Fenofibrate Tablet 54mg

Fenofibrate Tablet 54mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

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

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• a) Fenofibrate Tablet IP 40mg
  Each Film coated Tablet contains:
  Fenofibrate IP…………………….40mg
  Excipients………………………………q.s.
  Colour: Titanium Dioxide
• b) Fenofibrate Tablet IP 48mg
  Each Film coated Tablet contains:
  Fenofibrate IP……………………………48mg
  Excipients……………………………………. q.s.
  Colour: Iron Oxide Red
• c) Fenofibrate Tablet IP 54mg
  Each Film coated Tablet contains:
  Fenofibrate IP ……………………………54mg
  Excipients……………………………….……q.s.
  Colour: Iron Oxide Yellow.
• d) Fenofibrate Tablet IP 120mg
  Each Film coated Tablet contains:
  Fenofibrate IP ……………………………120mg
  Excipients…………………………………… q.s.
  Colour: Iron Oxide Black
• e) Fenofibrate Tablet IP 160mg
  Each Film coated Tablet contains:
  Fenofibrate IP …………………………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
  
• SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.

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 Tablet 54mg

Fenofibrate Tablet 54mg is a widely used lipid-lowering medicine from the fibrate class. It works by increasing the activity of enzymes that break down fats in the blood, thereby lowering triglycerides and low-density lipoprotein (LDL) cholesterol while boosting high-density lipoprotein (HDL) cholesterol levels. By improving lipid profiles, Fenofibrate 54mg reduces the risks of heart attacks, strokes, and pancreatitis in patients with severely high triglycerides.

Taj Pharma, the leading Fenofibrate Tablet 54mg Manufacturer in India, ensures the highest standards of quality, purity, and compliance. Manufactured at their WHO-GMP-certified plant in Vapi, Gujarat, these tablets meet stringent global pharmacopeia standards, making Taj Pharma the trusted choice for importers, distributors, and PCD pharma franchise partners worldwide.

The global demand for Fenofibrate Tablet 54mg is rising rapidly due to increasing cases of cardiovascular diseases, obesity, and diabetes. International buyers seek reliable suppliers who provide consistent quality, regulatory support, and competitive pricing—and Taj Pharma delivers on all counts.

Regulatory & Export Details for Importers, Exporters, and Buyers

When sourcing medicines like Fenofibrate Tablet 54mg, regulatory compliance, export documentation, and packaging flexibility are key. Taj Pharma provides all the necessary certifications and documentation required for smooth market entry in diverse global regions.

Regulatory Documentation Provided

• Certificate of Pharmaceutical Product (COPP)

• Drug Master File (DMF) / CTD Dossier

• Stability Data (Zone-specific ICH guidelines)

• Bioequivalence studies (where applicable)

• Batch Manufacturing & Quality Control Records

Custom Packaging & Labeling

• Private labeling and PCD franchise branding available.

• Multilingual labeling (English, French, Spanish, Arabic, etc.).

• Blister strips, bottle packs, or bulk export packaging tailored to buyer needs.

Shelf-Life, Storage & Dosage Form

• Dosage form: Film-coated tablet, 54mg

• Shelf life: 24–36 months

• Storage: Store in a cool, dry place below 30°C

Certifications Ensuring Global Compliance

• WHO-GMP certified manufacturing facility

• EU-GMP compliant systems

• ISO 9001:2015 certification

• COPP approvals for multiple countries

• Compliance with IP, BP, and USP pharmacopeia standards

Target Export Markets

Taj Pharma is a global player in pharmaceutical exports, with established networks across:

• Asia (Vietnam, Myanmar, Sri Lanka, Bangladesh, Philippines)

• Africa (Nigeria, Kenya, Tanzania, South Africa, Ghana)

• CIS countries (Russia, Ukraine, Kazakhstan)

• Middle East (UAE, Iraq, Saudi Arabia, Yemen)

• Latin America (Peru, Chile, Brazil, Colombia)

Why Taj Pharma is the Most Trusted Fenofibrate Tablet 54mg Manufacturer, Supplier, and Exporter

1. State-of-the-Art Manufacturing

• Based in Vapi, Gujarat, India, Taj Pharma operates WHO-GMP-certified plants with cutting-edge technology.

• Automated production lines ensure consistency, contamination-free environments, and top-quality products.

2. Affordable Pricing with Quality Assurance

• Competitive pricing model designed for bulk buyers and global distributors.

• Zero tolerance for quality deviations—every batch is tested for potency, stability, and purity.

3. Strong Global Presence & Supply Chain Support

• Exports to 40+ countries across Asia, Africa, CIS, Middle East, and Latin America.

• Efficient supply chain ensures timely delivery and hassle-free regulatory clearances.

4. Top 20 Exporting Countries

Nigeria, Kenya, Ghana, South Africa, Tanzania, Uganda, Philippines, Vietnam, Myanmar, Sri Lanka, Nepal, UAE, Saudi Arabia, Iraq, Yemen, Kazakhstan, Uzbekistan, Peru, Bolivia, Chile

Technical Product Specification 

If you are looking for a reliable Fenofibrate Tablet 54mg Manufacturer, Supplier, or Exporter in India, Taj Pharma is your trusted partner.

With WHO-GMP-certified plants, global export compliance, affordable pricing, and efficient logistics, Taj Pharma guarantees consistent quality and regulatory support for importers, distributors, and PCD franchise partners.

👉 Contact Taj Pharma today for bulk procurement, private labeling, tender supplies, or PCD Pharma Franchise opportunities in Fenofibrate Tablet 54mg.

Top 20 FAQs  

Q1. What is Fenofibrate Tablet 54mg used for?
A1. It is used to lower triglycerides and cholesterol, reducing risks of heart disease and pancreatitis.

Q2. Who is the leading Fenofibrate Tablet 54mg Manufacturer in India?
A2. Taj Pharma, based in Vapi, Gujarat, is the top manufacturer and exporter.

Q3. How does Fenofibrate 54mg work?
A3. It enhances enzymes that break down fats, lowering triglycerides and LDL while increasing HDL.

Q4. Can patients with kidney disease take Fenofibrate?
A4. It is contraindicated in severe kidney disease and requires monitoring in mild-to-moderate cases.

Q5. What are the common side effects?
A5. Abdominal pain, diarrhea, nausea, headache, flatulence, vomiting, elevated liver enzymes, and back pain.

Q6. How should Fenofibrate be taken?
A6. With food, once daily, at the same time each day.

Q7. Is Fenofibrate Tablet 54mg safe during pregnancy?
A7. Not recommended unless prescribed by a doctor.

Q8. Can Fenofibrate be taken with alcohol?
A8. No, alcohol should be avoided as it increases liver risks.

Q9. How soon does it lower triglycerides?
A9. Noticeable effects are seen within a few weeks of regular use.

Q10. Is Fenofibrate safe with statins?
A10. Only under medical supervision due to increased risk of muscle side effects.

Q11. What is the shelf life of Fenofibrate 54mg?
A11. 24–36 months depending on storage conditions.

Q12. Can it be taken at night?
A12. Yes, it can be taken any time, but consistently at the same time daily.

Q13. Does Taj Pharma provide regulatory dossiers?
A13. Yes, CTD dossiers and COPPs are provided.

Q14. What packaging options are available?
A14. Blister packs, bottle packs, and export-specific bulk packs.

Q15. Is Fenofibrate Tablet 54mg available for PCD Pharma Franchise?
A15. Yes, Taj Pharma offers nationwide franchise opportunities.

Q16. Can Taj Pharma export to Latin America?
A16. Yes, with regulatory support for Brazil, Colombia, Peru, and Chile.

Q17. Is Fenofibrate effective in weight management?
A17. Preclinical studies suggest reduction in adiposity, but human use is focused on lipid lowering.

Q18. How does Taj Pharma ensure quality?
A18. Through WHO-GMP-certified plants, stringent QC, and batch-wise testing.

Q19. Can Fenofibrate reduce pancreatitis risk?
A19. Yes, in patients with very high triglycerides.

Q20. How can distributors contact Taj Pharma?
A20. Through the official Taj Pharma website or direct sales team.