Description

Atorvastatin Tablets (10mg / 20mg / 40mg / 80mg)

Manufactured by Healthy Life Pharma Pvt. Ltd. | Exported by Healthy Inc

1. Product Introduction Healthy Life Pharma Pvt. Ltd. is a specialized manufacturer of Atorvastatin Tablets in India. This HMG-CoA reductase inhibitor (Statin) is the global gold standard for lowering cholesterol and preventing cardiovascular disease. We produce the full range of strengths, including the high-potency 80mg tablet. Our facility adheres to strict WHO-GMP standards. Healthy Inc manages our global exports and cardiology tenders.

2. Product Specifications | Parameter | Specification | | :— | :— | | Product Name | Atorvastatin Tablets | | Generic Name | Atorvastatin Calcium USP / BP / IP | | Strength | 10mg / 20mg / 40mg / 80mg | | Dosage Form | Film Coated Tablet | | Standard | USP / BP / IP Compliant | | Therapeutic Class | Lipid-Lowering Agent (Statin) | | Shelf Life | 24 – 36 Months | | Packaging | 10×10 Blister (Alu-Alu) / 1000s Bulk Jar |

3. Manufacturing Atorvastatin Tablets We divide our operations to ensure specialized focus.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd. First, Healthy Life Pharma handles manufacturing. We operate a WHO-GMP certified plant in Mumbai. Atorvastatin has poor water solubility. To ensure it dissolves properly in the patient’s stomach, we use Micronized API (ultra-fine particles). This increases the surface area of the drug, significantly improving its bioavailability. We also use Alu-Alu Packaging to protect the tablet from moisture and oxidation, which can degrade statins rapidly in tropical climates.

• The Exporter: Healthy Inc Second, Healthy Inc manages international trade. This division handles logistics for Atorvastatin Tablets. We supply pharmacy chains and heart institutes globally. We are capable of supplying the 80mg strength in bulk, which is critical for patients recovering from heart attacks or strokes.

4. Quality Assurance We test every batch rigorously.

• Dissolution Profiling: We ensure the tablet releases the drug consistently, mimicking the bio-profile of the innovator brand.

• Impurity Profiling: Statins are prone to oxidation. We strictly monitor for oxidative impurities to ensure safety.

• Assay: We verify the potency across all strengths (10mg to 80mg) to ensure reliable lipid-lowering effects.

5. Why Use Atorvastatin Tablets? This drug lowers “bad” cholesterol and raises “good” cholesterol.

• Mechanism: It inhibits the enzyme HMG-CoA reductase in the liver. This enzyme is responsible for producing cholesterol.

• Effect: It significantly lowers LDL (Low-Density Lipoprotein) and Triglycerides, while slightly increasing HDL (High-Density Lipoprotein).

Key Indications:

• Hyperlipidemia: Treatment of high cholesterol and mixed dyslipidemia.

• Cardiovascular Prevention: Prevention of heart attack (MI), stroke, and angina in patients with risk factors (diabetes, hypertension, smoking).

• Homozygous Familial Hypercholesterolemia: Treatment of genetic high cholesterol conditions.

6. Export and Regulatory Support We provide complete documentation for registration.

• Dossier: We offer CTD and ACTD formats.

• Certificates: We supply the Free Sale Certificate (FSC) and COPP.

• Logistics: We ship via FOB Mumbai or CIF.

7. Frequently Asked Questions

• Q: Who manufactures Atorvastatin Tablets? A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Do you use Bi-layer technology? A: For Atorvastatin combination products (e.g., with Fenofibrate), we have Bi-layer manufacturing capabilities.

• Q: Is the 80mg tablet scored? A: Yes, typically the higher strength tablets are scored to allow for dose adjustment if necessary.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION (For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Dosage: Range is 10mg to 80mg once daily.

• Timing: Can be taken at any time of day, with or without food (unlike other statins that must be taken at night).

• Monitoring: Liver function tests (LFTs) should be performed before starting therapy.

9. Side Effects and Precautions

• Muscle Pain (Myopathy): The most common side effect is muscle pain or weakness. In rare cases, this can lead to Rhabdomyolysis (severe muscle breakdown).

• Liver Enzymes: May cause a mild increase in liver enzymes.

• Diabetes: Statins may slightly increase blood sugar levels, but the cardiovascular benefit usually outweighs this risk.

10. Storage Instructions

• Store below 25°C in a dry place.

• Moisture Sensitive: Keep in the original packaging.

• Keep out of reach of children.