Losartan Potassium tablet
Form: Tablet
Strength: 25 mg, 50 mg, 100 mg
Reference Brands: Cozaar(US & EU)
Category: Heart Disorder
Losartan tablets, marketed as Cozaar, are approved in the US by the FDA and in the EU via EMA for treating hypertension, protecting kidney function, and reducing cardiovascular events. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. The FDA reviews detailed clinical trial data and manufacturing processes, while the EMA ensures compliance with regional safety and quality regulations. For guidance on dossier preparation, regulatory pathways, and market strategies, visit PharmaTradz. Ensuring regulatory adherence supports timely approval, safe use, and global availability of losartan tablets, helping improve cardiovascular health outcomes worldwide.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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