GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Dofetilide Capsule 0.125mg
B) Dofetilide Capsule 0.250mg
C) Dofetilide Capsule 0.500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Dofetilide Capsule 0.125mg
Each Hard gelatin capsule contains:
Dofetilide USP…………….......................0.125mg
Excipients………………………………………..q.s.

B) Dofetilide Capsule 0.250mg
Each Hard gelatin capsule contains:
Dofetilide USP…………….......................0.250mg
Excipients………………………………………..q.s.

C) 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

Dofetilide Capsule 0.25mg Technical Specification:

Product Name: Dofetilide Capsule
Brand Name: Generic
Strength: 0.125mg, 0.25mg, 0.5mg
Dosage Form: Capsules (Hard gelatin)
Route of Administration: Via Oral Route
Packing: 10s, 30s, 100s, 500s
Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use: Anti-arrhythmic
Indication: 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.
Storage: Store at 20° to 25°C (68° to 77°F)

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 0.25mg

What is Dofetilide?

Dofetilide is a selective Class III antiarrhythmic medication used primarily for:

  • Atrial fibrillation

  • Atrial flutter

  • Maintaining normal sinus rhythm

  • Controlling abnormal heartbeat

  • Improving cardiac function in high-risk patients

It works by slowing electrical signals in the heart, enabling the heartbeat to return to a steady rhythm. Due to its potency, it is available only via medical prescription.

Global Demand for Dofetilide Capsule 0.25mg

The worldwide prevalence of heart rhythm disorders—especially AFib—is increasing. This drives high demand for reliable antiarrhythmic medications like Dofetilide Capsule 0.25mg.

Countries in Asia, Africa, Latin America, the Middle East, Europe, and emerging markets depend heavily on India’s pharmaceutical exports, particularly from trusted companies like Taj Pharma, known for consistent international quality compliance.


Technical Advantages & Clinical Benefits

Taj Pharma’s Dofetilide Capsule 0.25mg offers:

  • High bioavailability

  • Accurate dose uniformity

  • WHO-GMP compliant manufacturing

  • Proven hemodynamic safety in heart failure patients

  • Global export-approved formulations

Common clinical benefits include:

  • Stabilizing irregular heart rhythms

  • Reducing hospitalizations related to arrhythmias

  • Supporting long-term cardiac health


In-Depth Details for Importers, Exporters & Pharmaceutical Buyers

International buyers prefer Taj Pharma due to complete regulatory support and export-ready documentation.


Regulatory Documentation Provided

Taj Pharma supplies a complete regulatory dossier for Dofetilide Capsule 0.25mg exports, including:

  • WHO-GMP Certificate

  • Certificate of Pharmaceutical Product (COPP)

  • Drug Master File (DMF)

  • CTD/ACTD Dossier

  • COA – Certificate of Analysis

  • MSDS – Safety Documentation

  • Stability Data

  • Free Sale Certificate

  • Batch Manufacturing Records

  • BE/Bioequivalence documentation (if applicable)

This ensures smooth registration in all regulated and semi-regulated markets.


Custom Packaging & Private Label Services

Taj Pharma offers fully customizable packaging options:

  • Alu-Alu blister packs

  • HDPE bottles

  • Bulk pack options

  • Export-grade cartons

  • Custom artwork & brand labeling

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


Shelf-Life, Storage & Dosage Form

  • Shelf-life: 24–36 months (export quality)

  • Storage: Below 25°C, protected from light & moisture

  • Dosage Form: Hard gelatin capsule, 0.25mg strength

  • Pack Size: Flexible as per market requirement


Export Certifications Provided

Taj Pharma ensures global compliance through:

  • WHO-GMP

  • EU-GMP (on request)

  • ISO 9001:2015

  • ISO 14001

  • ISO 45001

  • COPP for multiple countries

  • GMP compliance from regulatory authorities


Target Export Countries

Taj Pharma exports Dofetilide Capsule 0.25mg to:

  • Vietnam

  • Philippines

  • Myanmar

  • Afghanistan

  • Iraq

  • Iran

  • UAE

  • Yemen

  • Saudi Arabia

  • Oman

  • Kenya

  • Nigeria

  • Ghana

  • South Africa

  • Tanzania

  • Ethiopia

  • Uganda

  • Latin American nations

  • CIS countries

  • Caribbean markets


Why Taj Pharma Is the Most Trusted Dofetilide Capsule 0.25mg Manufacturer & Exporter

Taj Pharma’s market leadership is a combination of advanced science, stringent quality systems, and an extensive global network.


1. State-of-the-Art WHO-GMP Manufacturing

Taj Pharma operates ultra-modern facilities equipped with:

  • Automated production lines

  • HEPA-filtered cleanrooms

  • Zero-contamination environments

  • High-precision encapsulation machines

  • Advanced analytical laboratories

Each batch undergoes strict:

  • Potency testing

  • Purity checks

  • Dissolution profiling

  • Stability evaluation


2. Affordable Pricing with Global Quality

As a top Dofetilide Capsule 0.25mg manufacturer in India, Taj Pharma offers:

  • Competitive bulk export pricing

  • High-purity API sourcing

  • Strict cost control without compromising quality

This makes Taj Pharma the preferred partner for government tenders and private distributors.


3. Strong Global Distribution & Supply Chain

With decades of export experience, Taj Pharma provides:

  • Reliable on-time deliveries

  • Sea/Air freight logistics support

  • Complete export documentation

  • End-to-end supply chain coordination


  4. Top 20 Countries  

Nigeria || Kenya || Ghana || Uganda || South Africa || UAE || Saudi Arabia || Oman || Qatar|| Kuwait || Russia || Kazakhstan || Uzbekistan || Kyrgyzstan || Vietnam || Philippines || Myanmar || Sri Lanka || Peru || Chile ||


 Technical Product Specifications  

Parameter Details
Product Name Dofetilide Capsule 0.25mg
Manufacturer Taj Pharma India
Dosage Form Hard Gelatin Capsule
Strength 0.25mg
Standards IP/USP/International
Packaging Alu-Alu / Bottle / Bulk
Shelf Life 24–36 months
Storage Below 25°C, dry place
Indications Atrial fibrillation, atrial flutter
Certifications WHO-GMP, ISO, COPP
Availability Export / Domestic / PCD Franchise
Minimum Order As per buyer requirement

 Call to Action  

If you are a pharmaceutical importer, distributor, hospital procurement officer, or PCD franchise seeker, Taj Pharma offers:

✔ Best pricing for bulk & commercial quantities
✔ Global-standard quality
✔ Full regulatory support
✔ Fast worldwide shipping

📩 Contact Taj Pharma Today:
Email: info@tajpharma.com
Website: www.tajpharma.com
Location: Vapi, Gujarat, India

Partner with India’s most trusted manufacturer of Dofetilide Capsule 0.25mg and grow your pharmaceutical business confidently.


 Top 20 FAQs  

1. What is Dofetilide Capsule 0.25mg used for?

It treats atrial fibrillation and atrial flutter by restoring a normal heart rhythm.

2. Who is the best Dofetilide Capsule 0.25mg manufacturer in India?

Taj Pharma is the leading WHO-GMP certified manufacturer.

3. Is Dofetilide available for export?

Yes, Taj Pharma exports globally with full regulatory documentation.

4. Is customized packaging available?

Yes, private label, multilingual cartons, and branded designs are offered.

5. What certifications does Taj Pharma provide?

WHO-GMP, COPP, ISO, CTD dossier, COA, MSDS, etc.

6. What is the shelf-life?

24–36 months depending on packaging.

7. How should Dofetilide be stored?

In a cool, dry place below 25°C.

8. Does Taj Pharma provide PCD Franchise?

Yes, PAN India PCD opportunities are available.

9. What are the common side effects?

Swelling, shortness of breath, weight gain, fluid retention, dizziness.

10. Is Dofetilide safe for heart failure patients?

When used correctly, it is considered hemodynamically safe.

11. Does Taj Pharma supply tender quantities?

Yes, suitable for government and NGO tenders.

12. Can Taj Pharma export to regulated markets?

Yes, with CTD dossiers and regulatory support.

13. What is the minimum order quantity?

Flexible based on market needs.

14. Does Taj Pharma provide samples?

Available for eligible buyers and registrations.

15. What is the mode of shipment?

Air and sea freight both available.

16. Can labels be customized?

Yes, with complete design and branding support.

17. Which API standards are used?

IP/USP certified high-purity APIs.

18. Is emergency supply supported?

Yes, Taj Pharma handles urgent medical shipments.

19. Do you offer distributor prices?

Yes, competitive worldwide pricing.

20. How to order?

Email Taj Pharma with quantity and country details for a quotation.