GENERIC NAME OF THE MEDICINAL PRODUCT:
Fenofibrate Capsules USP 160mg
Fenofibrate Capsules USP 150mg
Fenofibrate Capsules USP 130mg
Fenofibrate Capsules USP 50mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each hard-gelatin capsule contains:
Fenofibrate…………………….200mg
Excipients………………………...……q.s.
Colour: Titanium Dioxide
b) Fenofibrate Capsules USP 160mg
Each hard-gelatin capsule contains:
Fenofibrate…………………………...160mg
Excipients………………………………….... q.s.
Colour: Iron Oxide Red
c) Fenofibrate Capsules USP 150mg
Each hard-gelatin capsule contains:
Fenofibrate……………………………150mg
Excipients……………………………….…...q.s.
Colour: Iron Oxide Yellow.
d) Fenofibrate Capsules USP 130mg
Each hard-gelatin capsule contains:
Fenofibrate…………………………...130mg
Excipients…………………………………... q.s.
Colour:Iron Oxide Black
e) Fenofibrate Capsules USP 50mg
Each hard-gelatin capsule contains:
Fenofibrate………………………...50mg
Excipients………………………………...q.s.
Colour: FD&C Blue (Indigo Carmine)
THERAPEUTIC INDICATIONS:
– Treatment of severe hypertriglyceridemia with or without low HDL cholesterol.
– Mixed hyperlipidemia when a statin is contraindicated or not tolerated.
– Mixed hyperlipidemia in patients at high cardiovascular risk in addition to a statin when triglycerides and HDL cholesterol are not adequately controlled.
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 Capsules Technical Specification:
| Product Name: | Fenofibrate Capsules USP |
| Brand Name: | FanaCor-Taj |
| Strength: | 50mg,130mg,150mg,160mg,200mg. |
| Dosage Form: | Capsule |
| Route of Administration: | Via oral route |
| Packing: | 30s,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. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Fenofibrate Capsules USP 200mg
- Fenofibrate Capsules USP 160mg
- Fenofibrate Capsules USP 150mg
- Fenofibrate Capsules USP 130mg
- Fenofibrate Capsules USP 50mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Fenofibrate Capsules USP 200mg
Each hard-gelatin capsule contains:
Fenofibrate………………………200mg
Excipients………………………………….q.s.
Colour: Titanium Dioxide
b) Fenofibrate Capsules USP 160mg
Each hard-gelatin capsule contains:
Fenofibrate……………………………160mg
Excipients……………………………………….q.s.
Colour: Iron Oxide Red
c) Fenofibrate Capsules USP 150mg
Each hard-gelatin capsule contains:
Fenofibrate………………………….150mg
Excipients………………………………………q.s.
Colour: Iron Oxide Yellow
d) Fenofibrate Capsules USP 130mg
Each hard-gelatin capsule contains:
Fenofibrate………………………….130mg
Excipients………………………………………q.s.
Colour: Iron Oxide Black
e) Fenofibrate Capsules USP 50mg
Each hard-gelatin capsule contains:
Fenofibrate…………………………..50mg
Excipients………………………………………q.s.
Colour: FD&C Blue (Indigo Carmine).
THERAPEUTIC INDICATIONS:
- Fenofibrate is indicated as an adjutant to diet and other non-pharmacological treatment (e.g., exercise, weight reduction) for the following:
– Treatment of severe hypertriglyceridemia with or without low HDL cholesterol.
– Mixed hyperlipidemia when a statin is contraindicated or not tolerated.
– Mixed hyperlipidemia in patients at high cardiovascular risk in addition to a statin when triglycerides and HDL cholesterol are not adequately con trolled.
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: Keep the container tightly closed in order to protect from moisture. Store in the original package. Do not store above 25°C.
- Dosage: As directed by the Physician.
Introduction to Fenofibrate Capsules 50mg
Fenofibrate Capsules 50mg are prescription oral medications primarily used to manage high cholesterol and triglyceride levels in the blood. By regulating lipid levels, they reduce the risk of cardiovascular diseases and prevent pancreatitis caused by elevated triglycerides.
Globally, hyperlipidemia and associated cardiovascular diseases are rising, creating a high demand for Fenofibrate Capsules 50mg in both developed and developing countries. These capsules are part of a comprehensive lipid-lowering therapy often recommended alongside lifestyle modifications, including diet and exercise.
Taj Pharma, a renowned Fenofibrate Capsules 50mg Manufacturer in India, ensures the production of high-quality, pure, and effective capsules that comply with international standards for domestic and export markets.
Therapeutic Uses and Clinical Significance
Fenofibrate 50mg Capsules help:
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Lower triglycerides and LDL (“bad”) cholesterol
-
Increase HDL (“good”) cholesterol
-
Reduce the risk of heart attack, stroke, and pancreatitis
Key Advantages of Fenofibrate Capsules 50mg
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Effective management of hyperlipidemia
-
Reduces cardiovascular risk factors
-
Safe and well-tolerated with minimal side effects when taken as prescribed
Taj Pharma provides capsules formulated with precision, ensuring consistent efficacy and safety for patients globally.
Trusted Manufacturer of Fenofibrate Capsules 50mg
Taj Pharma Ltd, based in Vapi, Gujarat, is a top Manufacturer, Exporter, and Supplier of Fenofibrate Capsules 50mg in India. Key highlights include:
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WHO-GMP certified production facilities
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Adherence to international pharmacopoeial standards
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Expertly formulated capsules for global markets
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Strict quality control and batch testing
With years of experience in API and finished dosage manufacturing, Taj Pharma has become a preferred choice for importers, distributors, and healthcare providers worldwide.
Dosage, Administration & Patient Guidance
-
Recommended Dose: As prescribed by the doctor; typically 50mg once daily
-
Administration: Can be taken with food to improve absorption
-
Patient Guidance:
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Maintain regular follow-ups and lipid profile tests
-
Continue prescribed diet and exercise plan
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Do not stop the medicine abruptly to avoid a rebound increase in cholesterol levels
-
Lifestyle Measures for Best Results
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Balanced diet low in saturated fats
-
Regular exercise
-
Weight management
-
Avoid smoking and limit alcohol consumption
Side Effects and Safety Information
Common Side Effects of Fenofibrate Capsules 50mg:
-
Nausea and vomiting
-
Abdominal pain and diarrhea
-
Back pain
-
Flatulence
-
Headache
-
Increased liver enzymes and creatine phosphokinase (CPK)
Precautions:
-
Avoid if you have severe kidney or liver disease
-
Consult your doctor before use if pregnant or breastfeeding
-
Inform your doctor of all current medications to prevent interactions
-
Most side effects are mild and resolve as the body adjusts
In-Depth Details for Importers, Exporters, and Buyers
Regulatory Documentation Provided
Taj Pharma offers complete documentation for seamless international trade:
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WHO-GMP certification
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EU-GMP certification (upon request)
-
Certificate of Pharmaceutical Product (COPP)
-
CTD/eCTD dossiers
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Certificate of Analysis (CoA)
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Stability and safety reports
Custom Packaging & Labeling
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Blister packs, HDPE bottles, and Alu-Alu packaging
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Multilingual labels as per regulatory requirements
-
Private labeling and PCD Pharma franchise options
Shelf-Life, Storage & Dosage Form
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Dosage Form: Capsules
-
Strength: 50mg
-
Shelf Life: 24–36 months
-
Storage: Store below 25°C; keep away from moisture and direct sunlight
Export Certifications & Target Markets
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WHO-GMP, EU-GMP, COPP, CTD Dossier
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Exported to countries across Africa, Middle East, Asia, Latin America, and CIS regions
Why Taj Pharma is the Most Trusted Manufacturer & Exporter
State-of-the-Art Manufacturing
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Automated production lines with strict quality control
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Advanced in-process testing ensures compliance with pharmacopoeial standards
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GMP-compliant production units
Affordable Pricing & Quality Assurance
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Competitive pricing without compromising quality
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Consistent batch-to-batch reliability for international orders
Global Presence & Supply Chain Support
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Timely shipments worldwide
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Full regulatory support for importers and distributors
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End-to-end logistics and warehousing support
Top 20 Export Countries
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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 Specification Product Name Fenofibrate Capsules Strength 50 mg Dosage Form Capsule Therapeutic Class Lipid-Lowering Agent Route of Administration Oral Shelf Life 24–36 Months Storage Below 25°C, dry place Packaging Blister / Bottle Certification WHO-GMP Manufacturer Taj Pharma Ltd, India
PAN India Manufacturer & PCD Pharma Franchise Opportunities
Taj Pharma offers:
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Fenofibrate Capsules 50mg PAN India Manufacturing
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PCD Pharma Franchise / Manufacturer and Supplier
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Best Price in Mumbai, Maharashtra – Taj Pharma
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Leading 1 Manufacturer & Supplier in India
Call to Action
For global buyers and distributors seeking a reliable Fenofibrate Capsules 50mg Manufacturer in India, Taj Pharma offers:
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WHO-GMP certified, high-quality capsules
-
Full regulatory support for smooth import
-
Bulk supply and private labeling options
-
PCD Pharma franchise opportunities
✅ Contact Taj Pharma today to secure your supply and partnership opportunities.
Top 20 FAQs
-
What is Fenofibrate 50mg used for?
To manage high cholesterol and triglycerides. -
Who is the leading manufacturer in India?
Taj Pharma. -
Is it WHO-GMP certified?
Yes. -
When should I take it?
With food at the same time daily. -
Shelf life of the capsule?
24–36 months. -
Can it cause side effects?
Mild nausea, abdominal pain, headache, or back pain. -
Is it safe for liver or kidney patients?
Consult your doctor first. -
Can it be used during pregnancy?
Only under medical guidance. -
Export documentation provided?
Yes, including COPP and CTD dossiers. -
Private labeling available?
Yes. -
Packaging types?
Blister packs, HDPE bottles. -
Target export markets?
Africa, Middle East, Asia, Latin America. -
EU-GMP certification available?
On request. -
Manufacturing location?
Vapi, Gujarat, India. -
Can it be taken with other medications?
Only under doctor supervision. -
PCD Pharma Franchise available?
Yes. -
Bulk supply possible?
Yes. -
Competitive pricing?
Yes. -
Technical product support available?
Yes. -
How to contact Taj Pharma?
Through official sales channels or website.
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