Description

Simvastatin 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 Simvastatin Tablets in India. Simvastatin is a widely prescribed HMG-CoA Reductase Inhibitor (Statin) used to lower levels of “bad” cholesterol (Low-Density Lipoprotein, or LDL) and triglycerides in the blood, while raising “good” cholesterol (High-Density Lipoprotein, or HDL).

We offer Contract Manufacturing (Third Party) services for this essential lipid-lowering agent. Unlike newer long-acting statins (like Atorvastatin), Simvastatin has a distinct short half-life and is specifically designed to be taken in the evening to target the body’s peak cholesterol synthesis period. Our WHO-GMP certified facility in Mumbai utilizes oxidation-protected processing environments to ensure the stability of this molecule. Healthy Inc manages the export logistics, supplying pharmacy chains and cardiovascular clinics across Europe, Southeast Asia, and Latin America.

2. Product Specifications

*Note: 80mg strength use is restricted in many countries due to myopathy risk.

3. Manufacturing Technology

Simvastatin is a prodrug that requires careful formulation to maintain stability.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Oxidation Protection: Simvastatin is sensitive to oxidation. We incorporate specific antioxidants (like BHA/BHT or Ascorbic Acid) in the formulation and process the granules in inert environments to prevent degradation into inactive by-products.

  • Prodrug Stability: Simvastatin is a lactone prodrug that hydrolyzes to its active acid form in the body. We ensure the tablet pH is optimized during manufacturing to prevent premature hydrolysis in the pack.

  • Film Coating: We use a moisture-barrier Film Coating (Opadry) to further protect the tablet core and ensure a smooth finish for easy swallowing.

• The Exporter: Healthy Inc

  • Calendar Packaging: To improve patient adherence for this daily medication, we offer Calendar Blister Packs (marked Mon-Sun), which are highly preferred in European and Western markets.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Assay: We use HPLC to ensure the potency is strictly within 90-110% of the label claim.

• Dissolution: We test release profiles to ensure >75% of the drug releases within 30 minutes.

• Impurity Profiling: We strictly monitor for degradation products, specifically Simvastatin Acid (which should only form inside the body) and oxidation impurities.

5. Why Use Simvastatin?

It is a time-tested, cost-effective solution for cholesterol control.

• Mechanism: It competitively inhibits the enzyme HMG-CoA reductase, which is the rate-limiting step in cholesterol biosynthesis in the liver. This forces the liver to pull more LDL cholesterol out of the bloodstream.

• Key Indications:

  • Hyperlipidemia: Reduction of elevated Total-C, LDL-C, Apo B, and TG levels.

  • Cardiovascular Risk Reduction: Proven to reduce the risk of myocardial infarction (heart attack) and stroke in patients with existing heart disease or diabetes (4S Study).

  • Heterozygous Familial Hypercholesterolemia: Used in adolescents (10-17 years) and adults.

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 Simvastatin Tablets?

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

• Q: Why must it be taken at night?

  A: The liver produces the most cholesterol while you sleep. Because Simvastatin has a shorter half-life (2-3 hours) compared to Atorvastatin, it works best when active during this peak production time.

• Q: Can I eat Grapefruit while taking this?

  A: No. Grapefruit juice significantly increases Simvastatin levels in the blood, leading to a high risk of muscle toxicity. It should be avoided.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Dosage: 10mg to 40mg once daily in the evening.

• Maximum Dose: 40mg. (The 80mg dose is restricted to patients who have been on it chronically without issues, due to high risk of myopathy).

• Administration: Swallow whole. Can be taken with or without food.

9. Side Effects and Precautions

• Myopathy/Rhabdomyolysis: Muscle pain, tenderness, or weakness. Risk increases with higher doses or drug interactions (e.g., Verapamil, Amiodarone).

• Liver Enzymes: May cause transient elevation of serum transaminases (ALT/AST).

• Diabetes: Small risk of increased blood sugar levels (benefit usually outweighs risk).

• Contraindications: Active liver disease, pregnancy, and nursing mothers.

10. Storage Instructions

• Store below 30°C in a dry place.

• Do not store in the bathroom. Keep away from light.