Clofazimine Capsules 100mg

Clofazimine Capsules 100mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Clofazimine Capsules IP 100mg
• Clofazimine Capsules IP 50mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• Clofazimine Capsules IP 100mg
  Each soft gelatin capsule contains:
  Clofazimine I.P………………….100mg
  Excipients……………………………q. s
  Colours: Red Oxide of Iron & Black Oxide of Iron.
• Clofazimine Capsules IP 50mg
  Each soft gelatin capsule contains:
  Clofazimine I.P………………………50mg
  Excipients………………………………q. s
  Colours: Red Oxide of Iron & Black Oxide of Iron.

THERAPEUTIC INDICATIONS:

• Clofazimine is a drug used to treat leprosy. It can slow down the growth and weakly kill Mycobacterium leprae, the bacterium that causes leprosy. It is used in combination with rifampicin and dapsone for the treatment of the many forms of leprosy.

CAUTION & SHEDULE:

• CAUTION:  SWALLOW WHOLE DO NOT CHEW OR CRUSH
• Shedule: It is dangerous to take this preparation except in accordance with the medical advice.
  Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

• Storage: Store at a temperature not exceeding 30°C. Protect from moisture.
  Read enclosed leaflet before use.
  Keep medicine out of reach of children.
• Dosage: As directed by the Physician.

Introduction to Clofazimine Capsules 100mg

Clofazimine Capsules 100mg are a key pharmaceutical product used in the long-term treatment of leprosy (Hansen’s disease) and certain resistant forms of tuberculosis (TB). Clofazimine works by killing bacteria responsible for these chronic infections while reducing inflammation in affected tissues. It is an essential component of WHO-approved MDT (Multi-Drug Therapy) for leprosy.

Global demand for Clofazimine Capsules 100mg continues to rise due to:

• Increased detection and treatment programs for leprosy

• High prevalence of Mycobacterium leprae infections in Asia, Africa, and Latin America

• Expanded research use in drug-resistant TB regimens

• Government-funded public health programs

Taj Pharma, a leading Clofazimine Capsules 100mg manufacturer in India, plays a crucial role in supplying high-purity, therapeutically effective, and globally compliant formulations to international health systems.

 Uses and Medical Importance

Clofazimine is widely used in combination therapy for:

• Leprosy (Hansen’s disease) – standard WHO MDT regimen

• ENL (Erythema Nodosum Leprosum) – reduces inflammatory reactions

• Drug-resistant tuberculosis (off-label in specific regimens)

The medicine must be taken with food for proper absorption. Patients are advised to complete the full course to prevent relapse or resistance. Side effects may include skin discoloration, abdominal discomfort, nausea, and rashes, which usually improve with continued treatment.

As healthcare systems strengthen infectious disease management, international buyers increasingly prefer reliable, WHO-GMP-certified manufacturers like Taj Pharma.

In-depth Details for Importers, Exporters & Global Buyers

Regulatory Documentation Offered by Taj Pharma

Taj Pharma provides a full set of export-ready regulatory documents required for global registration:

• WHO-GMP Certificate

• Certificate of Pharmaceutical Product (COPP)

• Free Sale Certificate (FSC)

• ACTD/CTD Dossier (Module 1–5)

• Stability data (Zone I–IV)

• Batch Manufacturing Records (BMR/BPR)

• COA, MOA, MSDS

• Analytical validation & method validation

• Pack inserts and artworks

• Bioequivalence (where required)

These documents ensure smooth product registration across regulated and semi-regulated markets.

Custom Packaging, Labeling & Export Presentation

Taj Pharma offers fully customizable packaging solutions, supporting all global markets:

• Hard gelatin capsules packed in blisters or bottles

• Alu-Alu or PVC blister packs

• Multilingual packaging for tender supply

• Hospital bulk packs

• Private label/branding (OEM/contract manufacturing)

• Moisture-protected export cartons

All packaging complies with country-specific regulatory guidelines.

Shelf-Life, Storage and Dosage Form

• Dosage Form: Hard Gelatin Capsules

• Strength: Clofazimine 100mg

• Shelf Life: 24–36 months (export-stable)

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

• Packing: 10×10 blister, bottle pack, or custom export packaging

Export Certifications Supporting International Distribution

Taj Pharma ensures global compliance through:

• WHO-GMP

• ISO 9001:2015 Quality System

• COPP from DCGI

• GLP & GMP certification

• Halal certification (on request)

• Regulatory dossier compliant with CTD/ACTD standards

• Environment-safe & CSR-compliant manufacturing

These certifications make Taj Pharma a top choice for NGOs, government procurement agencies, and international public health organizations.

Target Export Markets for Clofazimine Capsules 100mg

Taj Pharma exports Clofazimine Capsules 100mg to several key regions:

• Africa: Nigeria, Ethiopia, Tanzania, Kenya, Zambia

• Asia: Nepal, Sri Lanka, Bangladesh, Myanmar

• Middle East: Iraq, Yemen, UAE, Oman

• CIS: Uzbekistan, Kyrgyzstan, Kazakhstan

• Latin America: Guatemala, Peru, Bolivia, Honduras

• South Pacific: Papua New Guinea

The product holds strong demand in countries where leprosy and resistant TB treatment programs are prominent.

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

1. State-of-the-Art WHO-GMP & EU-Standard Manufacturing Plants

Taj Pharma’s manufacturing facility in Vapi, Gujarat is equipped with:

• Automated capsule filling lines

• ISO-class cleanrooms

• Air-handling units with HEPA filters

• Dedicated quality-control laboratories

• Analytical, microbiological & stability testing units

Every batch is tested thoroughly to ensure purity, potency, uniformity, and microbial safety.

2. Affordable Pricing with Zero-Compromise Quality

Taj Pharma is preferred globally because:

• Prices suitable for large national health programs

• Consistent high-purity API and robust formulation

• Strict QC/QA protocols

• Economically viable for tender supply & NGO procurement

3. Global Presence & Reliable Supply Chain Support

International buyers trust Taj Pharma for:

• Rapid shipment turnaround

• Full export documentation

• International logistics handling

• Consistent stock availability

• Large-scale production capacity

This ensures uninterrupted supply for health ministry programs and NGOs.

4. Top 20 Countries  

USA, UK, South Africa, Kenya, Nigeria, Ghana, Vietnam, Myanmar, Philippines, Bangladesh, Sri Lanka, Iraq, Yemen, Uzbekistan, Kazakhstan, Georgia, Peru, Bolivia, Ukraine, Cambodia

Technical Product Specification Table

Call to Action for Buyers & Distributors

If you are looking for a reliable Clofazimine Capsules 100mg Manufacturer in India, Taj Pharma is your trusted partner for bulk imports, tenders, government supply, or PCD franchise operations.

📩 Email: info@tajpharma.com
🌐 Website: www.tajpharma.com
🏭 Manufacturing Location: Vapi, Gujarat, India

Taj Pharma welcomes inquiries from:

• Importers

• International distributors

• Government procurement agencies

• NGOs & humanitarian organizations

• Tender contractors

• PCD Pharma franchise partners

Top 20 FAQs  

1. What is Clofazimine Capsules 100mg used for?
It is used to treat leprosy and certain inflammatory reactions related to it.

2. Who is the best Clofazimine Capsules 100mg Manufacturer in India?
Taj Pharma is widely recognized as the leading manufacturer and exporter.

3. Is the product WHO-GMP certified?
Yes, Taj Pharma manufactures in WHO-GMP compliant plants.

4. Can the product be exported globally?
Yes, Taj Pharma exports to 40+ countries.

5. What are the common side effects?
Skin discoloration, abdominal pain, nausea, diarrhea, and rashes.

6. What is the recommended storage condition?
Store below 25°C and away from direct light.

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

8. Does Taj Pharma offer dossier support?
Yes, full CTD/ACTD dossiers are provided.

9. Can Taj Pharma manufacture under private label?
Yes, OEM and custom branding are available.

10. Does Clofazimine cause skin discoloration?
Yes, temporary reddish-brown discoloration is common.

11. Is it safe during pregnancy?
Only if prescribed by a physician.

12. What packing options are available?
Blisters, bottles, and customized export packs.

13. Are bulk orders accepted?
Yes, Taj Pharma specializes in large-volume production.

14. Is it used for TB treatment?
In specific drug-resistant TB regimens.

15. How should the capsule be taken?
With food, preferably at the same time each day.

16. What if a dose is missed?
Take it when remembered unless close to next dose.

17. Can it be used long-term?
Yes, under medical supervision.

18. Does Taj Pharma support tender documentation?
Yes, including COPP, WHO-GMP, FSC, and more.

19. What export markets does Taj Pharma serve?
Africa, Asia, Middle East, CIS, and Latin America.

20. Why choose Taj Pharma for Clofazimine Capsules 100mg?
High quality, affordability, regulatory support, and vast global distribution.

As a leading Clofazimine Capsules 100mg Manufacturer & Exporter in India, Taj Pharma delivers world-class quality, affordable pricing, extensive regulatory support, and unmatched global supply capacity. For importers, NGOs, government agencies, and PCD distributors, Taj Pharma is the most reliable partner for consistent, high-efficiency pharmaceutical supply.