Rosuvastatin Calcium Tablets 20mg (Rosutaj)

Rosuvastatin Calcium Tablets 20mg 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.

Introduction to Rosuvastatin Calcium Tablets 20mg (Rosutaj)

Rosuvastatin Calcium Tablets 20mg (Rosutaj), manufactured by Taj Pharma India, is a trusted cholesterol-lowering medication belonging to the statin group. It effectively reduces LDL cholesterol, triglycerides, and total cholesterol levels while increasing HDL (“good” cholesterol).

Globally, cardiovascular disease remains one of the leading causes of death, and statin demand is growing rapidly—particularly in North America, Europe, Africa, and Southeast Asia. As a widely prescribed medicine, Rosuvastatin 20mg is recommended for patients at risk of heart attacks, strokes, and atherosclerosis.

Taj Pharma, with its WHO-GMP-certified facilities in Vapi, Gujarat, ensures each batch of Rosutaj 20mg meets international standards, offering purity, potency, and safety for both domestic and global markets.

In-Depth Details for Importers, Exporters & Global Buyers

When sourcing Rosuvastatin Calcium Tablets 20mg (Rosutaj) from Taj Pharma, buyers benefit from a complete pharmaceutical export package, making international procurement seamless.

Regulatory Documentation Provided

Taj Pharma supplies all essential export and regulatory compliance documents, including:

• WHO-GMP & EU-GMP Certificates

• Certificate of Pharmaceutical Product (COPP) as per WHO format

• Good Manufacturing Practice (GMP) compliance reports

• CTD / ACTD Dossiers for market registration

• Free Sale Certificate

• COA (Certificate of Analysis) for every batch

• Stability data as per ICH guidelines

• MSDS (Material Safety Data Sheet)

Custom Packaging & Labeling

• Blister & Alu-Alu Packs with moisture protection

• Custom branding for PCD franchise partners

• Multilingual labeling for country-specific requirements

• Tamper-proof, export-grade cartons

Shelf-Life, Storage & Dosage Form

• Dosage Form: Film-coated tablets

• Strength: Rosuvastatin Calcium equivalent to 20mg Rosuvastatin

• Shelf-Life: 24 to 36 months (as per country requirement)

• Storage: Store below 30°C, protect from moisture and light

Export Certifications

Taj Pharma holds internationally recognized certifications, including:

• WHO-GMP (World Health Organization Good Manufacturing Practice)

• EU-GMP (European Union GMP)

• ISO 9001:2015 Quality Management

• COPP for multiple countries

• Regulatory dossiers for more than 50 countries

Target Countries & Export Markets

Taj Pharma exports Rosuvastatin Calcium Tablets 20mg (Rosutaj) to:

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

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

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

• Europe & CIS: Russia, Ukraine, Belarus, Kazakhstan

• Latin America: Peru, Chile, Bolivia, Ecuador

Why is the Most Trusted Manufacturer & Exporter

State-of-the-Art Manufacturing

Taj Pharma operates USFDA-approvable facilities with cGMP compliance, ensuring every Rosuvastatin Calcium 20mg tablet meets strict quality parameters. Advanced R&D labs allow for formulation optimization, ensuring consistent bioavailability.

Affordable Pricing & Quality Assurance

While meeting global quality standards, Taj Pharma ensures competitive pricing, enabling importers to maximize margins without compromising on efficacy and safety.

Global Presence & Supply Chain Support

With exports to over 50 countries, Taj Pharma offers just-in-time delivery, regulatory support, and country-specific dossier customization.

Top 20 Countries Where Taj Pharma Exports Rosutaj 20mg

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 a pharmaceutical importer, distributor, or PCD pharma franchise partner, Taj Pharma offers:

• Guaranteed WHO-GMP quality

• Customizable packaging & private labeling

• Regulatory and logistics support

• Best market prices

📞 Contact Taj Pharma today to source premium-quality Rosuvastatin Calcium Tablets 20mg (Rosutaj) for your market.
🌐 Visit: www.tajpharma.com

Top 20 FAQs

Q1: What is Rosuvastatin Calcium 20mg used for?
A: It lowers LDL cholesterol, triglycerides, and prevents cardiovascular diseases.

Q2: Is Rosuvastatin 20mg safe for long-term use?
A: Yes, under medical supervision, it’s safe for long-term therapy.

Q3: Can Rosuvastatin be taken without food?
A: Yes, it can be taken with or without meals.

Q4: Is Rosutaj 20mg WHO-GMP certified?
A: Yes, Taj Pharma’s facilities are WHO-GMP and EU-GMP certified.

Q5: Can pregnant women take Rosuvastatin?
A: No, it’s contraindicated in pregnancy and breastfeeding.

Q6: Does Taj Pharma offer PCD pharma franchise?
A: Yes, nationwide PCD franchise opportunities are available.

Q7: What is the shelf life of Rosutaj 20mg?
A: Typically 24–36 months, depending on storage and packaging.

Q8: How does Taj Pharma ensure quality?
A: Through stringent QC, QA, and regulatory compliance processes.

Q9: Can I import Rosutaj 20mg to Africa?
A: Yes, Taj Pharma exports extensively to African nations.

Q10: What’s the packing configuration?
A: Alu-Alu or blister packs, customized as per client needs.

Q11: Does Rosuvastatin have side effects?
A: Common ones include mild muscle pain, headache, and nausea.

Q12: Is Rosutaj available in bulk?
A: Yes, bulk supply is available for export.

Q13: Can Taj Pharma provide a CTD dossier?
A: Yes, complete CTD/ACTD dossiers are available.

Q14: Is the medicine suitable for diabetics?
A: Diabetic patients should monitor blood sugar levels during use.

Q15: Does Taj Pharma handle international logistics?
A: Yes, full export support is provided.

Q16: Is Rosutaj available PAN India?
A: Yes, distributed across India.

Q17: Can labels be made in French/Arabic?
A: Yes, multilingual labeling is available.

Q18: Is the drug available in 10mg or 5mg?
A: Yes, other strengths are available on request.

Q19: Can I get exclusive distributorship in my country?
A: Yes, subject to agreement and regulatory approval.

Q20: Why choose Taj Pharma for Rosuvastatin?
A: For certified quality, competitive prices, and unmatched export expertise.