
Fenofibrate Caplets and Capsules
Form: Caplets and Capsules
Strength: 67 mg, 135 mg, 160 mg, and 145 mg
Reference Brands: Tricor(US), Fenogal, Lipanor(EU)
Category: Heart Disorder
Fenofibrate caplets and capsules, marketed as Tricor in the US and as Fenogal or Lipanor in the EU, are approved for managing hypertriglyceridemia and hypercholesterolemia. Regulatory approval requires a detailed dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews comprehensive clinical trial and quality information, while the EU’s EMA ensures compliance with regional safety and manufacturing regulations. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring regional regulatory adherence supports timely approval, safe use, and worldwide availability of fenofibrate capsules, promoting cardiovascular health and lipid management globally.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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