Dofetilide Capsule 0.5mg

Dofetilide Capsule 0.5mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Dofetilide Capsule 0.125mg
• Dofetilide Capsule 0.250mg
• Dofetilide Capsule 0.500mg 

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• Dofetilide Capsule 0.125mg
  Each Hard gelatin capsule contains:
  Dofetilide USP………………………………..0.125mg
  Excipients………………………………………..q.s.
• Dofetilide Capsule 0.250mg
  Each Hard gelatin capsule contains:
  Dofetilide USP………………………………..0.250mg
  Excipients………………………………………..q.s.
• Dofetilide Capsule 0.500mg
  Each Hard gelatin capsule contains:
  Dofetilide USP………………………………..0.500mg
  Excipients………………………………………..q.s.

THERAPEUTIC INDICATIONS:

• Dofetilide is used to correct irregular heartbeat of patients with atrial fibrillation or atrial flutter to a normal heart rhythm. Dofetilide belongs to the group of medicines known as antiarrhythmics. It works by slowing nerve impulses in the heart.

CAUTION & WARNING:

• CAUTION: Dispense in well-closed containers.
  Read enclosed leaflet before use.
  Keep medicine out of reach of children.
  SWALLOW WHOLE DO NOT CHEW OR CRUSH
• Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only. 

STORAGE & DOSAGE:

• Storage: Store at 20° to 25°C (68° to 77°F).
• Dosage: As directed by the Physician

Attach dispensing label here

Introduction to Dofetilide Capsule 0.5mg

What is Dofetilide?

Dofetilide is a potent antiarrhythmic drug prescribed to:

• Convert atrial fibrillation into normal sinus rhythm

• Prevent AF recurrence

• Manage atrial flutter

• Support heart failure patients with rhythm abnormalities

It works by slowing electrical signals in the heart, enabling regular heartbeats.

Because of its powerful cardiac effects, Dofetilide is available only under a doctor’s prescription.

Global Demand for Dofetilide Capsule 0.5mg

Atrial fibrillation affects over 35+ million patients globally, making antiarrhythmic drugs vital for cardiac care. Countries across Asia, Africa, LATAM, Middle East, CIS, and Europe import Dofetilide Capsule 0.5mg due to increasing cardiac disease burdens.

This positions Indian manufacturers—especially Taj Pharma—as leading exporters known for reliability, cost-effectiveness, and compliance with international standards.

 Why Dofetilide Capsule 0.5mg Is Widely Used

Taj Pharma’s formulation is known for:

• High purity & potency

• Excellent bioavailability

• Stability under different climatic zones

• WHO-GMP–certified quality

Clinical benefits include:

• Stabilizing abnormal heart rhythms

• Reducing hospitalization risks

• Supporting long-term heart function

• Hemodynamic safety in heart failure patients

Patients should monitor symptoms like:

• Sudden weight gain

• Swelling in feet or abdomen

• Shortness of breath

• Discomfort when lying flat

These may indicate the need for immediate medical evaluation.

 In-Depth Details for Importers, Exporters & Buyers

Global pharmaceutical buyers prefer Taj Pharma due to its transparent documentation, strict regulatory adherence, and export readiness.

Regulatory Documentation Provided by Taj Pharma

Taj Pharma supplies complete regulatory and export documents for Dofetilide Capsule 0.5mg, including:

• WHO-GMP Certificate

• COPP (Certificate of Pharmaceutical Product)

• CTD/ACTD Dossier

• Master Formula Records

• Drug Master File (DMF)

• COA – Certificate of Analysis

• MSDS – Safety Sheet

• Stability Studies (Accelerated & Real-Time)

• FSC – Free Sale Certificate

• Packing List, Commercial Invoice, COO

All documents comply with international registration guidelines, making Taj Pharma the preferred partner for tender supplies and regulatory submissions.

Custom Packaging & Private Label Solutions

Taj Pharma provides flexible packaging options:

• Alu-Alu blister packs

• Bulk packaging for institutional supply

• HDPE / PET bottles

• Customized labeling

• Multilingual packaging (English, French, Arabic, Spanish)

• Tamper-proof export-grade cartons

• Contract manufacturing & OEM branding

Buyers can request custom pack sizes, artwork, and brand name printing.

Shelf-Life, Storage & Dosage Form

Export Certifications Provided

Taj Pharma supports global compliance through:

• WHO-GMP

• EU-GMP (on-demand)

• ISO 9001:2015

• ISO 14001

• ISO 45001

• COPP for multiple markets

• Test reports from NABL-certified labs

Target Export Markets

Taj Pharma supplies Dofetilide Capsule 0.5mg to:

• Middle East

• Africa

• South East Asia

• Latin America

• CIS markets

• European regions

• Caribbean Islands

• PAN India domestic distributors

 Why Taj Pharma Is the Most Trusted Dofetilide Capsule 0.5mg Manufacturer & Exporter

Taj Pharma is recognized globally for unmatched quality, supply reliability, and regulatory compliance.

 1. State-of-the-Art Manufacturing Facilities

Taj Pharma operates globally accredited units featuring:

• Fully automated lines

• HEPA-filtered cleanrooms

• High-precision encapsulation

• Microbial & chemical testing labs

• Zero-contamination controlled environments

Every batch undergoes:

• Dissolution testing

• Stability profiling

• Uniformity of weight & content

• Impurity analysis

This ensures consistent, reliable therapeutic performance.

  2. Competitive & Affordable Pricing

Being an Indian WHO-GMP-certified manufacturer, Taj Pharma offers:

• Best export pricing

• Cost-effective bulk supply

• Quality-driven formulation

• High-purity API procurement

This makes Taj Pharma ideal for government tenders, NGOs, hospitals, and private distributors.

 3. Global Logistics & Supply Chain Support

Taj Pharma supports worldwide clients through:

• Doorstep delivery

• Air/Sea freight coordination

• Export documentation

• Cold-chain and ambient shipping

• Dedicated export managers

  4. Top 20 Countries 

India | Vietnam | UAE | Saudi Arabia | Kenya | Tanzania | Nigeria | Philippines | Cambodia | Ghana | Peru | Colombia | Uzbekistan | Kazakhstan | Sri Lanka | Myanmar | Yemen | Oman | South Africa | Chile

 Technical Product Specification Table  

 Call to Action:  

Taj Pharma welcomes pharmaceutical distributors, importers, hospital networks, and PCD franchise seekers to collaborate.

📞 Contact Taj Pharma:
Email: info@tajpharma.com
Website: www.tajpharma.com
Head Office: Vapi, Gujarat, India

✔ Global export support
✔ Competitive pricing
✔ WHO-GMP certified manufacturing
✔ 100% regulatory compliance

Grow your pharmaceutical business with India’s most trusted Dofetilide Capsule 0.5mg manufacturer.

  Top 20 FAQs  

1. What is Dofetilide Capsule 0.5mg used for?

It treats atrial fibrillation and atrial flutter.

2. Who is the top manufacturer in India?

Taj Pharma is the leading WHO-GMP-certified manufacturer.

3. Is export documentation provided?

Yes—CTD dossier, COPP, COA, MSDS, stability data, etc.

4. Can packaging be customized?

Yes, with private labeling and multilingual printing.

5. Is the product WHO-GMP certified?

Absolutely. Taj Pharma offers WHO-GMP, ISO, and COPP certifications.

6. Is Dofetilide safe for heart failure?

Clinical evidence supports hemodynamic safety under medical supervision.

7. Does Taj Pharma offer PCD Pharma Franchise?

Yes, PAN India franchise support is available.

8. What is the usual shelf-life?

Up to 36 months.

9. Do you supply hospital bulk orders?

Yes, bulk institutional supply is available.

10. Can I get free samples for registration?

Yes, for eligible importers.

11. Is it available in Mumbai?

Yes, Taj Pharma supplies across Mumbai and Maharashtra.

12. What is the mode of shipment?

Air or sea freight.

13. Do you provide artwork support?

Yes, complete branding solutions are offered.

14. Does Taj Pharma export to Africa?

Yes, to more than 20 African nations.

15. Is 0.5mg strength widely demanded internationally?

Yes, it is the most prescribed strength for AF management.

16. What is the minimum order?

Flexible MOQ as per buyer requirements.

17. Are analytical reports included?

Yes, COA and full test reports provided.

18. Can you support country registrations?

Yes, with dossiers and stability data.

19. Is Taj Pharma API self-manufactured?

High-purity approved API sources are used.

20. How do I place an order?

Send your requirement to info@tajpharma.com for a quotation.

Taj Pharma stands as the top Dofetilide Capsule 0.5mg Manufacturer in India, offering world-class quality, affordability, and compliance with global pharmaceutical standards. Whether you are a distributor, hospital procurement team, or international importer, Taj Pharma delivers unmatched reliability and expertise.