Dronedarone HCl Tablet 400mg

Dronedarone HCl Tablet 400mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Dronedarone HCl Tablet USP 400mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• Dronedarone HCl Tablet USP 400mg
  Each uncoated tablet contains:
  Dronedarone HCl …………………….…400mg
  Excipients…………………………………….q.s

THERAPEUTIC INDICATIONS:

• Dronedarone is used to treat people who currently have normal heart rhythm, but have had atrial fibrillation in the past. Dronedarone decreases the risk that people who have this condition will need to be hospitalized to treat atrial fibrillation. Dronedarone is in a class of medications called antiarrhythmics

CAUTION & WARNING:

• CAUTION:  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 the unit-dose blister pack in this bottle with the cap tightly secured till both tablets have been consumed. Store at 20° to 25°C (68° to 77°F)
• Dosage: As directed by the Physician

Attach dispensing label here

Introduction to Dronedarone HCl Tablet 400mg

Dronedarone HCl Tablet 400mg is a modern anti-arrhythmic medication widely prescribed for the treatment of cardiac arrhythmias, particularly atrial fibrillation and atrial flutter. It works by regulating the electrical activity of the heart, preventing irregular heartbeats, and maintaining normal sinus rhythm. Globally, the demand for Dronedarone HCl Tablet 400mg has surged due to the rising prevalence of cardiovascular diseases and the increasing need for safer alternatives to traditional anti-arrhythmic drugs. Patients benefit from reduced hospitalization risk, improved heart function, and enhanced quality of life.

Taj Pharma, a renowned Dronedarone HCl Tablet 400mg manufacturer in India, guarantees high-quality formulations with strict adherence to purity, potency, and safety standards. The product is increasingly sought after by distributors, importers, and healthcare institutions worldwide due to its effectiveness and compliance with international quality standards.

Export & Supply Details for Importers and Global Buyers

Taj Pharma provides comprehensive services for international buyers of Dronedarone HCl Tablet 400mg, including:

• Regulatory Documentation: Complete dossiers (CTD/ACTD), COA, CPP, stability data, and GMP certificates for smooth global registration.

• Custom Packaging & Labeling: Flexible packaging options for bulk orders, private labeling, and brand-specific requirements.

• Shelf-Life & Storage: Each tablet maintains optimal potency with a shelf life of 24–36 months, stored at controlled room temperature.

• Export Certifications: WHO-GMP, EU-GMP, COPP, ISO, and other international compliance certifications ensure global acceptance.

• Target Countries & Markets: Africa, Middle East, LATAM, Southeast Asia, CIS countries, and Europe.

Taj Pharma’s expertise ensures that global buyers receive fully compliant Dronedarone HCl Tablet 400mg with all necessary regulatory support, secure packaging, and on-time delivery.

Why Taj Pharma is the Most Trusted Manufacturer and Exporter

Taj Pharma has established itself as the 1 Dronedarone HCl Tablet 400mg manufacturer in India through:

• State-of-the-Art Manufacturing: WHO-GMP–certified facilities in Vapi, Gujarat, equipped with advanced tableting, quality control, and packaging systems.

• Affordable Pricing & Quality Assurance: Competitive pricing without compromising on purity, potency, and efficacy.

• Global Presence & Supply Chain Support: Efficient logistics networks ensure timely delivery to hospitals, wholesalers, and distributors worldwide.

• Top 20 Export Countries: India’s trusted partner exporting to the USA, UK, Germany, France, Canada, Australia, UAE, Saudi Arabia, South Africa, Nigeria, Brazil, Mexico, Russia, Singapore, Malaysia, Egypt, Kenya, Thailand, Qatar, and Oman.

Taj Pharma combines high-quality standards, regulatory expertise, and global supply reliability, making it the preferred choice for Dronedarone HCl Tablet 400mg suppliers.

Technical Product Specification Table

Key Safety and Usage Information

• May cause nausea, vomiting, abdominal pain, fatigue, rash, diarrhea, and elevated liver enzymes.

• Can cause blurred vision; avoid driving until effects are known.

• Skin may become sensitive to sunlight; use sunscreen and protective clothing.

• Should be used under medical supervision, especially in patients with heart failure or liver conditions.

Call to Action for Buyers and Distributors

Global distributors, wholesalers, and healthcare institutions seeking a trusted Dronedarone HCl Tablet 400mg supplier from India can partner with Taj Pharma for high-quality, WHO-GMP–certified formulations. Contact Taj Pharma today for bulk orders, custom labeling, private-label solutions, and PCD franchise opportunities.

Top 20 FAQs  

1. What is Dronedarone HCl Tablet 400mg used for?
   Treatment of atrial fibrillation and atrial flutter.

2. Who can manufacture Dronedarone 400mg in India?
   Taj Pharma is a leading WHO-GMP manufacturer in India.

3. Can it be exported globally?
   Yes, Taj Pharma exports to Africa, Middle East, LATAM, CIS, Europe, and more.

4. What certifications does Taj Pharma provide?
   WHO-GMP, EU-GMP, COPP, ISO, CTD dossiers, CPP.

5. What is the shelf life?
   24–36 months under proper storage conditions.

6. Can I get custom packaging?
   Yes, Taj Pharma offers private labeling and custom packaging.

7. Are there side effects?
   Yes, may include nausea, diarrhea, fatigue, rash, blurred vision.

8. Is it safe for elderly patients?
   Yes, under medical supervision.

9. What is the dosage form?
   Tablet 400mg.

10. Where is it manufactured?
    Vapi, Gujarat, India.

11. Can it be included in hospital procurement?
    Yes, suitable for bulk hospital supply.

12. Is regulatory documentation provided?
    Yes, all necessary documents for export are provided.

13. What countries does Taj Pharma export to?
    Top 20 include USA, UK, Germany, France, UAE, Saudi Arabia, South Africa, Nigeria, Brazil, Mexico, Russia, Singapore, Malaysia, Egypt, Kenya, Thailand, Qatar, Oman, Australia, Canada.

14. Does it require prescription?
    Yes, always under medical supervision.

15. Can it be used in combination with other drugs?
    Only under doctor’s guidance.

16. Is Taj Pharma a reliable supplier?
    Yes, globally trusted with WHO-GMP certification.

17. What is the MOQ for export?
    Flexible; contact for details.

18. Can I get a PCD franchise?
    Yes, Taj Pharma provides PCD opportunities.

19. How long does delivery take?
    Depends on destination; Taj Pharma ensures timely dispatch.

20. Does it comply with international standards?
    Yes, fully compliant with EU-GMP, COPP, and WHO-GMP.