GENERIC NAME OF THE MEDICINAL PRODUCT:
Fenofibrate Tablet USP 48mg
Fenofibrate Tablet USP 54mg
Fenofibrate Tablet USP 120mg
Fenofibrate Tablet USP 160mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
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:
CAUTION & WARNING:
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:
Dosage: As directed by the Physician.
Attach dispensing label as per end county.
Fenofibrate Tablet 160mg Technical Specification:
| Product Name: |
Fenofibrate Tablet USP |
| Brand Name: | Generics |
| Strength: | 40 mg, 48 mg, 54 mg,120 mg, 160 mg |
| Dosage Form: | Tablets (Film coated) |
| Route of Administration: | Via oral Route |
| Packing: | 40s, 90s, 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: | Antilipemic agents, Antihyperlipidemic, Fibric acid agent. |
| Indication: | 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. |
| 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 |
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 Tablet 160mg
Fenofibrate Tablet 160mg is a widely prescribed lipid-modifying agent used in the treatment of hypercholesterolemia and hypertriglyceridemia—conditions where patients experience high levels of cholesterol and triglycerides in the bloodstream. This medication works effectively by reducing levels of low-density lipoprotein (LDL or “bad” cholesterol) and triglycerides while simultaneously increasing levels of high-density lipoprotein (HDL or “good” cholesterol). Clinically proven to reduce the risk of cardiovascular events such as heart attacks and strokes, Fenofibrate 160mg has become a vital therapeutic agent worldwide.
The demand for Fenofibrate Tablet 160mg is rapidly expanding across regions such as Africa, the Middle East, Latin America (LTAM), and Southeast Asia. As chronic lifestyle diseases such as diabetes and cardiovascular ailments surge globally, the role of cholesterol-regulating drugs like Fenofibrate becomes increasingly crucial. Taj Pharma has established itself as the top Fenofibrate Tablet 160mg manufacturer in India, offering this life-saving medication with superior quality, safety, and efficacy standards.
In-depth Details for Importers, Exporters, and Global Buyers
International pharmaceutical importers, distributors, and procurement agencies need reliability, quality compliance, and end-to-end export support. Taj Pharma, the Fenofibrate Tablet 160mg exporter from India, fulfills all these requirements with unmatched consistency.
Taj Pharma ensures the following for global buyers:
Regulatory Documentation Provided
Every batch of Fenofibrate Tablet 160mg comes with complete documentation, including the Certificate of Analysis (CoA), Stability Data, Certificate of Pharmaceutical Product (COPP), MSDS, and product quality dossier as per ICH/CTD format. These documents ensure smooth regulatory approvals and swift market entry in any country.
Custom Packaging and Private Labeling
Buyers can customize packaging as per market preferences—multi-lingual labels, customized carton design, tamper-evident blister or strip packaging, and leaflets tailored to national regulatory requirements are offered. Taj Pharma also offers white-label and third-party manufacturing services.
Shelf-Life, Storage & Dosage Form
Taj Pharma offers Fenofibrate Tablet 160mg in tablet form, typically packaged in Alu-Alu or Blister Packs with a shelf life of 24 to 36 months. Storage guidelines recommend keeping the medication in a cool, dry place below 30°C, away from light and moisture.
Export Certifications
Taj Pharma’s Fenofibrate Tablet 160mg is produced in a WHO-GMP, EU-GMP, and ISO 9001:2018 certified facility. Export-ready documentation includes:
-
WHO-GMP Certificate
-
EU-GMP and PIC/S compliance
-
COPP (Certificate of Pharmaceutical Product)
-
CTD Dossiers
-
Free Sale Certificates (FSC)
-
Stability reports (Zone IVa & IVb)
-
Bioequivalence and clinical data (if applicable)
Target Countries & Export Markets
Taj Pharma has earned significant market share in over 30 countries. Its Fenofibrate Tablet 160mg exports from India cover:
-
African nations (Nigeria, Kenya, Ghana, Tanzania)
-
Middle East (UAE, Saudi Arabia, Oman)
-
Latin America (Peru, Colombia, Ecuador)
-
CIS countries (Kazakhstan, Uzbekistan)
-
Southeast Asia (Vietnam, Philippines, Myanmar)
-
Caribbean markets and Pacific Islands
Why is Most Trusted Fenofibrate Tablet 160mg Manufacturer in India
Taj Pharma’s global recognition is the result of years of dedication to excellence, compliance, and affordability. Their position as the #1 Fenofibrate Tablet 160mg manufacturer and supplier in India is built on several pillars:
State-of-the-Art Manufacturing
Located in Vapi, Gujarat, Taj Pharma’s facility is equipped with advanced technologies like PLC-controlled systems, HEPA filters, and automated packaging lines. The production of Fenofibrate Tablet 160mg adheres strictly to cGMP and PIC/S standards, ensuring international quality benchmarks are met.
Affordable Pricing with Premium Quality
Taj Pharma delivers Fenofibrate Tablet 160mg at globally competitive prices without compromising quality. This is crucial for government tenders, hospital chains, NGOs, and large importers seeking high-efficacy medications at economical rates. Their transparent pricing structure makes them the preferred partner for long-term contracts and public-private partnerships.
Global Presence and Strong Supply Chain
With over two decades in pharmaceutical exports, Taj Pharma has an agile, responsive supply chain capable of handling urgent bulk requirements, tenders, and fast-track deliveries. The company operates through distribution partners, local agents, and licensing in various countries, reinforcing its global footprint.
Top 20 Countries Exporting Fenofibrate Tablet 160mg To:
Nigeria, Kenya, Uganda, Ethiopia, South Africa, Iraq, Afghanistan, Myanmar, Vietnam, Philippines, Peru, Chile, Ecuador, Sri Lanka, Bangladesh, Kazakhstan, Belarus, Uzbekistan, Sudan, Yemen
Technical Product Specification Table
| Specification | Details |
|---|---|
| Product Name | Fenofibrate Tablet 160mg |
| Strength | 160mg |
| Dosage Form | Oral Tablets |
| Packaging Options | Alu-Alu, Blister, Bottle Packs |
| Shelf Life | 24 to 36 Months |
| Therapeutic Use | Lipid-lowering agent, Cholesterol & Triglyceride Management |
| Storage Conditions | Store below 30°C in a dry, dark place |
| Available Certification | WHO-GMP, EU-GMP, COPP, CTD Dossier, ISO 9001:2018 |
| Manufacturing Location | Vapi, Gujarat, India |
| Manufacturer | Taj Pharma |
| Export Ready | Yes – Documentation Compliant for Global Markets |
📞 Contact Us Today
Partner with one of the most reliable pharmaceutical companies in India. For Fenofibrate Tablet 160mg 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
1. What is Fenofibrate Tablet 160mg used for?
It is used to lower bad cholesterol (LDL) and triglycerides while increasing good cholesterol (HDL), reducing cardiovascular risk.
2. Who manufactures the best Fenofibrate Tablet 160mg in India?
Taj Pharma is the leading Fenofibrate Tablet 160mg manufacturer in India, known for quality and compliance.
3. Is this tablet safe for long-term use?
Yes, under medical supervision, it is safe for chronic lipid disorders.
4. Can it affect kidney function?
It may cause slight changes in renal markers, especially in pre-existing conditions—monitoring is advised.
5. Is it suitable for diabetic patients?
Yes, especially for those with mixed dyslipidemia, but under doctor’s guidance.
6. What certifications does Taj Pharma offer for this product?
WHO-GMP, EU-GMP, COPP, CTD Dossiers, ISO 9001:2018.
7. What are the available pack sizes?
Commonly available in blister and Alu-Alu packs of 10, 30, or 100 tablets.
8. Can I get private labeling?
Yes, Taj Pharma provides white-label and custom branding.
9. How should it be stored?
Store below 30°C in a dry, dark place.
10. Is bioequivalence data available?
Yes, it can be provided upon request.
11. Can Taj Pharma supply to government tenders?
Absolutely. They are compliant with institutional procurement norms.
12. Is Fenofibrate Tablet 160mg suitable for heart disease prevention?
Yes, by managing lipid profiles effectively.
13. What is the shelf life of the product?
Typically 2–3 years depending on packaging.
14. Are there any side effects?
Mild gastrointestinal discomfort or muscle pain in some cases.
15. Can I import this tablet to Africa/Middle East?
Yes, it is already exported widely to these regions.
16. How soon can large orders be delivered?
Usually within 2–4 weeks depending on the volume.
17. Does Taj Pharma support regulatory filings?
Yes, they provide full CTD dossiers and support.
18. What are the dosage guidelines?
One 160mg tablet daily, preferably with food, or as directed by a physician.
19. Is it WHO-GMP approved?
Yes, Taj Pharma’s plant is WHO-GMP certified.
20. How to initiate bulk order discussion?
Contact Taj Pharma’s export desk directly via email or WhatsApp.






