Product/Composition:- | Simvastatin tablets |
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Strength:- | 5 mg, 10 mg, 20 mg, 40 mg, 80 mg |
Form:- | Tablet |
Reference Brands:- | Zocor(US & EU) |
MOQ | As per the manufacturer batch size |
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Simvastatin inhibits HMG-CoA reductase, reducing cholesterol synthesis in the liver. It effectively lowers LDL cholesterol, raises HDL, and reduces cardiovascular risk. Benefits include preventing heart attacks, strokes, and atherosclerosis, supporting long-term heart health, improving lipid profiles, and reducing morbidity and mortality from cardiovascular diseases.
Simvastatin tablets, marketed as Zocor, are approved in the US by the FDA and in the EU via EMA for managing hyperlipidemia and reducing cardiovascular risk. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. The FDA reviews detailed clinical trial and manufacturing data, while the EMA ensures compliance with regional safety and quality standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring regional adherence supports timely approval, safe use, and global availability of simvastatin tablets, helping patients worldwide prevent cardiovascular events and improve long-term heart health.