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 50mg 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.

Introduction to Flecainide Acetate Tablet 50mg – Uses, Benefits & Global Market Demand

Flecainide Acetate is a Class Ic antiarrhythmic drug. It works by blocking abnormal electrical signals in the heart, helping restore a normal and steady rhythm.

Therapeutic Benefits

  • Prevents life-threatening ventricular arrhythmias
  • Stabilizes heart conduction system
  • Improves cardiac rhythm regularity
  • Reduces episodes of tachycardia

Side Effects (Common but mild):

Heart failure, ventricular arrhythmia, dizziness, blurred vision, weakness, shortness of breath.

Most side effects reduce as the body adjusts to the medicine.

Global Demand Insight

The rising prevalence of cardiovascular disorders worldwide has significantly increased the demand for Flecainide Acetate Tablet 50mg. Many countries depend heavily on India’s pharmaceutical manufacturing capabilities, especially from companies like Taj Pharma that comply with WHO-GMP standards.

Taj Pharma is among the few Indian companies manufacturing Flecainide Acetate 50mg at export-grade quality—making it a top-choice supplier for global cardiology markets.


 Detailed Guide for Importers, Distributors & Buyers

As a top-tier manufacturer of cardiovascular and antiarrhythmic drugs, Taj Pharma ensures a seamless export-ready process tailored for global procurement teams.


 Regulatory Documentation Provided

Taj Pharma provides a full regulatory dossier package, including:

  • WHO-GMP Certificate
  • Certificate of Pharmaceutical Product (CoPP)
  • Free Sale Certificate (FSC)
  • Manufacturing License
  • CTD/ACTD Dossier
  • Stability Studies (ICH guidelines)
  • COA (Certificate of Analysis)
  • Batch Manufacturing Records (BMR/BPR)
  • Method of Analysis (MOA)
  • MSDS
  • Packing list, CO, BL, Invoice

Buyers can register the product quickly in their respective countries.


 Custom Packaging & Labeling Options

Taj Pharma supports:

  • Export-compliant packaging
  • Country-specific label customization
  • Tamper-proof blister strips
  • Alu/Alu or PVC/Alu blister packs
  • Bulk packaging for institutional tenders
  • Multilingual artwork support

  Shelf-Life, Storage & Dosage Form

  • Form: Film-coated tablet
  • Strength: Flecainide Acetate 50mg
  • Shelf-life: 24–36 months
  • Packaging: 10×10 blister packs or customized
  • Storage: Store below 25°C, away from moisture and light

 Export Certifications

Taj Pharma’s manufacturing facilities comply with international standards:

  • WHO-GMP Certified
  • ISO 9001:2015
  • ISO 14001
  • GLP Certified
  • EU-GMP aligned systems
  • cGMP facility

 Target Countries & Export Markets

Taj Pharma exports Flecainide Acetate Tablet 50mg to:

  • Middle East (UAE, Qatar, Kuwait, Oman)
  • Africa (Kenya, Ghana, Ethiopia, Nigeria, Tanzania)
  • CIS (Uzbekistan, Kazakhstan, Georgia)
  • Latin America (Peru, Bolivia, Chile)
  • South Asia (Nepal, Sri Lanka, Afghanistan)
  • ASEAN Countries

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

Taj Pharma stands out due to its strict quality frameworks, WHO-GMP-certified infrastructure, and dependable export operations.


 1. Advanced WHO-GMP Manufacturing Infrastructure

Taj Pharma’s facility includes:

  • High-standard sterile manufacturing lines
  • Fully automated machinery
  • Controlled cleanroom environments
  • Advanced QA/QC laboratories
  • Skilled workforce and pharmacists

Every tablet undergoes multiple purity and stability checks.


 2. Affordable & Transparent Pricing

Taj Pharma ensures:

  • Competitive manufacturing prices
  • Best export rates
  • PCD franchise pricing
  • Bulk dealer and tender rates

Despite premium quality, pricing remains globally competitive.


 3. Strong Supply Chain & Global Distribution

Taj Pharma delivers products with:

  • Efficient global logistics network
  • Fast export documentation processing
  • Strong supply capability for large orders
  • Sea & air freight options
  • Temperature-controlled shipments

 4. Top 20 Countries Taj Pharma Exports  

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 Table

Parameter Details
Product Name Flecainide Acetate Tablet 50mg
Manufacturer Taj Pharma, India
Drug Class Class Ic Antiarrhythmic
Strength 50mg
Indication Ventricular arrhythmia, SVT
Form Film-coated tablet
Packaging 10×10 blister (Custom)
Shelf-Life 2–3 years
Storage Store under 25°C
Compliance WHO-GMP, ISO, COA, COPP
Route of Administration Oral

  Call to Action  

If you are an importer, wholesaler, distributor, hospital procurer, or PCD franchise partner seeking a reliable supplier of Flecainide Acetate Tablet 50mg, Taj Pharma is your ideal partner.

Why Choose Taj Pharma?

  • WHO-GMP-certified
  • Competitive pricing
  • Guaranteed purity and stability
  • Fast global shipping
  • Full regulatory support

Contact Details:

Email:  info@tajpharma.com
Website: www.tajpharma.com
Address: Vapi, Gujarat – India


 Top 20 FAQs  

1. What is Flecainide Acetate Tablet 50mg used for?

It treats life-threatening arrhythmias, especially ventricular arrhythmia and SVT.

2. Is Taj Pharma a certified manufacturer?

Yes, Taj Pharma is WHO-GMP, ISO, GLP, and cGMP certified.

3. How does Flecainide work?

It blocks abnormal electrical signals in the heart to restore normal rhythm.

4. Is it safe for long-term use?

Only under a cardiologist’s supervision.

5. What are the common side effects?

Ventricular arrhythmia, heart failure symptoms, dizziness, blurred vision.

6. Does Taj Pharma provide export documentation?

Yes—complete CTD dossier, COA, COPP, FSC, BMR/BPR, and more.

7. Can buyers request custom packaging?

Yes, with multilingual labels and country-specific requirements.

8. Does Taj Pharma export globally?

Yes, to 80+ countries.

9. What is the shelf-life of Flecainide?

2–3 years depending on packaging.

10. Is Flecainide available for PCD franchise?

Yes, PAN India franchise available.

11. Can I order bulk quantities?

Yes, Taj Pharma specializes in bulk and tender supplies.

12. Is it affordable?

Taj Pharma offers the best prices among WHO-GMP manufacturers.

13. How is the medicine stored?

Below 25°C, protected from moisture.

14. Is private labeling possible?

Yes, for distributors and tender suppliers.

15. Does Taj Pharma offer sample batches?

Yes, provided on request.

16. Can Flecainide be shipped by air?

Yes, fully compliant for air freight.

17. What markets import Flecainide most?

Africa, Middle East, CIS, LATAM.

18. What class does Flecainide belong to?

Class Ic antiarrhythmic.

19. Is documentation fast?

Yes, export paperwork is processed quickly.

20. How can buyers place orders?

Contact Taj Pharma via email at  info@tajpharma.com.


Taj Pharma stands as the 1 Flecainide Acetate Tablet 50mg Manufacturer Supplier in India, delivering globally compliant, affordable, and high-purity antiarrhythmic formulations. With extensive export capability, stringent WHO-GMP manufacturing standards, and unmatched regulatory support, Taj Pharma remains the top choice for global pharmaceutical buyers, importers, and PCD franchise distributors.