Dofetilide Capsule 0.125mg

Dofetilide Capsule 0.125mg 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 0.125mg

Dofetilide Capsule 0.125mg is an FDA-approved Class III antiarrhythmic medication used to restore and maintain normal heart rhythm. It works by slowing nerve impulses in the heart, stabilizing electrical activity, and reducing irregular heartbeat episodes.

Primary Uses

• Atrial fibrillation (AF)

• Atrial flutter

• Prevention of AF recurrence

• Rhythm stabilization in high-risk cardiac patients

Why It’s in High Demand Globally

• Rising cardiovascular diseases

• Increased adoption of advanced arrhythmia management

• Preference for safe and monitored antiarrhythmic agents

• High requirement in hospitals, cardiology centers, and government tenders

Taj Pharma ensures a steady global supply of Dofetilide Capsule 0.125mg meeting international therapeutic standards and pharmacovigilance requirements.

  Comprehensive Details for Importers, Exporters & Pharmaceutical Buyers

For global buyers, accessing compliant documentation and export-ready formulations is essential. Taj Pharma offers complete regulatory, quality, and packaging support for seamless import clearance.

Regulatory Documentation Provided

Taj Pharma supplies a full regulatory support package, including:

• WHO-GMP Certificate

• EU-GMP (available for select facilities)

• Certificate of Pharmaceutical Product (COPP)

• CTD/eCTD Dossier

• Stability data (real-time & accelerated)

• Batch Manufacturing Records (BMR)

• Free Sale Certificate (FSC)

• COA, MSDS, MOA

• BE/Clinical data (as applicable)

Custom Packaging & Labeling

Buyers can request:

• Private-label manufacturing

• Country-specific regulatory artwork

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

• Aluminum-aluminum, blister, or HDPE packaging

Shelf-Life & Storage

• Shelf life: 24–36 months (depending on market requirement)

• Storage: Store below 30°C, protect from moisture and light

• Dosage form: Hard gelatin capsule, extended-release

Export Certifications

Taj Pharma exports Dofetilide Capsule 0.125mg with:

• WHO-GMP certification

• ISO 9001:2015 quality systems

• COPP for multiple countries

• DMF/Technical Dossier support

• PIC/S compliant manufacturing

• Third-party inspection support (SGS, Intertek, BV)

Target Countries & Export Markets

Taj Pharma exports to:

• Latin America

• Middle East

• South Africa & North Africa

• CIS Nations

• Southeast Asia

• Eastern Europe

• Central Asia

• Caribbean Islands

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

As a global leader in pharmaceutical manufacturing, Taj Pharma delivers industry-leading standards in quality, affordability, and supply chain reliability for Dofetilide Capsule 0.125mg.

State-of-the-Art Manufacturing

Taj Pharma Vapi, Gujarat facility is equipped with:

• Automated capsule filling machinery

• HEPA-filtered cleanrooms

• USFDA-aligned quality systems

• High-precision dissolution & stability chambers

• End-to-end digital batch monitoring

Affordable Pricing with High Purity Guarantee

Taj Pharma maintains:

• Cost-effective bulk production

• High assay purity

• Zero contamination protocols

• Strict adherence to pharmacopeial standards (USP/EP)

Global Presence & Efficient Supply Chain

Taj Pharma maintains:

• Export presence in 40+ countries

• Seamless freight management

• Cold-chain & temperature-controlled shipping

• Ready-to-dispatch stock for urgent export

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 

 Call to Action  

For international distributors, wholesalers, and government procurement agencies seeking a reliable Dofetilide Capsule 0.125mg manufacturer in India, Taj Pharma is your trusted partner.

Contact Taj Pharma for:

• Bulk inquiries

• Export orders

• Third-party manufacturing

• PCD Pharma franchise

• Hospital tenders & institutional supply

Taj Pharma guarantees quality, transparency, and uninterrupted supply of Dofetilide Capsule 0.125mg worldwide.

 Top 20 FAQs 

1. What is Dofetilide Capsule 0.125mg used for?

It treats atrial fibrillation and atrial flutter by stabilizing heart rhythm.

2. Is Taj Pharma a WHO-GMP certified manufacturer?

Yes, Taj Pharma operates fully WHO-GMP compliant facilities.

3. Can buyers request private labelling?

Yes, Taj Pharma offers customized branding and packaging.

4. Do you provide CTD dossiers for registration?

Yes, complete CTD/eCTD dossiers are available.

5. What is the minimum export order?

MOQ depends on packaging—typically one commercial batch.

6. Is Dofetilide Capsule 0.125mg available for PCD Pharma franchise?

Yes, nationwide PCD distribution is available.

7. What storage conditions are required?

Store below 30°C, away from moisture and sunlight.

8. What pharmacopeia standards are followed?

USP/EP standards depending on buyer requirement.

9. Do you export to regulatory markets?

Yes—Asia, Africa, CIS, Latin America, and more.

10. What is the usual shelf life?

24–36 months.

11. Is stability data provided?

Yes, both accelerated and real-time data are available.

12. Can Taj Pharma handle urgent export shipments?

Yes, fast-track dispatch is supported.

13. What certifications are provided with shipments?

COA, COPP, FSC, GMP, MSDS, and more.

14. Does the product meet FDA requirements?

It adheres to internationally accepted quality norms.

15. Is temperature-controlled shipping available?

Yes, upon request.

16. Do you support government tender supply?

Yes, Taj Pharma participates in global tenders.

17. Are multilingual packs available?

Yes—Arabic, French, Spanish, etc.

18. Do you provide sample packs?

Yes, for regulatory bodies and commercial evaluation.

19. What markets demand Dofetilide most?

Cardiology centers, hospitals, and government health programs.

20. Why choose Taj Pharma over others?

Superior quality, regulatory support, competitive pricing, and global reliability.

Taj Pharma stands as the 1 Dofetilide Capsule 0.125mg manufacturer and exporter in India, offering unmatched quality, timely delivery, and comprehensive regulatory documentation for global buyers. With a proven track record across 40+ countries, Taj Pharma is the preferred partner for importing, distributing, and marketing Dofetilide worldwide.