Fenofibrate Tablet 54mg

Fenofibrate Tablet 54mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Fenofibrate Tablet USP 40mg
  
• Fenofibrate Tablet USP 48mg
• Fenofibrate Tablet USP 54mg
• Fenofibrate Tablet USP 120mg
• Fenofibrate Tablet USP  160mg

 QUALITATIVE AND QUANTITATIVE COMPOSITION:

• a) Fenofibrate Tablet USP 40mg
  Each Film coated Tablet contains:
  Fenofibrate USP…………………….40mg
  Excipients………………………………q.s.
  Colour: Titanium Dioxide
• b) Fenofibrate Tablet USP 48mg
  Each Film coated Tablet contains:
  Fenofibrate USP……………………………48mg
  Excipients……………………………………. q.s.
  Colour: Iron Oxide Red
• c) Fenofibrate Tablet USP 54mg
  Each Film coated Tablet contains:
  Fenofibrate USP ……………………………54mg
  Excipients……………………………….……q.s.
  Colour: Iron Oxide Yellow.
• d) Fenofibrate Tablet USP 120mg
  Each Film coated Tablet contains:
  Fenofibrate USP ……………………………120mg
  Excipients…………………………………… q.s.
  Colour: Iron Oxide Black
• e) Fenofibrate Tablet USP 160mg
  Each Film coated Tablet contains:
  Fenofibrate USP …………………………160mg
  Excipients…………………………………q.s.
  Colour: FD&C Blue (Indigo Carmine)

 THERAPEUTIC INDICATIONS:

• Fenofibrate is used along with a proper diet to help lower “bad” cholesterol and fats (such as LDL, triglycerides) and raise “good” cholesterol (HDL) in the blood.

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 in the original package. Do not store above 25°C.
  Keep container in a well-ventilated place. Keep away from sources of ignition and heat.
• Dosage:  As directed by the Physician.

Introduction to Fenofibrate Tablets 54mg

Fenofibrate Tablets 54mg are a widely prescribed lipid-modifying agent used in the management of elevated triglycerides and cholesterol levels. This medication belongs to the fibrate class and acts by increasing the activity of an enzyme that helps to break down fats in the bloodstream. Primarily, Fenofibrate Tablets 54mg are indicated for patients with hypertriglyceridemia and mixed dyslipidemia. By significantly reducing triglycerides and modestly improving HDL (good cholesterol), it helps in lowering the risk of cardiovascular diseases and pancreatitis caused by extremely high triglyceride levels. With a global rise in metabolic syndrome, obesity, and sedentary lifestyle diseases, the demand for lipid-lowering drugs like Fenofibrate has seen exponential growth, particularly in regions like Latin America, the Middle East, Africa, and Southeast Asia.

Product Overview Fenofibrate Tablets 54mg

Taj Pharma is a renowned name among Fenofibrate Tablets 54mg manufacturers in India, known for delivering medications that meet the highest quality standards. Fenofibrate Tablets 54mg manufactured by Taj Pharma, are well-tolerated, safe, and effective, with consistent pharmacokinetics ensuring a full-day effect. As a daily dosage therapy, the formulation is designed to maintain steady plasma levels, making it an ideal solution for long-term lipid control therapy. Its precise composition, high purity, and compliance with global pharmacopeial standards make it a top choice for both physicians and procurement agencies worldwide.

Global Supply and Regulatory Compliance for Buyers & Importers

Taj Pharma caters to a diverse global clientele, including importers, institutional buyers, hospitals, government tenders, and distributors across more than 40 countries. One of the major advantages of sourcing from Taj Pharma is the availability of comprehensive regulatory documentation that simplifies the product registration process across international markets.

Taj Pharma provides full regulatory support for Fenofibrate Tablets 54mg, including:

• Certificate of Pharmaceutical Product (COPP)

• WHO-GMP Certificate

• EU-GMP and PICS-compliant documentation

• CTD/ACTD dossiers with bioequivalence data where applicable

• Stability data as per ICH guidelines

• Batch Manufacturing Records (BMR) and Product Quality Reviews (PQRs)

Additionally, Taj Pharma supports custom packaging and private labeling, enabling importers to meet country-specific branding and language requirements. The product is typically offered in Alu-Alu or blister packaging, with a shelf life of 24 to 36 months under controlled storage conditions (below 25°C, away from moisture). Dosage form is oral solid tablet, administered once daily unless directed otherwise by the physician.

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

Taj Pharma stands out as the most trusted Fenofibrate Tablets 54mg manufacturer in India for several key reasons:

🌐 World-Class Manufacturing Facilities

Taj Pharma operates a WHO-GMP and ISO 9001:2015-certified facility in Vapi, Gujarat. The plant follows stringent quality control protocols at every stage—from raw material procurement to finished dosage formulation and packaging. Equipped with advanced analytical instruments and automatic tablet compression lines, the infrastructure ensures consistency, purity, and precision in every batch.

💲 Competitive Pricing with Quality Guarantee

One of Taj Pharma’s biggest advantages lies in its cost-effective production model. Without compromising quality, the company is able to offer Fenofibrate Tablets 54mg at highly competitive prices due to bulk manufacturing efficiencies and vertically integrated supply chains.

🌍 Wide Global Presence

Taj Pharma’s active pharmaceutical export footprint extends to Africa, Latin America (LATAM), CIS countries, the Middle East, and Southeast Asia. The company also holds strong partnerships with procurement agencies such as UNICEF, UNDP, and various Ministries of Health globally.

🌎 Top 20 Export Markets for Fenofibrate Tablets 54mg

Nigeria, Kenya, Ghana, UAE, Saudi Arabia, Iraq, Brazil, Chile, Peru, Colombia, Myanmar, Cambodia, Uzbekistan, Kazakhstan, Ukraine, Sri Lanka, Yemen, Sudan, South Africa, Vietnam

These countries rely on Taj Pharma not only for their commitment to quality-assured supply of Fenofibrate Tablets 54mg, but also for seamless documentation, timely dispatch, and market-specific regulatory support.

 Technical Product Specification Table

Call to Action for Buyers, Distributors, and PCD Partners

If you’re seeking a reliable, WHO-GMP certified Fenofibrate Tablets 54mg manufacturer in India, look no further than Taj Pharma. With a reputation built on trust, compliance, and customer satisfaction, Taj Pharma delivers not only products but also complete support—from technical dossiers to logistics and regulatory assistance.

📞 Contact Us Today
Partner with one of the most reliable pharmaceutical companies in India. For Fenofibrate Tablets 54mg manufacturing, PCD franchise, or export inquiries, reach out today.

📧 Email: info@tajpharma.com
📱 Phone: +91 84484 44095
📲 WhatsApp: +91 7400009975 / +91 7400009976
🌐 Website: www.tajpharmaindia.com

Top 20 FAQs on Fenofibrate Tablets 54mg

1. What are Fenofibrate Tablets 54mg used for?

Fenofibrate Tablets 54mg are used to reduce elevated triglycerides and cholesterol levels in the blood.

2. How does Fenofibrate work?

It increases lipoprotein lipase activity, which breaks down triglyceride-rich particles in the blood.

3. Is Fenofibrate 54mg safe for long-term use?

Yes, it is considered safe for long-term therapy when monitored regularly by a physician.

4. Can Fenofibrate Tablets 54mg be taken with food?

Yes, it is best taken with meals to enhance absorption.

5. Are there any side effects?

Common side effects include abdominal pain, nausea, muscle pain, and slight elevations in liver enzymes.

6. Can it be used in kidney patients?

Caution is required; it is contraindicated in severe renal impairment.

7. What is the shelf life of Fenofibrate Tablets 54mg?

Typically between 24 to 36 months under recommended storage.

8. Can Taj Pharma provide CTD dossiers?

Yes, Taj Pharma provides full CTD/ACTD dossiers for registration purposes.

9. What packaging options are available?

Alu-Alu and blister pack configurations are standard.

10. Is private labeling available?

Yes, Taj Pharma offers custom packaging and labeling services.

11. Are these tablets WHO-GMP certified?

Yes, manufactured in a WHO-GMP-approved facility.

12. What is the usual dosage?

Typically one tablet of 54mg per day, or as prescribed by a physician.

13. Can it be co-administered with statins?

Caution is advised due to potential muscle-related side effects.

14. What countries does Taj Pharma export to?

Over 40 countries across Africa, LATAM, Middle East, CIS, and Asia.

15. Is bioequivalence data available?

Yes, upon request for certain tenders and registrations.

16. What is the cost advantage of sourcing from India?

India offers cost-efficient production without compromising quality, especially from companies like Taj Pharma.

17. How long does it take to receive export documentation?

Typically within 7–10 working days from order confirmation.

18. Can Taj Pharma supply large volumes?

Yes, with scalable production to meet bulk orders and institutional tenders.

19. Are there storage instructions?

Store below 25°C in a dry place, away from sunlight.

20. How to order from Taj Pharma?

Simply contact the team via phone, email, or WhatsApp for quotation and documentation support.