
Aliskiren tablets
Form: Tablets
Strength: 150 mg, 300 mg
Reference Brands: Tekturna(US & EU)
Category: Heart Disorder
Aliskiren tablets, marketed as Tekturna, are approved in the US by the FDA and in the EU via EMA for hypertension management. 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 safety data, while the EMA ensures regional safety and manufacturing compliance. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence to regional regulations supports timely approval, safe use, and worldwide availability of aliskiren tablets, helping improve blood pressure control and reduce cardiovascular risks globally.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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