Description

Rosuvastatin Tablets (5mg – 40mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)

Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a specialized Manufacturer of Rosuvastatin Tablets in India. Rosuvastatin is a highly potent HMG-CoA Reductase Inhibitor (Statin), widely considered the most effective statin for lowering Low-Density Lipoprotein (LDL) cholesterol and raising High-Density Lipoprotein (HDL) levels.

We offer Contract Manufacturing (Third Party) services for this high-demand cardiovascular drug. Rosuvastatin Calcium is chemically sensitive to acidic environments and moisture. Our WHO-GMP certified facility in Mumbai utilizes specialized alkalizing formulations and moisture-controlled suites to ensure stability. Healthy Inc manages the export logistics, supplying pharmacy chains and cardiology centers across the USA, Europe, and Southeast Asia (where specific lower-dosage protocols are often required).

2. Product Specifications

3. Manufacturing Technology

Stability and bioavailability are the key challenges.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Stabilization: Rosuvastatin Calcium can degrade into lactones in acidic conditions. We use Tribasic Calcium Phosphate or other alkalizing agents in the tablet matrix to maintain a micro-environmental pH that ensures the drug remains stable.

  • Moisture Control: The API is hygroscopic. We manufacture in Dehumidified Suites (< 30% RH) to prevent hydrolysis.

  • Film Coating: We use a moisture-barrier Opadry II Coating to protect the tablet core and ensure smooth swallowing.

• The Exporter: Healthy Inc

  • Alu-Alu Packaging: Because of the molecule’s sensitivity to light and moisture, we primarily recommend Alu-Alu Cold Form Blisters for export, which provide the highest level of protection compared to standard PVC/PVDC.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >80% of the drug releases within 30 minutes.

• Assay: We confirm the potency is strictly within 90-110% of the label claim.

• Impurity Profiling: We strictly monitor for degradation products (anti-isomers and lactones) to ensure safety over the 3-year shelf life.

5. Why Use Rosuvastatin?

It is the “Powerhouse” of cholesterol reduction.

• Mechanism: It competitively inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis.

• Key Indications:

  • Hyperlipidemia: Lowers LDL (“bad” cholesterol) by 45-63% (dose-dependent), significantly more than Atorvastatin or Simvastatin.

  • Arterial Plaque: Proven to slow the progression of atherosclerosis (hardening of arteries).

  • Hypertriglyceridemia: Reduces triglycerides.

• Advantage: Unlike Simvastatin, it has a long half-life (19 hours) and can be taken at any time of day.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Rosuvastatin Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Why is the 40mg dose restricted?

  A: The 40mg dose carries a higher risk of rhabdomyolysis (muscle breakdown). It is reserved only for patients who do not achieve goals on 20mg.

• Q: Is it safe for Asian patients?

  A: Caution is needed. Studies show Asian subjects have 2x higher plasma exposure to Rosuvastatin compared to Caucasians. A lower starting dose (5mg) is recommended for Asian markets.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Dosage: 10mg once daily.

• Dose Range: 5mg to 40mg.

• Administration: Swallow whole. Can be taken at any time of day, with or without food.

9. Side Effects and Precautions

• Myopathy: Muscle pain/weakness. Risk increases with dose and age (>65).

• Diabetes: Small risk of increased HbA1c and fasting serum glucose levels.

• Liver Enzymes: Monitor transaminases (ALT/AST).

• Renal: Proteinuria (protein in urine) may occur at 40mg dose.

10. Storage Instructions

• Store below 30°C in a dry place.

• Protect from moisture and light.