Description

Rosuvastatin Calcium Tablets (5 mg / 10 mg / 20 mg / 40 mg)

Healthy Inc is a specialized global supplier of high-potency cardiovascular therapies. We provide premium Rosuvastatin Calcium Tablets, manufactured in WHO–GMP certified solid dosage facilities. As a leading high-intensity statin, this product is a primary export for cardiology departments, metabolic syndrome clinics, and National Health Tenders in Europe, Southeast Asia, and the Middle East.

Product Overview

Rosuvastatin is a synthetic, hydrophilic lipid-lowering agent. It is considered one of the most potent members of the statin class, engineered to achieve significant reductions in LDL cholesterol and triglycerides while increasing HDL levels at lower doses than earlier generation statins.

The “High-Intensity” Statin Specialist:

• Mechanism of Action: Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a precursor of cholesterol. Its high binding affinity to the enzyme ensures maximal hepatic cholesterol synthesis inhibition.
• Hydrophilic Advantage: Unlike lipophilic statins, Rosuvastatin is hepatoselective. Its hydrophilic nature reduces its uptake into extrahepatic tissues like skeletal muscle, potentially lowering the risk of muscle-related side effects (myopathy).
• Atherosclerosis Regression: Clinical data (such as the ASTEROID trial) has demonstrated that Rosuvastatin can lead to the actual regression of coronary atherosclerosis, rather than just slowing its progression.

Technical & Manufacturing Specifications

Formulated for superior molecular stability and rapid intestinal absorption.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from ISO 9001:2015 certified units.

• Stability Engineering: Rosuvastatin is sensitive to moisture and acidic environments. Our tablets utilize alkaline stabilizing agents and a specialized moisture-barrier film coating to prevent degradation into lactone impurities.
• Precision Micronization: The API undergoes controlled micronization to ensure a uniform particle size distribution, which is critical for achieving consistent $C_{max}$ and $AUC$ values across different patient populations.
• Bioequivalence Validation: Every batch is tested against the innovator (Crestor) to ensure identical dissolution profiles, facilitating seamless therapeutic substitution in clinical settings.

Therapeutic Indications & Clinical Symptoms

• Primary Hypercholesterolemia: Treatment of patients with Type IIa and IIb hyperlipidemia to reduce Total-C, LDL-C, and ApoB.
• Hypertriglyceridemia: Adjunct therapy to diet for patients with elevated serum triglyceride levels (Type IV).
• Primary Prevention: Reduction in the risk of myocardial infarction, stroke, and arterial revascularization procedures in individuals without clinically evident CHD but with multiple risk factors.
• Homozygous Familial Hypercholesterolemia: Reduction of LDL-C in specialized high-risk genetic cases.

Dosage & Administration

• Flexible Dosing: Unlike some other statins, Rosuvastatin can be taken any time of day, with or without food, due to its long half-life (~19 hours).
• Initial Dose: Typically 5 mg to 10 mg once daily. The 40 mg dose is reserved for patients who do not reach their LDL goal at 20 mg.
• Ethnic Consideration: Lower starting doses (5 mg) are recommended for patients of Asian descent due to increased systemic exposure.

Global Export & Contract Manufacturing Services

Healthy Inc is a verified Pharmaceutical Exporter in Mumbai, catering to Institutional Wholesalers and Ministry of Health Tenders. We offer Third Party Manufacturing for Rosuvastatin with full CTD Dossier and COPP support. Our logistics network ensures secure transit to Vietnam, Philippines, UAE, and the CIS region, providing WHO-GMP quality at competitive B2B prices.

Commercial Inquiries

WhatsApp/Call: +91 7710003340
Email: info@healthyinc.co.in