Bempedoic Acid tablets
Form: Tablet
Strength: 180 mg
Reference Brands: Nexletol(US & EU)
Category: Heart Disorder
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.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Related Products
Aliskiren tablets
Strength: 150 mg, 300 mg
Form: Tablets
Reference Brands: Tekturna(US & EU)
View Details Get Enquiry
Atenolol tablets
Strength: 25 mg, 50 mg, 100 mg
Form: Tablets
Reference Brands: Tenormin(US)
View Details Get Enquiry
Metoprolol Tartrate tablet
Strength: IR: 25 mg, 50 mg, 100 mg; ER: 25 mg, 50 mg, 100 mg, 200 mg
Form: Tablets(IR & ER)
Reference Brands: US: Lopressor(IR); Toprol-XL(ER)
View Details Get Enquiry
Nifedipine tablets(IR/ER)
Strength: 10 mg, 20 mg, 30 mg, 60 mg, 90 mg (IR and ER forms)
Form: Tablet(IR & ER)
Reference Brands: Procardia(US);
View Details Get Enquiry