Uzbekistan, Peru, Bolivia, Chile

Technical Product Specification Table

PCD Pharma Franchise & Contract Manufacturing Opportunities

Taj Pharma provides PCD Pharma Franchise and third-party manufacturing for Itraconazole Sustained Release Tablets 400mg PAN India.

Benefits include:

• WHO-GMP certified formulations

• Monopoly marketing rights

• Promotional support

• Competitive distributor pricing

Cities Covered: Mumbai, Delhi, Hyderabad, Chennai, Ahmedabad, Kolkata, Lucknow, and more.

Call to Action

Global importers, distributors, and PCD franchise partners seeking a reliable Itraconazole Sustained Release Tablets 400mg manufacturer and supplier in India can contact Taj Pharma today.

📞 Contact: Taj Pharma India Ltd.
📍 Vapi, Gujarat, India
🌐 www.tajpharma.com
📧 info@tajpharma.com 

Top 20 FAQs 

1. What is Itraconazole Sustained Release Tablets 400mg used for?
   Treats fungal infections in mouth, throat, vagina, nails, and skin.

2. Who manufactures it in India?
   Taj Pharma Ltd, Vapi, Gujarat.

3. Can it be taken with food?
   Yes, enhances absorption.

4. Common side effects?
   Nausea, dizziness, headache, vomiting, diarrhea.

5. Allergic reactions possible?
   Rare, but seek immediate medical help for swelling, rash, or difficulty breathing.

6. Dosage form?
   Sustained-release film-coated tablet.

7. Shelf life?
   24–36 months.

8. Storage conditions?
   Cool, dry place below 30°C.

9. WHO-GMP certified?
   Yes.

10. Export countries?
    Over 80 countries worldwide.

11. Regulatory documents provided?
    WHO-GMP, COPP, CTD dossier, COA.

12. Third-party manufacturing available?
    Yes.

13. Safe for immunocompromised patients?
    Yes, under doctor supervision.

14. Benefits of sustained-release tablets?
    Longer effect, reduced dosing frequency, better adherence.

15. How long to complete the course?
    As prescribed by the doctor; do not stop early.

16. Pharmacopoeial standards?
    IP, BP, USP, EP.

17. PCD Pharma franchise available?
    Yes.

18. Packaging options?
    Alu-Alu blister packs, bulk packs.

19. Can it treat nail fungal infections?
    Yes, including fingernails and toenails.

20. How to contact for exports?
    Email: info@tajpharma.com