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