GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Flecainide Acetate Tablet USP 50mg
B) Flecainide Acetate Tablet USP 100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Flecainide Acetate Tablet USP 50mg
Each Un-coated tablet contains:
Flecainide Acetate USP……………..………....50mg
Excipients …………………………………..…….……q.s

B) Flecainide Acetate Tablet USP 100mg
Each Un-coated tablet contains:
Flecainide Acetate USP……………..………....100mg
Excipients …………………………………..…….……q.s

THERAPEUTIC INDICATIONS:

Flecainide acetate is a Class IC antiarrhythmic agent used for the treatment of severe symptomatic life-threatening ventricular arrhythmias and supraventricular arrhythmias. Electrophysiologically, flecainide is a local anaesthetic-type (Class IC) of antiarrhythmic compound.

CAUTION & WARNING:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
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.

Flecainide Acetate Tablet  100mg Technical Specification:

Product Name: Flecainide Acetate Tablet USP
Brand Name: Generic
Strength: 50mg, 100mg
Dosage Form: Tablets (Film-coated)
Route of Administration: Via Oral Route
Packing: 10s, 20s, 30s, 50s, 100s
Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use: Antiarrhythmic
Indication: Flecainide acetate is a Class IC antiarrhythmic agent used for the treatment of severe symptomatic life-threatening ventricular arrhythmias and supraventricular arrhythmias. Electrophysiologically, flecainide is a local anaesthetic-type (Class IC) of antiarrhythmic compound.
Storage: Store at 20° to 25°C (68° to 77°F).

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Flecainide Acetate Tablet USP 50mg
  • Flecainide Acetate Tablet USP 100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Flecainide Acetate Tablet USP 50mg
    Each Un-coated tablet contains:
    Flecainide Acetate USP……………..………….50mg
    Excipients …………………………………..…….……q.s
  • Flecainide Acetate Tablet USP 100mg
    Each Un-coated tablet contains:

    Flecainide Acetate USP……………..………….100mg
    Excipients …………………………………..…….……q.s

THERAPEUTIC INDICATIONS:

  • Flecainide acetate is a Class IC antiarrhythmic agent used for the treatment of severe symptomatic life-threatening ventricular arrhythmias and supraventricular arrhythmias. Electrophysiologically, flecainide is a local anaesthetic-type (Class IC) of antiarrhythmic compound.

CAUTION & WARNING:

  • CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH.
    Read enclosed leaflet before use.
    Keep medicine out of reach of children.
  • 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 Flecainide Acetate Tablet 100mg

What Is Flecainide Acetate 100mg?

Flecainide Acetate is a Class IC antiarrhythmic drug that works by blocking abnormal electrical signals within the heart. This helps restore normal cardiac rhythm and prevent dangerous arrhythmias. It is often prescribed for conditions such as:

  • Ventricular arrhythmia

  • Supraventricular tachycardia (SVT)

  • Paroxysmal atrial fibrillation

  • Paroxysmal supraventricular tachycardia

Global Demand

Global demand for Flecainide Acetate 100mg continues to grow due to:

  • Rising cardiovascular disease incidence

  • Increasing geriatric population

  • Higher diagnostic rates

  • Greater availability of cardiac care facilities

Countries in Asia, Africa, Europe, South America, and the Middle East have increased their import volumes, making India a primary source for high-quality antiarrhythmic medicines.

Why Medical Professionals Prefer It

  • High efficacy in stabilizing cardiac rhythm

  • Predictable pharmacokinetics

  • Long-term safety

  • FDA, EMA, and WHO guidelines-based formulation standards

Taj Pharma ensures premium-grade quality and strict adherence to pharmacopeial standards, making it a top choice for global purchases.


 In-Depth Details for Importers, Exporters & Global Buyers

Global buyers looking for a trustworthy Flecainide Acetate Tablet 100mg supplier need high-quality pharmaceutical products backed by documentation, certifications, and professional export support. Taj Pharma fulfills all international regulatory requirements essential for importing pharmaceutical formulations.


  Regulatory Documentation Provided

Taj Pharma supplies complete export-ready documentation including:

  • WHO-GMP Certificate

  • COA (Certificate of Analysis)

  • MOA (Method of Analysis)

  • COPP (Certificate of Pharmaceutical Product)

  • Drug Master File (DMF) on request

  • Stability studies (Zone II–IV)

  • CTD / ACTD dossiers

  • Free Sale Certificate (FSC)

  • Batch Manufacturing Records (BMR)

  • MSDS

  • Commercial Invoice, Packing List, COA

This ensures hassle-free import clearance for both regulated and semi-regulated markets.


 Custom Packaging & Labeling Options

Taj Pharma offers tailor-made packaging solutions:

  • Multi-language labeling

  • Blister packs, bottles, or bulk packaging

  • Temperature-stable export-grade cartons

  • Tamper-proof sealing

  • Custom artwork for private labeling

  • Branding support for distributors & PCD franchise partners

All packaging meets international shipping standards.


  Shelf-Life, Storage & Dosage Form

  • Dosage Form: Oral solid tablet

  • Strength: 100mg

  • Shelf-life: 24–36 months

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

  • Color & Shape: As per customer/regulatory requirements


 Export Certifications

Taj Pharma facilities comply with global pharmaceutical norms:

  • WHO-GMP Certified

  • EU-GMP aligned processes

  • ISO 9001:2015 Certified

  • GLP Certified

  • COPP for global exports

  • CTD & ACTD Dossier support

These certifications make Taj Pharma an automatic preference for distributors across 40+ export markets.


 Target Countries & Export Markets

Taj Pharma has a strong footprint in:

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

Taj Pharma is rapidly expanding to regulated markets including Europe and Latin America with dossier submissions under process.


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

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

Taj Pharma’s ultra-modern facilities ensure:

  • Automated production lines

  • Zero-human-contact packaging

  • Dedicated QC & QA labs

  • Real-time stability chambers

  • Strict compliance with Indian & International Pharmacopeia

Each batch undergoes over 37 quality checks before final shipment.


  2. Affordable Pricing with Unmatched Quality

With bulk API sourcing, high-efficiency production lines, and optimized logistics, Taj Pharma offers:

  • Lowest manufacturing cost

  • Competitive export pricing

  • Large-scale batch production

  • Consistent supply


 3. Global Presence & Reliable Supply Chain

Taj Pharma ensures:

  • Smooth export documentation

  • Fast order processing

  • Flexible MOQ

  • Multi-country regulatory support

  • Technical support for registrations

Buyers benefit from a reliable worldwide distribution network.


  4. Top 20 Export 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 Specification Table

Parameter Details
Product Name Flecainide Acetate Tablet
Strength 100mg
Manufacturer Taj Pharma Ltd., Vapi, Gujarat
Composition Flecainide Acetate 100mg
Indication Arrhythmia, Ventricular tachycardia
Dosage Form Tablet
Packaging Blister / Bottle / Bulk
Shelf-Life 24–36 months
Storage <25°C, dry place
Certification WHO-GMP, ISO, EU-GMP aligned
Export Support Dossier, COA, COPP, FSC

  Call to Action for Importers & Distributors

If you are looking for the best Flecainide Acetate Tablet 100mg manufacturer in India, Taj Pharma is your trusted partner.

📞 Contact Taj Pharma Ltd.
🌍 Website: www.tajpharma.com
📧 Email: info@tajpharma.com
📦 Bulk orders | 💊 PCD franchise | 🌐 Export partnerships

Taj Pharma guarantees premium quality, global regulatory support, timely delivery, and competitive pricing.


 Top 20 FAQs  

  1. What is Flecainide Acetate 100mg used for?
    Treats ventricular arrhythmia and supraventricular tachycardia.

  2. Is it a prescription medicine?
    Yes, it requires medical supervision.

  3. How does it work?
    It blocks sodium channels, stabilizing cardiac rhythm.

  4. What are common side effects?
    Dizziness, heart failure, ventricular arrhythmia.

  5. Is Taj Pharma a WHO-GMP certified manufacturer?
    Yes, WHO-GMP and ISO certified.

  6. What’s the shelf-life?
    24–36 months.

  7. Does Taj Pharma offer a dossier?
    Yes—CTD/ACTD dossiers available.

  8. Is bulk export available?
    Yes, worldwide shipping.

  9. Does it treat atrial fibrillation?
    Yes, in selected cases.

  10. Is private labeling possible?
    Yes, fully customizable.

  11. Does Taj Pharma support PCD Franchise?
    Yes, across India.

  12. Can it be used long-term?
    Only under medical supervision.

  13. What certifications does Taj Pharma offer?
    WHO-GMP, ISO, COPP, FSC, CTD Dossiers.

  14. Is custom packaging available?
    Yes, multilingual and export-friendly.

  15. Are stability studies available?
    Yes, Zone II–IV chambers.

  16. Is it suitable for pediatric use?
    Only if prescribed by a doctor.

  17. What storage conditions are recommended?
    Below 25°C, protected from light.

  18. Is it exported internationally?
    Yes, to 20+ countries.

  19. Can distributors get promotional support?
    Yes, through Taj Pharma PCD program.

  20. Why choose Taj Pharma?
    Highest quality, best pricing, global support.