GENERIC NAME OF THE MEDICINAL PRODUCT:
Rosuvastatin+Ezetimibe Tablet 10mg+10mg
Rosuvastatin+Ezetimibe Tablet 20mg+10mg
Rosuvastatin+Ezetimibe Tablet 40mg+10mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each Film coated Tablet contains:
Rosuvastin Calcium
Eq. to Rosuvastin…………………5mg
Ezetimibe……………………10mg
Excipients…………………………. Q.s.
Colours: Ferric Oxide (RED)
b) Rosuvastatin+Ezetimibe Tablet 10mg+10mg
Each Film coated Tablet contains:
Rosuvastin Calcium
Eq. to Rosuvastin…………………10mg
Ezetimibe……………………10mg
Excipients…………………………. Q.s.
Colours: Pigment yellow 3
c) Rosuvastatin+Ezetimibe Tablet 20mg+10mg
Each Film coated Tablet contains:
Rosuvastin Calcium
Eq. to Rosuvastin…………………20mg
Ezetimibe……………………10mg
Excipients…………………………. Q.s.
Colours: Red oxide of iron
d) Rosuvastatin+Ezetimibe Tablet 40mg+10mg
Each Film coated Tablet contains:
Rosuvastin Calcium
Eq. to Rosuvastin…………………40mg
Ezetimibe……………………10mg
Excipients…………………………. Q.s.
Colours: Ponceau 4 R
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.
Rosuvastatin+Ezetimibe Tablet 40mg+10mg Technical Specification:
| Product Name: |
Rosuvastatin+Ezetimibe Tablet |
| Brand Name: | Generics |
| Strength: | (5mg+10mg), (10mg+10mg), (20mg+10mg), (40mg+10mg) |
| 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: | Antihyperlipidemic, Cardiology |
| Indication: | Rosuvastatin and ezetimibe combination is used together with a proper diet to lower bad cholesterol (LDL) in the blood. It is also used alone or together with other medicines to treat homozygous familial hypercholesterolemia (HoFH). |
| 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:
- Rosuvastatin+Ezetimibe Tablet 5mg+10mg
- Rosuvastatin+Ezetimibe Tablet 10mg+10mg
- Rosuvastatin+Ezetimibe Tablet 20mg+10mg
- Rosuvastatin+Ezetimibe Tablet 40mg+10mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- a) Rosuvastatin+Ezetimibe Tablet 5mg+10mg
Each Film coated Tablet contains:
Rosuvastin Calcium
Eq. to Rosuvastin…………………5mg
Ezetimibe……………………10mg
Excipients…………………………. Q.s.
Colours: Ferric Oxide (RED) - b) Rosuvastatin+Ezetimibe Tablet 10mg+10mg
Each Film coated Tablet contains:
Rosuvastin Calcium
Eq. to Rosuvastin…………………10mg
Ezetimibe……………………10mg
Excipients…………………………. Q.s.
Colours: Pigment yellow 3 - c) Rosuvastatin+Ezetimibe Tablet 20mg+10mg
Each Film coated Tablet contains:
Rosuvastin Calcium
Eq. to Rosuvastin…………………20mg
Ezetimibe……………………10mg
Excipients…………………………. Q.s.
Colours: Red oxide of iron - d) Rosuvastatin+Ezetimibe Tablet 40mg+10mg
Each Film coated Tablet contains:
Rosuvastin Calcium
Eq. to Rosuvastin…………………40mg
Ezetimibe……………………10mg
Excipients…………………………. Q.s.
Colours: Ponceau 4 R
THERAPEUTIC INDICATIONS:
- Rosuvastatin and ezetimibe combination is used together with a proper diet to lower bad cholesterol (LDL) in the blood. It is also used alone or together with other medicines to treat homozygous familial hypercholesterolemia (HoFH).
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 Rosuvastatin+Ezetimibe Tablet 40mg+10mg
Rosuvastatin+Ezetimibe Tablet 40mg+10mg is a fixed-dose combination designed to help patients achieve optimal cholesterol management when single-drug therapy is not sufficient. It combines:
-
Rosuvastatin (40mg): A potent statin that lowers cholesterol by inhibiting the HMG-CoA reductase enzyme in the liver, effectively reducing LDL (“bad cholesterol”).
-
Ezetimibe (10mg): Works in the intestine by blocking cholesterol absorption from food, complementing the action of rosuvastatin.
Together, this combination significantly reduces LDL cholesterol, total cholesterol, ApoB, and triglycerides, while increasing HDL (“good cholesterol”), thereby lowering the risk of atherosclerosis, heart attack, and stroke.
Globally, the prevalence of hypercholesterolemia and cardiovascular disease continues to rise, driving the demand for Rosuvastatin+Ezetimibe 40mg+10mg tablets. As a leading pharma hub, India is the preferred source for high-quality generic formulations. Among the top companies, Taj Pharma stands out as the most trusted Rosuvastatin+Ezetimibe Tablet 40mg+10mg manufacturer in India with proven excellence in exports and global partnerships.
Rosuvastatin+Ezetimibe Tablet 40mg+10mg for Importers, Exporters, and Buyers
International buyers, distributors, and government procurement agencies require certified medicines with complete regulatory documentation. Taj Pharma provides end-to-end export support.
1. Regulatory Documentation Provided
Taj Pharma supplies comprehensive documentation to ensure smooth international registrations:
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WHO-GMP / EU-GMP certifications
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Certificate of Pharmaceutical Product (COPP)
-
CTD/ACTD dossiers
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Certificate of Analysis (CoA)
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Stability data (Zone II–IV)
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Free Sales Certificate
2. Custom Packaging & Labeling
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Offered in blister packs, alu-alu strips, or bottles
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Private labeling for distributors & PCD Pharma franchise
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Packaging compliant with USFDA, EMA, TGA, and other authority standards
3. Shelf-Life, Storage & Dosage Form
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Shelf life: 24–36 months
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Storage: Cool, dry place below 25°C
-
Dosage form: Film-coated tablet (40mg + 10mg)
4. Export Certifications
Taj Pharma holds multiple global certifications, including:
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WHO-GMP
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EU-GMP
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ISO 9001:2015
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COPP & FSC approvals
5. Target Countries & Export Markets
Taj Pharma exports to 50+ countries, including:
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USA, UK, Germany, France, Italy, Spain
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UAE, Saudi Arabia, Oman, Qatar
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South Africa, Nigeria, Kenya, Egypt
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Vietnam, Philippines, Malaysia, Thailand
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Brazil, Chile, Colombia, Peru
Why is the Most Trusted Manufacturer, Supplier & Exporter
As a pioneer in pharmaceutical manufacturing and global supply, Taj Pharma is the preferred partner for Rosuvastatin+Ezetimibe Tablet 40mg+10mg exports from India.
1. State-of-the-Art Manufacturing
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Ultra-modern facilities in Vapi, Gujarat
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WHO-GMP and EU-GMP certified plants
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Dedicated R&D team for advanced formulations
2. Affordable Pricing & Quality Assurance
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Competitive pricing for bulk buyers
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Strict adherence to Good Manufacturing Practices (GMP)
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Batch-to-batch consistency ensured
3. Global Presence & Supply Chain Strength
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Established distribution across Asia, Africa, Europe, Middle East, and Latin America
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Bulk production capability to meet international tenders
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Fast and reliable logistics support
4. Top 20 Export Countries for Rosuvastatin+Ezetimibe Tablet 40mg+10mg
Nigeria, Kenya, South Africa, Vietnam, Philippines, Iraq, Libya, Uzbekistan, Ghana, Ethiopia, Yemen, Tanzania, Sri Lanka, Afghanistan, Myanmar, Nepal, Kazakhstan, Ecuador, Bangladesh, Dominican Republic
Technical Product Specification:
| Parameter | Details |
|---|---|
| Product Name | Rosuvastatin+Ezetimibe Tablet |
| Strength | 40mg + 10mg |
| Dosage Form | Film-coated tablet |
| Therapeutic Class | Lipid-lowering agent |
| Indication | Hypercholesterolemia, Cardiovascular risk reduction |
| Packaging | Blister packs, Alu-Alu strips, Bottles |
| Shelf Life | 24–36 months |
| Manufacturer | Taj Pharma Ltd, Vapi, Gujarat, India |
| Certifications | WHO-GMP, EU-GMP, ISO, COPP |
Looking for a reliable Rosuvastatin+Ezetimibe Tablet 40mg+10mg manufacturer in India?
Taj Pharma offers bulk exports, PCD Pharma franchise opportunities, and custom labeling services. With a strong global reputation, Taj Pharma ensures quality, affordability, and timely supply for every partner.
📩 Email: [info@tajpharma.com]
🌐 Website: www.tajpharma.com
Top 20 FAQs
1. What is Rosuvastatin+Ezetimibe Tablet 40mg+10mg used for?
It is prescribed to lower cholesterol and reduce the risk of heart disease.
2. Is Taj Pharma a certified manufacturer?
Yes, Taj Pharma is WHO-GMP and EU-GMP certified.
3. Can this medicine be taken with food?
Yes, it can be taken with or without food.
4. What are the common side effects?
Muscle pain, headache, diarrhea, nausea, and fatigue.
5. How long does it take to show results?
Several weeks of consistent use may be required.
6. Does Taj Pharma provide export documentation?
Yes, including COPP, CTD dossier, and CoA.
7. Can this tablet be used in children?
It is generally prescribed for adults only.
8. What is the shelf-life of the product?
24–36 months.
9. What packaging formats are available?
Blister packs, alu-alu strips, bottles.
10. Can pregnant women take it?
Not recommended unless specifically prescribed.
11. Is it available for bulk supply?
Yes, Taj Pharma supplies to global buyers and distributors.
12. Can it be combined with other cholesterol medicines?
Only under a doctor’s supervision.
13. What is the storage condition?
Store below 25°C, in a dry place.
14. Does Taj Pharma export to Africa?
Yes, including Nigeria, Kenya, South Africa, and Egypt.
15. Is it safe for long-term use?
Yes, under regular medical monitoring.
16. Can it cause muscle pain?
Yes, muscle pain or weakness may occur. Notify your doctor.
17. Why choose Taj Pharma?
For affordable, certified, and globally compliant medicines.
18. Where is Taj Pharma located?
In Vapi, Gujarat, India.
19. Does Taj Pharma offer PCD Pharma Franchise?
Yes, across PAN India.
20. What makes Taj Pharma unique?
Its global presence, WHO-GMP compliance, and trust of international buyers.






