Rosuvastatin+Ezetimibe Tablet 5mg+10mg

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

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Rosuvastatin+Ezetimibe Tablet IP 5mg+10mg
• Rosuvastatin+Ezetimibe Tablet IP 10mg+10mg
• Rosuvastatin+Ezetimibe Tablet IP 20mg+10mg
• Rosuvastatin+Ezetimibe Tablet IP40mg+10mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• a) Rosuvastatin+Ezetimibe Tablet IP 5mg+10mg
  Each Film coated Tablet contains:
  Rosuvastin Calcium IP
  Eq. to Rosuvastin…………………5mg
  Ezetimibe IP……………………10mg
  Excipients…………………………. Q.s.
  Colours: Ferric Oxide (RED)
•  b) Rosuvastatin+Ezetimibe Tablet IP 10mg+10mg
  Each Film coated Tablet contains:
  Rosuvastin Calcium IP
  Eq. to Rosuvastin…………………10mg
  Ezetimibe IP……………………10mg
  Excipients…………………………. Q.s.
  Colours: Pigment yellow 3
• c) Rosuvastatin+Ezetimibe Tablet  IP 20mg+10mg
  Each Film coated Tablet contains:
  Rosuvastin Calcium IP
  Eq. to Rosuvastin…………………20mg
  Ezetimibe IP……………………10mg
  Excipients…………………………. Q.s.
  Colours: Red oxide of iron
• d) Rosuvastatin+Ezetimibe Tablet IP 40mg+10mg
  Each Film coated Tablet contains:
  Rosuvastin Calcium IP
  Eq. to Rosuvastin…………………40mg
  Ezetimibe IP……………………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

STORAGE & DOSAGE:

• Storage:Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. 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 powerful combination medication used for lowering high cholesterol levels in patients at risk of cardiovascular diseases. This pharmaceutical formulation combines Rosuvastatin, a statin that inhibits the HMG-CoA reductase enzyme to reduce cholesterol synthesis in the liver, and Ezetimibe, a cholesterol absorption inhibitor that blocks intestinal uptake of cholesterol.

This dual-action therapy is widely preferred globally for its superior efficacy in reducing LDL (bad) cholesterol, total cholesterol, and triglycerides, while modestly increasing HDL (good) cholesterol.

The growing global demand for Rosuvastatin+Ezetimibe 5mg+10mg has opened doors for high-quality, compliant manufacturers in India—Taj Pharma being the most trusted among them.

Key Uses of Rosuvastatin+Ezetimibe Tablet 5mg+10mg:

• Hypercholesterolemia (high cholesterol)

• Mixed dyslipidemia

• Cardiovascular risk management

• Familial hypercholesterolemia

This tablet is a cornerstone in preventive cardiology, particularly for patients who require additional LDL lowering beyond statin monotherapy.

Comprehensive Details for Importers, Exporters & Buyers

✅ Regulatory Documentation Provided by Taj Pharma

As a WHO-GMP certified manufacturer, Taj Pharma provides comprehensive regulatory support to global buyers, including:

• Certificate of Pharmaceutical Product (COPP)

• WHO-GMP, EU-GMP Compliance

• USFDA readiness & MHRA aligned protocols

• CTD/ACTD Dossier support

• Site Master File & Stability Data

• Free Sale Certificate

• Audit Reports & Batch Manufacturing Records (BMR)

✅ Custom Packaging & Private Labeling Services

Taj Pharma provides international clients with:

• Tailored branding, artwork, and logo placement

• Multi-language labeling & barcoding

• Tamper-proof and eco-friendly packaging

• Blister, strip, alu-alu, and bottle formats

✅ Shelf Life, Storage & Dosage Form

• Shelf-life: 24 to 36 months (customized per market)

• Storage: Store below 30°C; protect from moisture

• Dosage Form: Oral tablet (film-coated)

✅ Certifications & Export Authorizations

• WHO-GMP certified

• EU-GMP (on request)

• ISO 9001:2015 & ISO 14001:2015

• COA, MSDS, MOA with each batch

• DMF on request

• Third-Party & Contract Manufacturing Options

✅ Global Export Markets for Rosuvastatin+Ezetimibe Tablet 5mg+10mg

Taj Pharma exports across regulated and semi-regulated markets such as:

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

• Asia: Vietnam, Philippines, Thailand, Sri Lanka

• Middle East: UAE, Saudi Arabia, Iraq, Jordan

• Latin America: Peru, Bolivia, Mexico, Colombia

• CIS & Europe: Ukraine, Georgia, Armenia, Romania

Why is it the Most Trusted Rosuvastatin+Ezetimibe Tablet 5mg+10mg Manufacturer in India

🌟 State-of-the-Art Manufacturing Facility

Taj Pharma operates EU-GMP and WHO-GMP approved manufacturing plants in Vapi, Gujarat, with:

• Automated production lines

• Air-controlled & contamination-free zones

• In-house R&D and analytical testing labs

• cGMP, ICH, and Schedule M compliance

🌟 Unmatched Quality Assurance

Every batch undergoes:

• Strict in-process QC checks

• Analytical method validation

• Stability studies

• HPLC purity profiling and bioavailability analysis

🌟 Affordable Global Pricing with No Compromise on Quality

Taj Pharma ensures:

• Cost-effective pricing with bulk production capacity

• Competitive FOB and CIF rates

• Zero tolerance for substandard raw materials

🌟 Global Presence & Strong Export Network

• Over 80 countries covered

• Active PCD Pharma Franchise network

• Dedicated regulatory & logistics team

• Seamless end-to-end supply chain management

Technical Product Specification 

Top 20 Export Destinations for Rosuvastatin+Ezetimibe Tablet 5mg+10mg from Taj Pharma

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

Are you looking for a reliable, WHO-GMP certified manufacturer of Rosuvastatin+Ezetimibe Tablet 5mg+10mg in India? Taj Pharma offers:

• Full regulatory documentation

• Consistent global supply chain

• Competitive pricing for large volume orders

📩 Contact us now for:

• Export inquiries

• PCD franchise opportunities

• Third-party manufacturing

Email: info@tajpharma.com
Phone: +91-22-26374592
Website: www.tajpharma.com

Top 20 FAQs 

1. What is Rosuvastatin+Ezetimibe Tablet 5mg+10mg used for?
It is used to lower high cholesterol and prevent cardiovascular events.

2. How does the combination work?
Rosuvastatin reduces liver cholesterol production, while Ezetimibe reduces absorption in the gut.

3. Is it a prescription medicine?
Yes, it should only be taken under medical supervision.

4. What are the side effects?
Common ones include headache, nausea, fatigue, and muscle pain.

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

6. Is it suitable for long-term use?
Yes, under regular monitoring by your healthcare provider.

7. Who should not take this medication?
Pregnant women, lactating mothers, and patients with liver disease.

8. What certifications does Taj Pharma hold?
WHO-GMP, ISO 9001:2015, COPP, CTD Dossiers, and more.

9. Does Taj Pharma offer private labeling?
Yes, complete custom branding is available.

10. Can Taj Pharma ship globally?
Yes, to 80+ countries.

11. What is the MOQ for exports?
Typically 1,00,000 tablets or as per client needs.

12. Are stability studies available?
Yes, accelerated and real-time data are provided.

13. What dosage forms are available?
Oral film-coated tablets.

14. Can Taj Pharma support tenders?
Yes, with full documentation and volume pricing.

15. How is quality ensured?
Through in-house QC labs, validations, and audits.

16. What is the lead time for production?
Around 15–30 days.

17. Do you provide Dossiers?
Yes, CTD and ACTD format dossiers are available.

18. Is it possible to get free samples?
Upon commercial agreement and documentation.

19. Are your products registered globally?
Yes, across several health authorities.

20. Do you offer third-party manufacturing?
Yes, with complete tech transfer support.