GENERIC NAME OF THE MEDICINAL PRODUCT:
b) Choline Fenofibrate DR Capsule 135mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each delayed release tablet contains:
Choline Fenofibrate
Equivalent to Fenofibrate acid…………45mg
Excipients……………………………. q.s.
Colours: Ferric Oxide Yellow USP-NF
b) Choline Fenofibrate DR Capsule 135mg
Each delayed release tablet contains:
Choline Fenofibrate
Equivalent to Fenofibrate acid…………135mg
Excipients……………………………. q.s.
Colours: Titanium Dioxide IP
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.
Choline Fenofibrate DR Capsules 45mg Technical Specification:
| Product Name: | Choline Fenofibrate DR Capsule |
| Brand Name: | Generics |
| Strength: | (45mg), (135mg) |
| Dosage Form: | Capsule (Hard-Gelatine) |
| Route of Administration: | Via oral Route |
| Packing: | 90s, 100s, 500s, 1000s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antihyperlipidemic, Cardio vascular |
| Indication: | Feno fibric acid 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. It works by increasing the natural substance (enzyme) that breaks down fats in the blood. |
| Storage: | Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Choline Fenofibrate DR Capsule 45mg
- Choline Fenofibrate DR Capsule 135mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Choline Fenofibrate DR Capsule 45mg
Each delayed release tablet contains:
Choline Fenofibrate
Equivalent to Fenofibrate acid…………45mg
Excipients……………………………. q.s.
Colours: Ferric Oxide Yellow USP-NF - Choline Fenofibrate DR Capsule 135mg
Each delayed release tablet contains:
Choline Fenofibrate
Equivalent to Fenofibrate acid…………135mg
Excipients……………………………. q.s.
Colours: Titanium Dioxide IP
THERAPEUTIC INDICATIONS:
- Fenofibric acid 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. It works by increasing the natural substance (enzyme) that breaks down fats 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: Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect from moisture.
- Dosage: As directed by the Physician.
Introduction to Choline Fenofibrate DR Capsules 45mg
Choline Fenofibrate DR Capsules 45mg is a powerful lipid-regulating medication prescribed primarily to treat hyperlipidemia, including high cholesterol (hypercholesterolemia) and elevated triglyceride levels (hypertriglyceridemia). It is a derivative of fenofibric acid that offers enhanced solubility, better bioavailability, and improved patient compliance. As a drug of choice for patients who are either intolerant to statins or require combination therapy, it plays a pivotal role in managing dyslipidemia and reducing the risk of cardiovascular diseases. With the increasing prevalence of lifestyle-related disorders and cardiovascular risks, the global demand for Choline Fenofibrate DR Capsules 45mg continues to surge, especially in countries with aging populations and rising obesity rates.
The unique delayed-release (DR) formulation ensures optimal absorption in the intestine, minimizing gastrointestinal side effects while maintaining efficacy. This innovative product has gained popularity among cardiologists and general practitioners worldwide, making it a sought-after item for pharmaceutical importers, hospitals, and healthcare distributors across Asia, Africa, Latin America, and Europe.
Details for Importers, Exporters & Global Buyers
Taj Pharma ensures that international buyers receive Choline Fenofibrate DR Capsules 45mg with complete regulatory support. Buyers are provided with detailed documentation including Certificate of Pharmaceutical Product (CoPP), WHO-GMP certifications, CTD/ACTD Dossiers, Stability Studies, and Batch Manufacturing Records. The company offers customization for secondary packaging and labeling as per the importing country’s regulatory norms, enabling ease of product registration and market entry.
The capsules are usually supplied in 10×10 blister or alu-alu packs, securely packed in export-worthy cartons. Each shipment includes multi-language inserts if required, enhancing accessibility for non-English speaking regions.
Shelf-life for the Choline Fenofibrate DR Capsules 45mg is generally 36 months under recommended storage conditions (below 25°C, protected from moisture). Dosage form is oral, taken once daily with food for better bioavailability.
As a WHO-GMP certified manufacturer in India, Taj Pharma also complies with stringent EU-GMP, US-FDA, and other country-specific GMP norms. Products are registered and exported to regulated markets like South Africa, Vietnam, Kenya, Myanmar, the Philippines, Colombia, Nigeria, and Cambodia, among others.
Why Taj Pharma is the Most Trusted Choline Fenofibrate DR Capsules 45mg Manufacturer in India
Taj Pharma India, based in Vapi, Gujarat, is a pharmaceutical powerhouse recognized globally for producing high-purity cardiovascular and metabolic disorder medications. As a leading Choline Fenofibrate DR Capsules 45mg Manufacturer in India, the company is trusted for its consistent product quality, advanced formulations, and regulatory compliance.
With state-of-the-art cGMP-certified facilities and highly automated lines, Taj Pharma delivers bulk quantities with assured quality. Its world-class R&D division ensures innovation in formulations, including sustained-release, delayed-release, and combination therapies for lipid control.
Taj Pharma offers highly competitive pricing, which makes it an ideal partner for government tenders, hospitals, PCD franchises, and pharmaceutical importers in both regulated and semi-regulated markets. Its reliable cold-chain logistics and export support team make international transactions smooth and timely.
The company exports Choline Fenofibrate DR Capsules 45mg to over 30 countries globally, including Nigeria, Vietnam, Kenya, Mozambique, Iraq, Afghanistan, South Africa, Ghana, Cambodia, Bangladesh, Ukraine, Peru, and Ecuador. It is listed among the Top 10 exporters of cardiovascular drugs from India, and it continues to expand its footprint through exclusive distribution partnerships.
Technical Specifications
| Product Name | Choline Fenofibrate DR Capsules 45mg |
|---|---|
| Dosage Form | Delayed-Release Capsules |
| Strength | 45mg |
| Active Ingredient | Choline Fenofibrate |
| Therapeutic Category | Antihyperlipidemic / Lipid-lowering agent |
| Packaging Type | Alu-Alu / Blister Pack, 10×10 capsules |
| Shelf Life | 36 months |
| Route of Administration | Oral |
| Recommended Dosage | Once daily with food |
| Storage Conditions | Store below 25°C, protect from moisture |
| Certifications Available | WHO-GMP, EU-GMP, CoPP, CTD Dossier, FSC |
| Manufacturer Location | Taj Pharmaceuticals Ltd., Vapi, Gujarat, India |
📞 If you’re seeking a reliable Choline Fenofibrate DR Capsules 45mg Manufacturer and Supplier in India, look no further than Taj Pharma. We offer regulatory-ready, export-compliant formulations at unbeatable prices with guaranteed quality. Whether you’re a government agency, hospital, pharma distributor, or importer, our logistics and documentation support will streamline your procurement process.
📧 Email: info@tajpharma.com
📱 Phone: +91 84484 44095
📲 WhatsApp: +91 7400009975 / +91 7400009976
🌐 Website: www.tajpharmaindia.com
Top 20 FAQs
1. What is Choline Fenofibrate DR Capsules 45mg used for?
It’s used to lower cholesterol and triglyceride levels in patients with dyslipidemia and to prevent cardiovascular complications.
2. Is Taj Pharma WHO-GMP certified?
Yes, Taj Pharma is a WHO-GMP-certified pharmaceutical manufacturer in India.
3. What makes Choline Fenofibrate different from standard fenofibrate?
Choline Fenofibrate has better water solubility and bioavailability, improving treatment outcomes.
4. How often should the capsule be taken?
Usually once daily, preferably with a meal for better absorption.
5. Can I take it with other cholesterol medications?
Yes, but if combined with bile acid resins, take it at least 1 hour before or 4-6 hours after them.
6. What certifications does Taj Pharma provide for exports?
WHO-GMP, CoPP, EU-GMP, CTD Dossier, FSC, and Stability data.
7. How is the shelf life of the product?
Generally, the shelf life is 36 months from the date of manufacture.
8. Can you customize packaging for international clients?
Yes, Taj Pharma offers country-specific packaging and labeling.
9. Which countries import Choline Fenofibrate DR Capsules 45mg from Taj Pharma?
Countries include South Africa, Kenya, Iraq, Vietnam, Nigeria, Bangladesh, Cambodia, and others.
10. Is there a PCD Pharma Franchise option available?
Yes, Taj Pharma offers PCD franchise opportunities PAN India.
11. How can international buyers place an order?
You can contact Taj Pharma via email or WhatsApp for export inquiries and documentation.
12. Are samples available for registration?
Yes, Taj Pharma provides product samples and dossiers for registration purposes.
13. Is the product suitable for long-term use?
Yes, it’s often prescribed for long-term lipid control under medical supervision.
14. Can this product be used alone or with statins?
It can be used both as monotherapy and in combination with statins.
15. What are the side effects?
Mild side effects include nausea, headache, or stomach upset. Serious side effects are rare.
16. Does Taj Pharma have a presence in regulated markets?
Yes, Taj Pharma supplies to both regulated and semi-regulated markets globally.
17. What is the manufacturing capacity?
Taj Pharma can handle high-volume batch manufacturing with global dispatch capabilities.
18. How is the product shipped internationally?
Via air or sea freight with temperature-controlled packaging if needed.
19. Do you assist with product registration in importing countries?
Yes, full regulatory support and documents are provided.
20. Why should I choose Taj Pharma over other manufacturers?
Due to its commitment to quality, affordability, fast delivery, and international regulatory expertise.
With rising global cardiovascular risk, sourcing the right pharmaceutical partner becomes critical. As a top Choline Fenofibrate DR Capsules 45mg Manufacturer in India, Taj Pharma offers unmatched quality, full regulatory documentation, and global distribution. Whether you’re in Africa, Latin America, or Southeast Asia, Taj Pharma is your trusted pharma export partner for cardiovascular medications.






