Description
Simvastatin Tablets (10 mg / 20 mg / 40 mg / 80 mg)
Healthy Inc is a specialized global supplier of high-stability cardiovascular therapies. We provide premium Simvastatin Tablets, manufactured in WHO–GMP certified solid dosage facilities. As a foundation of lipid-lowering therapy, this product is a primary export for cardiology clinics, geriatric care centers, and National Health Tenders in Europe, Southeast Asia, and the CIS region.
Product Overview
Simvastatin is a lipid-altering agent derived synthetically from a fermentation product of Aspergillus terreus. It is an inactive lactone prodrug that is hydrolyzed in the liver to its active beta-hydroxy acid form, a potent inhibitor of cholesterol synthesis.
The “Cholesterol Control” Specialist:
- Mechanism of Action: Simvastatin competitively inhibits 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. By blocking this rate-limiting enzyme in the mevalonate pathway, it reduces hepatic cholesterol synthesis and increases the expression of LDL receptors on hepatocyte membranes, leading to the rapid clearance of circulating LDL-C (“bad” cholesterol).
- Pleiotropic Benefits: Beyond lowering lipids, Simvastatin improves endothelial function, stabilizes atherosclerotic plaques, and exhibits anti-inflammatory properties, significantly reducing the risk of myocardial infarction and stroke.
- Efficacy Profile: It provides a dose-dependent reduction in Total Cholesterol, LDL-C, and Triglycerides, while producing a modest increase in HDL-C (“good” cholesterol).
Technical & Manufacturing Specifications
Formulated for precise active ingredient stability and optimized bioavailability.
| Technical Metric | Specification Standard |
|---|---|
| Active Ingredient | Simvastatin BP / USP / IP |
| Dosage Form | Film-Coated Tablets |
| Available Strengths | 10 mg, 20 mg, 40 mg, 80 mg |
| HS Code | 3004.90.99 (Medicaments) / 2932.20.90 |
| Packaging | Alu-Alu Blister or PVC/PVDC (Oxygen & Moisture Barrier) |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from ISO 9001:2015 certified units.
- Oxidation Protection: Simvastatin is highly sensitive to oxidation. Our formulation includes a balanced antioxidant system (e.g., Butylated Hydroxyanisole/Ascorbic Acid) and utilizes nitrogen-purged packaging to ensure chemical integrity for 36 months.
- Lactone Stability: We maintain strict pH controls during the granulation process to prevent the premature hydrolysis of the lactone ring, ensuring the prodrug reaches the liver in its intended form.
- Bioequivalence: Every batch is validated against the innovator profile (Zocor) using multi-point dissolution testing to ensure identical clinical efficacy.
Therapeutic Indications & Clinical Symptoms
- Hypercholesterolemia: Reduction of elevated total and LDL cholesterol in patients with primary hypercholesterolemia.
- Coronary Heart Disease (CHD): Secondary prevention to reduce the risk of total mortality, non-fatal myocardial infarction, and revascularization procedures.
- Hypertriglyceridemia: Adjunctive therapy to diet for the treatment of patients with elevated serum triglyceride levels.
Dosage & Administration
- Evening Administration: Since cholesterol synthesis occurs primarily at night, Simvastatin is most effective when taken as a single dose in the evening.
- Dosage Range: 5 mg to 40 mg daily. The 80 mg dose is restricted to patients at high risk for cardiovascular complications who have not achieved their LDL goal on lower doses.
- Safety Note: Contraindicated in patients with active liver disease or during pregnancy. Patients should report any unexplained muscle pain (risk of myopathy/rhabdomyolysis).
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 Simvastatin with full CTD Dossier and COPP support. Our logistics network ensures secure transit to Vietnam, Philippines, UK, and the CIS region, providing WHO-GMP quality at competitive B2B prices.
Commercial Inquiries
WhatsApp/Call: +91 7710003340
Email: info@healthyinc.co.in










