Product/Composition:- | Bempedoic Acid tablets |
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Strength:- | 180 mg |
Form:- | Tablet |
Reference Brands:- | Nexletol(US & EU) |
MOQ | As per the manufacturer batch size |
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Bempedoic acid inhibits ATP citrate lyase, reducing cholesterol synthesis in the liver. It lowers LDL cholesterol levels, decreasing cardiovascular risk. Benefits include effective LDL reduction, fewer side effects compared to statins, and support for patients intolerant to statins, aiding long-term lipid management and cardiovascular disease prevention
Bempedoic acid tablets, marketed as Nexletol, are approved in the US by the FDA and in the EU via EMA for adults with hyperlipidemia or atherosclerotic cardiovascular disease. Regulatory approval requires comprehensive dossiers including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews detailed trial data and manufacturing processes, while the EMA ensures compliance with regional safety and quality standards. For guidance on dossier submission, regulatory pathways, and market access, visit PharmaTradz. Ensuring compliance supports timely approval, safe use, and global availability of bempedoic acid tablets, helping improve lipid management and cardiovascular outcomes worldwide.