Rosuvastatin+Ezetimibe Tablet 5mg+10mg

Rosuvastatin+Ezetimibe Tablet 5mg+10mg Technical Specification:

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 5mg+10mg

Rosuvastatin+Ezetimibe Tablet 5mg+10mg is a fixed-dose combination drug widely prescribed to patients with hypercholesterolemia (high cholesterol) and those at risk of cardiovascular disease (CVD).

• Rosuvastatin (5mg): A statin that blocks the HMG-CoA reductase enzyme in the liver, reducing cholesterol production and lowering LDL (“bad cholesterol”).

• Ezetimibe (10mg): A selective cholesterol absorption inhibitor that reduces intestinal absorption of dietary cholesterol.

When combined, these agents provide synergistic lipid-lowering effects, reducing cardiovascular risk factors and preventing complications such as heart attack, atherosclerosis, and stroke.

Global demand for Rosuvastatin+Ezetimibe Tablet 5mg+10mg continues to rise due to the increasing prevalence of obesity, sedentary lifestyles, and rising cardiovascular disease incidence. For international buyers, sourcing from a trusted Indian manufacturer like Taj Pharma ensures access to WHO-GMP-certified, cost-effective, and globally compliant products.

In-Depth Details for Importers, Exporters, and Buyers

1. Regulatory Documentation Provided

Taj Pharma provides complete regulatory support to international buyers, ensuring easy registration in both regulated and semi-regulated markets. Documentation includes:

• WHO-GMP Certificate

• EU-GMP Compliance Certificate

• Certificate of Pharmaceutical Product (COPP)

• CTD/ACTD Dossier

• Certificate of Analysis (COA)

• Stability data (Zone III & IV)

• Free Sale Certificate

• Manufacturing License & Product Registration Dossier

2. Custom Packaging & Labeling

Taj Pharma specializes in export-ready packaging solutions, such as:

• Blister packs, bottles, or bulk packs

• Country-specific artwork for regulatory compliance

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

• Tamper-proof and export-compliant packaging

3. Shelf-Life, Storage, and Dosage Form

• Dosage Form: Film-coated tablets

• Strength: Rosuvastatin 5mg + Ezetimibe 10mg

• Shelf Life: 24–36 months (as per ICH guidelines)

• Storage: Store in a cool, dry place below 25°C, away from sunlight and moisture

4. Export Certifications

Taj Pharma holds multiple certifications that ensure compliance and global acceptance:

• WHO-GMP certification

• EU-GMP certification

• ISO 9001:2015

• COPP (Certificate of Pharmaceutical Product)

• MOH registrations across Asia, Africa, and Latin America

5. Target Countries & Export Markets

Taj Pharma exports Rosuvastatin+Ezetimibe Tablet 5mg+10mg to 40+ countries, including:

• Africa: Nigeria, Kenya, South Africa, Ghana, Tanzania

• Asia: Vietnam, Philippines, Sri Lanka, Nepal, Myanmar

• CIS: Kazakhstan, Uzbekistan, Ukraine

• Middle East: UAE, Iraq, Oman, Saudi Arabia, Yemen

• Europe & Americas: UK, Canada, Latin America

Why is the Most Trusted Manufacturer & Supplier

As one of India’s leading pharmaceutical exporters, Taj Pharma has earned the trust of global buyers, distributors, and healthcare providers.

1. State-of-the-Art Manufacturing

• WHO-GMP & EU-GMP certified plant located in Vapi, Gujarat

• Advanced quality control labs with HPLC, UV, and stability chambers

• Strict adherence to IP, BP, USP pharmacopoeial standards

2. Affordable Pricing & Quality Assurance

• Competitive bulk pricing for Rosuvastatin+Ezetimibe Tablet 5mg+10mg export from India

• Each batch tested for purity, potency, and stability

• Zero-compromise policy on international regulatory compliance

3. Global Presence & Supply Chain Support

• Established supply networks in 40+ countries

• On-time deliveries with temperature-controlled logistics

• Regulatory support for NGOs, tenders, and government procurement

4. Top 20 Export Destinations

Nigeria, Kenya, Ghana, Iraq, UAE, Saudi Arabia, Bangladesh, Sri Lanka, Vietnam, Ukraine, Uzbekistan, Colombia, Peru, Ecuador, Philippines, Tanzania, Myanmar, Cambodia, Jordan, Zambia

Technical Product Specification Table

Call to Action

Looking for a reliable Rosuvastatin+Ezetimibe Tablet 5mg+10mg manufacturer in India?

👉 Partner with Taj Pharma, the trusted name in global pharmaceutical exports.

📞 Contact us today for bulk orders, tenders, and PCD Pharma Franchise opportunities.

🌐 Visit www.tajpharma.com for product details and regulatory support.

Top 20 FAQs

1. What is Rosuvastatin+Ezetimibe Tablet 5mg+10mg used for?
It lowers cholesterol and prevents cardiovascular diseases.

2. Who is the best manufacturer in India?
Taj Pharma, a WHO-GMP-certified company in Vapi, Gujarat.

3. How does it work?
Rosuvastatin reduces liver cholesterol production, while Ezetimibe blocks absorption in the intestines.

4. Can it be taken with food?
Yes, it can be taken with or without meals.

5. What are common side effects?
Muscle pain, fatigue, nausea, headache, diarrhea, back pain.

6. Is it suitable for long-term therapy?
Yes, under medical supervision with regular lipid profile checks.

7. What certifications does Taj Pharma provide?
WHO-GMP, EU-GMP, COPP, ISO 9001:2015.

8. Is it available for export?
Yes, Taj Pharma exports to over 40 countries.

9. Can packaging be customized?
Yes, with multilingual labels and country-specific artwork.

10. What is its shelf life?
24 to 36 months.

11. Does Taj Pharma offer bulk supply?
Yes, for distributors and government tenders.

12. Which pharmacopoeias does it follow?
IP, BP, and USP standards.

13. Does Taj Pharma supply NGOs and tenders?
Yes, with complete regulatory support.

14. Can it be used to prevent stroke?
Yes, it helps reduce stroke and heart attack risks.

15. Does Taj Pharma offer PCD Pharma Franchise?
Yes, across PAN India.

16. Is it exported to regulated markets?
Yes, including the UK, Canada, and Europe.

17. What is the dosage strength?
Rosuvastatin 5mg + Ezetimibe 10mg.

18. How should it be stored?
At room temperature, below 25°C, protected from moisture.

19. Why Taj Pharma?
Because of its global credibility, affordability, and WHO-GMP certification.

20. How to import it?
Buyers can contact Taj Pharma for regulatory documents and export support.