Rosuvastatin Calcium Tablets 5mg (Rosutaj)

Rosuvastatin Calcium Tablets  5mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Rosuvastatin Calcium Tablets IP 5mg
• Rosuvastatin Calcium Tablets IP 10mg
  
• Rosuvastatin Calcium Tablets IP 20mg
• Rosuvastatin Calcium Tablets IP 40mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• a) Rosuvastatin Calcium Tablets IP 5mg
  Each film-coated tablet contains:
  Rosuvastatin calcium IP
  Equivalent to Rosuvastatin…….……….5mg
  Excipients……………………………………q. s
  Colours: Indigo Blue
• b) Rosuvastatin Calcium Tablets IP 10mg
  Each film-coated tablet contains:
  Rosuvastatin calcium IP
  Equivalent to Rosuvastatin…….…………10mg
  Excipients………………………………….…. q. s
  Colours: Titanium Dioxide
• c) Rosuvastatin Calcium Tablets IP 20mg
  Each film-coated tablet contains:
  Rosuvastatin calcium IP
  Equivalent to Rosuvastatin……………….20mg
  Excipients………………………………….…. q. s
  Colours: Iron oxide Red
• d) Rosuvastatin Calcium Tablets IP 40mg
  Each film-coated tablet contains:
  Rosuvastatin calcium IP
  Equivalent to Rosuvastatin………………40mg
  Excipients……………………………………q. s
  Colours: Iron Oxide Yellow

THERAPEUTIC INDICATIONS:

• Adults, adolescents and children aged 6 years or older with primary hypercholesterolemia (type IIa including heterozygous familial hypercholesterolemia) or mixed dyslipidemia (type IIb) as an adjunct to diet when response to diet and other non-pharmacological treatments (e.g., exercise, weight reduction) is inadequate.

CAUTION & WARNING:

• CAUTION:
  Read enclosed leaflet before use.
  Keep medicine out of reach of children.
  SWALLOW WHOLE DO NOT CHEW OR CRUSH
• SCHEDULE “H” Prescription Drug-Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber

STORAGE & DOSAGE:

• Storage: Store at controlled room temperature, 20-25°C.
  Blister pack: Store in the original blister packs to protect from moisture.
  Container pack: Keep the plastic container tightly closed to protect from moisture.
• Dosage: As directed by the Physician.

Rosuvastatin Calcium Tablets 5mg (Rosutaj) 

Rosuvastatin Calcium Tablets 5mg (Rosutaj) is one of the most prescribed cholesterol-lowering medicines worldwide. It belongs to the statin class of drugs, which work by inhibiting HMG-CoA reductase, the enzyme responsible for cholesterol synthesis in the liver. This results in reduced LDL (“bad” cholesterol), increased HDL (“good” cholesterol), and lowered triglyceride levels.

By controlling lipid levels, Rosuvastatin Calcium Tablets 5mg significantly reduce the risk of heart attacks, strokes, and other cardiovascular events—making it a cornerstone therapy in preventive cardiology.

Global demand for Rosuvastatin Calcium Tablets 5mg (Rosutaj) continues to grow, especially in markets focusing on cardiovascular health awareness and preventive care. As chronic lifestyle diseases surge globally, healthcare systems are increasingly relying on high-quality, affordable generic statins.

For Importers, Exporters & Global Buyers 

Taj Pharma is a WHO-GMP & ISO-certified manufacturer based in Vapi, Gujarat, India, recognized globally for its excellence in pharmaceutical manufacturing and export compliance. For importers and distributors, Taj Pharma provides a complete regulatory, packaging, and logistics support system, ensuring smooth market entry and sustained business growth.

Regulatory Documentation Provided

• WHO-GMP & EU-GMP certificates

• Certificate of Pharmaceutical Product (COPP)

• Drug Master File (DMF)

• CTD/eCTD dossiers for product registration

• Free Sale Certificate

• Stability Data (Zone-specific as per ICH guidelines)

Custom Packaging & Labeling

• Country-specific language translations

• Blister, strip, or bottle packaging options

• Tamper-proof and moisture-resistant packaging

• Branding aligned with PCD franchise or private label needs

Shelf-Life, Storage & Dosage

• Shelf-life: 36 months from manufacturing date

• Storage: Store below 25°C, in a dry place, protected from light

• Dosage Form: Film-coated tablet

• Strength: Rosuvastatin Calcium equivalent to 5mg Rosuvastatin

Export Certifications

• WHO-GMP

• EU-GMP

• COA (Certificate of Analysis)

• COPP

• FSC (Free Sale Certificate)

• GMP Compliance Report

• ISO 9001:2015

Target Export Markets

Taj Pharma exports Rosuvastatin Calcium Tablets 5mg (Rosutaj) to more than 40 countries including:

• Vietnam, Philippines, Myanmar, Sri Lanka

• Kenya, Nigeria, Ghana, Tanzania, Ethiopia

• UAE, Oman, Saudi Arabia, Iraq, Yemen

• Peru, Chile, Ecuador, Bolivia

• Ukraine, Belarus, Russia, Kazakhstan

Why Taj Pharma is the Most Trusted Manufacturer, Supplier & Exporter

1. State-of-the-Art Manufacturing Facilities

• Located in Vapi, Gujarat, Taj Pharma’s manufacturing units comply with WHO-GMP, USFDA, and EU GMP standards.

• Equipped with automated production lines and controlled cleanroom environments for contamination-free manufacturing.

2. Affordable Pricing & Quality Assurance

• Competitive ex-factory pricing to help distributors maximize margins.

• Zero-compromise quality policy backed by in-house QC & QA teams.

3. Global Supply Chain Support

• On-time delivery to any destination worldwide.

• Partnerships with reliable freight forwarders for air & sea shipments.

4. Proven International Presence

Taj Pharma is a trusted name in over 40 countries, catering to government tenders, hospital supply chains, and private distributors.

Top 20 Countries Where we  Exports Rosuvastatin Calcium Tablets 5mg (Rosutaj)

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

If you are an importer, distributor, or PCD Pharma franchise owner looking for a reliable Rosuvastatin Calcium Tablets 5mg (Rosutaj) manufacturer in India, Taj Pharma offers world-class quality, competitive pricing, and full regulatory support.

📩 Email: export@tajpharma.com
🌐 Website: www.tajpharma.com

Top 20 FAQs 

1. What is Rosuvastatin Calcium Tablets 5mg (Rosutaj) used for?
It is used to lower LDL cholesterol, increase HDL cholesterol, and reduce triglycerides to prevent heart attacks and strokes.

2. Is Taj Pharma WHO-GMP certified?
Yes, Taj Pharma holds WHO-GMP and other international certifications for pharmaceutical manufacturing.

3. Can Rosuvastatin Calcium Tablets 5mg be taken with food?
Yes, it can be taken with or without food.

4. What is the shelf-life of Rosutaj?
36 months from the date of manufacture.

5. Does Taj Pharma provide country-specific labeling?
Yes, customized labeling and packaging are available.

6. Is Rosuvastatin safe for long-term use?
Yes, it is widely prescribed for long-term management of cholesterol.

7. Can pregnant women take Rosuvastatin?
No, it is contraindicated in pregnancy and breastfeeding.

8. Does Taj Pharma assist with product registration?
Yes, complete CTD dossiers and regulatory documents are provided.

9. What is the minimum export order?
Varies by market; contact Taj Pharma for details.

10. Are there side effects?
Possible mild effects include muscle pain, nausea, headache, or abdominal discomfort.

11. Can it be shipped by air and sea?
Yes, Taj Pharma ships globally via both modes.

12. Does Taj Pharma supply to government tenders?
Yes, including UN and Ministry of Health procurements.

13. Is Rosuvastatin Calcium Tablets 5mg available for PCD franchise?
Yes, exclusive territories are offered.

14. Does Taj Pharma offer price protection for long-term contracts?
Yes, upon agreement.

15. Can Taj Pharma supply in bulk API form?
Yes, both finished formulations and API are available.

16. Which countries import Rosutaj?
Over 40 countries across Asia, Africa, Latin America, and CIS.

17. How should Rosutaj be stored?
Store in a cool, dry place below 25°C.

18. Does Taj Pharma offer private labeling?
Yes, with full design and branding support.

19. Is Taj Pharma an Indian government-approved exporter?
Yes, with valid export licenses.

20. How can I place an order?
Contact Taj Pharma’s export team via email or phone.