GENERIC NAME OF THE MEDICINAL PRODUCT:
Atorvastatin Calcium Tablet USP 10mg (ATORTAJ)
Atorvastatin Calcium Tablet USP 20mg (ATORTAJ)
Atorvastatin Calcium Tablet USP 40mg (ATORTAJ)
Atorvastatin Calcium Tablet USP 80mg (ATORTAJ)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each film coated tablet contains:
Atorvastatin Calcium USP
Equivalent to Atorvastatin………….5mg
Excipients…………………………… q.s.
Colour: Red Oxide iron
b) Atorvastatin Calcium Tablet USP 10mg
Each film coated tablet contains:
Atorvastatin Calcium USP
Equivalent to Atorvastatin………….10mg
Excipients…………………………… q.s.
Colour: Ferric oxide red
c) Atorvastatin Calcium Tablet USP 20mg
Each film coated tablet contains:
Atorvastatin Calcium USP
Equivalent to Atorvastatin………….20mg
Excipients…………………………… q.s.
Colour: Quinoline yellow SS
d) Atorvastatin Calcium Tablet USP 40mg
Each film coated tablet contains:
Atorvastatin Calcium USP
Equivalent to Atorvastatin………….40mg
Excipients…………………………… q.s.
Colour: Allura red
e) Atorvastatin Calcium Tablet USP 80mg
Each film coated tablet contains:
Atorvastatin Calcium USP
Equivalent to Atorvastatin………….80mg
Excipients…………………………… q.s.
Colour: Ferric oxide yellow
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.
Atorvastatin Calcium Tablet 5mg Technical Specification:
| Product Name: |
Atorvastatin Calcium Tablet USP |
| Brand Name: | ATORTAJ |
| Strength: | (5mg), (10mg), (20mg), (40mg), (80mg) |
| Dosage Form: | Tablets (Film coated) |
| Route of Administration: | Via oral Route |
| Packing: | 30s, 90s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Anti-hyperlipidaemic, Cardiology |
| Indication: | A drug used to lower the amount of cholesterol in the blood and to prevent stroke, heart attack, and angina (chest pain). It is also being studied in the prevention and treatment of some types of cancer and other conditions. Atorvastatin calcium blocks an enzyme that helps make cholesterol in the body. |
| 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:
- Atorvastatin Calcium Tablet USP 5mg (ATORTAJ)
- Atorvastatin Calcium Tablet USP 10mg (ATORTAJ)
- Atorvastatin Calcium Tablet USP 20mg (ATORTAJ)
- Atorvastatin Calcium Tablet USP 40mg (ATORTAJ)
- Atorvastatin Calcium Tablet USP 80mg (ATORTAJ)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- a) Atorvastatin Calcium Tablet USP 5mg
Each film coated tablet contains:
Atorvastatin Calcium USP
Equivalent to Atorvastatin………….5mg
Excipients…………………………… q.s.
Colour: Red Oxide iron - b) Atorvastatin Calcium Tablet USP 10mg
Each film coated tablet contains:
Atorvastatin Calcium USP
Equivalent to Atorvastatin………….10mg
Excipients…………………………… q.s.
Colour: Ferric oxide red - c) Atorvastatin Calcium Tablet USP 20mg
Each film coated tablet contains:
Atorvastatin Calcium USP
Equivalent to Atorvastatin………….20mg
Excipients…………………………… q.s.
Colour: Quinoline yellow SS - d) Atorvastatin Calcium Tablet USP 40mg
Each film coated tablet contains:
Atorvastatin Calcium USP
Equivalent to Atorvastatin………….40mg
Excipients…………………………… q.s.
Colour: Allura red - e) Atorvastatin Calcium Tablet USP 80mg
Each film coated tablet contains:
Atorvastatin Calcium USP
Equivalent to Atorvastatin………….80mg
Excipients…………………………… q.s.
Colour: Ferric oxide yellow
THERAPEUTIC INDICATIONS:
- A drug used to lower the amount of cholesterol in the blood and to prevent stroke, heart attack, and angina (chest pain). It is also being studied in the prevention and treatment of some types of cancer and other conditions. Atorvastatin calcium blocks an enzyme that helps make cholesterol in the body.
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 Atorvastatin Calcium Tablet 5mg (ATORTAJ)
Atorvastatin Calcium Tablet 5mg (ATORTAJ) is a widely prescribed cholesterol-lowering medicine that belongs to the statin class of drugs. Statins inhibit the HMG-CoA reductase enzyme, which plays a key role in cholesterol production in the liver. By lowering cholesterol, this medicine reduces the risk of cardiovascular diseases such as heart attacks and strokes.
Globally, high cholesterol is a leading risk factor for heart disease, making Atorvastatin Calcium Tablet 5mg (ATORTAJ) one of the most sought-after medications. Patients with mild to moderate hypercholesterolemia often start treatment at a 5mg dose. The demand is further driven by preventive healthcare programs and the rising awareness of cardiovascular health.
Taj Pharma, based in Vapi, Gujarat, is recognized as a top manufacturer, exporter, and supplier of Atorvastatin Calcium Tablet 5mg (ATORTAJ), delivering high-quality, safe, and reliable medicines to global markets.
In-Depth Details for Importers, Exporters, and Buyers
Regulatory Documentation Provided
Taj Pharma ensures comprehensive documentation for smooth import and regulatory approval in international markets. These include:
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Certificate of Analysis (CoA) for every batch
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Batch Manufacturing Record (BMR) ensuring quality control
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Drug Master File (DMF) for regulatory submissions
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Certificates of Pharmaceutical Product (COPP)
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Safety and efficacy reports for import compliance
Custom Packaging & Labeling
Global buyers can benefit from Taj Pharma’s customizable packaging solutions:
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Blister packs or bottles according to client requirements
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Tamper-evident packaging to ensure safety
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Child-resistant features
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Multi-language labeling to comply with local regulatory norms
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Options for private labeling for distributors
Shelf-Life, Storage, and Dosage Form
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Shelf-life: 24 months from manufacturing
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Storage: Store in a cool, dry place below 25°C; avoid moisture and sunlight
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Dosage Form: Tablet, 5mg
Export Certifications
Taj Pharma holds globally recognized certifications to support export compliance:
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WHO-GMP Certification
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EU-GMP Certification
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COPP for international export
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CTD Dossier for regulatory submissions in multiple countries
Target Countries & Export Markets
Atorvastatin Calcium Tablet 5mg (ATORTAJ) is exported worldwide, including:
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Middle East: UAE, Saudi Arabia, Qatar, Oman
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Africa: Nigeria, Kenya, South Africa
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Asia: Bangladesh, Nepal, Sri Lanka
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Europe: UK, Germany, France, Italy
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Latin America: Brazil, Mexico
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Southeast Asia: Malaysia, Singapore, Philippines, Indonesia
Why is the Most Trusted Manufacturer, Supplier, and Exporter
State-of-the-Art Manufacturing
Taj Pharma’s manufacturing facilities are equipped with advanced technology to ensure quality and safety:
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Automated tablet compression and coating machines
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State-of-the-art packaging lines
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ISO and GMP-certified production units
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In-house quality control labs for rigorous testing
Affordable Pricing & Quality Assurance
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Competitive pricing for bulk orders
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High-quality standards ensuring consistency across batches
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Third-party verification available for global buyers
Global Presence & Supply Chain Support
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Reliable logistics for both air and sea shipments
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Comprehensive export documentation support
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Efficient supply chain to ensure timely delivery worldwide
Top 20 Countries Exporting
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UAE
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Saudi Arabia
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Oman
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Qatar
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Kenya
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Nigeria
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South Africa
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Bangladesh
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Nepal
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Sri Lanka
-
UK
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Germany
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France
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Italy
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Brazil
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Mexico
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Malaysia
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Singapore
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Philippines
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Indonesia
Technical Product Specification Table
| Parameter | Specification |
|---|---|
| Medicine Name | Atorvastatin Calcium Tablet 5mg (ATORTAJ) |
| Dosage Form | Tablet |
| Strength | 5mg |
| Manufacturer | Taj Pharma Ltd, Vapi, Gujarat, India |
| Shelf Life | 24 months |
| Storage Conditions | Below 25°C, dry place, avoid sunlight |
| Regulatory Certifications | WHO-GMP, EU-GMP, COPP, CTD Dossier |
| Packaging Options | Blister packs, bottles, bulk |
| Therapeutic Class | Statin (Cholesterol-lowering) |
Benefits of Atorvastatin Calcium Tablet 5mg (ATORTAJ)
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Reduces total cholesterol, LDL, and triglycerides
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Helps prevent cardiovascular events in at-risk patients
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Safe for long-term therapy when taken as prescribed
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Easy to administer, can be taken with or without food
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Helps improve overall heart health
Dosage Instructions and Recommendations
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Take at the same time every day for consistent effectiveness
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Can be taken with a meal or on an empty stomach
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Regular cholesterol monitoring is recommended
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Follow a healthy diet, regular exercise, smoking cessation, and moderate alcohol intake alongside the medication
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Avoid stopping the medication without consulting a doctor, as cholesterol levels may rise
Side Effects of Atorvastatin Calcium Tablet 5mg (ATORTAJ)
Although generally well-tolerated, some patients may experience:
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Headache or dizziness
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Nausea or vomiting
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Abdominal pain or discomfort
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Muscle aches or weakness
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Rarely, liver enzyme elevation (requires monitoring)
Call to Action for Buyers and Distributors
Taj Pharma is the trusted global partner for Atorvastatin Calcium Tablet 5mg (ATORTAJ). We offer:
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Bulk supply for distributors and wholesalers
-
Private labeling and custom packaging options
-
Global export support and documentation
-
Reliable and timely delivery worldwide
Contact Us:
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Email: export@tajpharma.com
Top 20 FAQs
-
What is Atorvastatin Calcium Tablet 5mg used for?
To lower cholesterol and prevent cardiovascular diseases. -
Can it be taken with food?
Yes, with or without meals. -
Is it safe for long-term use?
Yes, under medical supervision. -
What are common side effects?
Headache, muscle aches, nausea, mild digestive discomfort. -
Should cholesterol levels be monitored?
Yes, regular blood tests are recommended. -
Can I stop the medicine abruptly?
No, stopping may increase cholesterol and heart disease risk. -
Is it suitable for pregnant women?
Only under strict medical supervision. -
Can alcohol be consumed?
In moderation; excess may increase side effects. -
How long before seeing results?
Usually 2–4 weeks for noticeable improvement. -
Can it be combined with other medicines?
Consult your doctor for interactions. -
What storage conditions are recommended?
Below 25°C, away from moisture and sunlight. -
Does Taj Pharma provide export documentation?
Yes, including WHO-GMP, EU-GMP, COPP, and CTD dossier. -
Is private labeling available for distributors?
Yes, customizable packaging is provided. -
What is the shelf-life of the tablets?
24 months from manufacturing date. -
Is it effective for mild cholesterol elevation?
Yes, the 5mg dose is ideal for initial therapy. -
Can children take this medicine?
Pediatric use is only under medical supervision. -
Is it available worldwide?
Yes, Taj Pharma exports globally. -
What is the mechanism of action?
Inhibits HMG-CoA reductase, reducing cholesterol production. -
How does it prevent heart disease?
By lowering cholesterol, it reduces plaque buildup in arteries. -
Can lifestyle changes enhance its effectiveness?
Yes, diet, exercise, and smoking cessation improve outcomes.






