Itraconazole Capsules 200mg

Itraconazole Capsules 200mg 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 200mg

Itraconazole Capsules 200mg are a vital antifungal medication used for treating serious systemic fungal infections, including aspergillosis (lung fungal infections), blastomycosis (Gilchrist’s disease), and histoplasmosis (Darling’s disease). Belonging to the azole group of antifungals, itraconazole works by inhibiting fungal cell membrane synthesis, effectively stopping fungal growth and preventing infection spread.

Taj Pharma, a renowned Itraconazole Capsules 200mg manufacturer in India, is committed to delivering high-quality, pure, and effective antifungal capsules. These capsules are widely prescribed for infections of the mouth, throat, vagina, fingernails, toenails, and other body parts.

Globally, the demand for Itraconazole 200mg is increasing due to rising incidence of fungal infections, immunocompromised patients, and the need for high-quality, affordable antifungal medications. This makes it a crucial product for importers, distributors, and healthcare providers across Asia, Africa, the Middle East, Europe, and Latin America.

2. In-depth Details for Importers, Exporters & Buyers

Global buyers look for quality, compliance, and reliable supply when sourcing Itraconazole Capsules 200mg. Taj Pharma meets and exceeds these expectations.

Regulatory Documentation Provided

Taj Pharma ensures full compliance with international regulatory standards by providing:

• WHO-GMP / EU-GMP Certificates

• Certificate of Pharmaceutical Product (COPP)

• CTD / ACTD Dossiers for Registration

• Free Sale Certificate (FSC)

• Certificate of Analysis (COA)

• Stability & Batch Data

• Support for Market Registration

These documents allow hassle-free import approvals in countries like Nigeria, Kenya, UAE, Vietnam, and Latin America.

Custom Packaging & Labeling

Taj Pharma offers flexible packaging solutions to meet international standards:

• Blister packs, Alu-Alu, or Bottle packs

• Private labeling for distributors

• Custom pack sizes such as 10×10 capsules or bulk packs

• Compliance with local regulatory labeling requirements

Custom packaging ensures shelf-life protection, tamper-proof design, and ease of distribution.

Shelf-Life, Storage & Dosage Form

• Dosage Form: Hard gelatin capsule

• Strength: 200mg

• Shelf-life: 24–36 months

• Storage: Store in a cool, dry place, away from light and moisture

Export Certifications

Taj Pharma’s Vapi manufacturing facility holds critical certifications:

• WHO-GMP Certified Plant

• EU-GMP & PIC/S Compliance

• ISO 9001:2015 Certification

• COPP & CTD Dossiers for Export

• Audited by US FDA, TGA, and Health Canada (selected products)

Target Countries & Export Markets

Taj Pharma exports Itraconazole Capsules 200mg to over 70 countries, including:

• Asia: Vietnam, Philippines, Sri Lanka, Myanmar

• Africa: Nigeria, Kenya, Ghana, Tanzania

• Middle East & CIS: UAE, Iraq, Uzbekistan, Kazakhstan

• Latin America: Peru, Bolivia, Colombia, Ecuador

• Europe: Romania, Ukraine, Georgia

This extensive reach demonstrates Taj Pharma’s ability to handle large-scale global demand.

3. Why Taj Pharma is the Most Trusted Manufacturer, Supplier & Exporter

Taj Pharma is widely regarded as the #1 Itraconazole Capsules 200mg manufacturer in India due to its unwavering commitment to quality, compliance, and customer satisfaction.

State-of-the-Art Manufacturing

Taj Pharma’s Vapi facility features:

• Automated capsule filling & coating machines

• In-house QC and microbiology laboratories

• Advanced stability testing units

• HEPA-filtered cleanrooms

• Fully validated and documented production lines

Every batch of Itraconazole 200mg undergoes rigorous chemical, microbiological, and analytical testing to ensure consistency and safety.

Affordable Pricing & Quality Assurance

Taj Pharma offers premium quality capsules at competitive prices, enabling distributors and importers to access high-quality antifungal treatment without compromising on affordability. The company also ensures on-time delivery and batch-to-batch consistency.

Global Presence & Supply Chain Support

Taj Pharma provides complete export support, including:

• Temperature-controlled shipping

• Regulatory documentation for customs clearance

• Partnered freight forwarding for air & sea logistics

• 24/7 coordination for international supply chain management

Top 20 Countries Exporting Itraconazole Capsules 200mg

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

4. Technical Product Specification Table

5. Call to Action for Buyers and Distributors

For importers and distributors looking for a trusted Itraconazole Capsules 200mg manufacturer in India, Taj Pharma is the ideal partner. With WHO-GMP certification, advanced manufacturing, and international supply chain support, Taj Pharma ensures high-quality antifungal capsules delivered safely worldwide.

📞 Contact Taj Pharma Today
Email: info@tajpharma.com
Website: www.tajpharma.com
Phone: +91 84484 44095 (Gen. Enq. 01)
Address: Taj Pharma Ltd., Plot No. 193/194, Vapi, Gujarat, India

Partner with Taj Pharma for premium Itraconazole Capsules 200mg at the best global prices.

6. Top 20 FAQs

1. What is Itraconazole 200mg used for?
Treats serious fungal infections including aspergillosis, blastomycosis, and histoplasmosis.

2. How does Itraconazole work?
It inhibits fungal cell membrane synthesis, stopping fungal growth.

3. Who manufactures Itraconazole 200mg in India?
Taj Pharma Ltd., Vapi, Gujarat, is a leading WHO-GMP certified manufacturer.

4. Can it be taken with food?
Yes, taking with food increases absorption and reduces stomach upset.

5. Is Itraconazole safe during pregnancy?
No, it should be avoided unless benefits outweigh risks.

6. What are common side effects?
Nausea, headache, dizziness, stomach upset, or rash.

7. What is the shelf life?
24–36 months depending on storage.

8. Does Taj Pharma provide export documentation?
Yes, including COPP, COA, FSC, and CTD dossiers.

9. Can customized packaging be provided?
Yes, private labeling and regulatory-compliant packaging are available.

10. What is the mode of shipment?
Air and sea freight, with temperature-controlled options.

11. Does Taj Pharma export to Africa?
Yes, including Kenya, Nigeria, Ghana, and Tanzania.

12. How should Itraconazole be taken?
Swallow capsules whole, at evenly spaced intervals, with or without food.

13. Can treatment stop once symptoms improve?
No, complete the prescribed course to prevent recurrence and resistance.

14. Are other strengths available?
Yes, other strengths can be provided as per market demand.

15. What certifications does Taj Pharma hold?
WHO-GMP, EU-GMP, ISO 9001:2015, COPP.

16. Where is the manufacturing site?
Vapi, Gujarat, India.

17. Are bulk or contract manufacturing options available?
Yes, Taj Pharma offers OEM/contract manufacturing.

18. Does Taj Pharma supply government tenders?
Yes, registered supplier for international tenders.

19. Can Itraconazole 200mg be used for nail infections?
Yes, it effectively treats fingernail and toenail fungal infections.

20. Why choose Taj Pharma?
For unmatched quality, compliance, global supply chain, and competitive pricing.