Product/Composition:- | Ezetimibe tablet |
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Strength:- | 10 mg |
Form:- | Tablet |
Reference Brands:- | Zetia(US), Ezetrol(EU) |
MOQ | As per the manufacturer batch size |
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Ezetimibe inhibits intestinal absorption of dietary and biliary cholesterol by blocking the NPC1L1 transporter. It significantly lowers LDL cholesterol, supports cardiovascular health, and reduces atherosclerosis risk. Benefits include effective cholesterol management, often combined with statins for enhanced lipid lowering and improved long-term heart health outcomes.
Ezetimibe tablets, marketed as Zetia in the US and Ezetrol in the EU, are approved for lowering LDL cholesterol by inhibiting intestinal absorption. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews detailed clinical trial and quality information, while the EMA ensures compliance with regional safety and manufacturing standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence to regional regulations supports timely approval, safe use, and global availability, enabling effective lipid management and cardiovascular risk reduction worldwide.