Avanafil tablets

Form: Tablet

Strength: 50 mg, 100 mg, 200 mg

Reference Brands: Stendra(US)

Category: Sexual Wellness

Avanafil tablets, marketed as Stendra, are approved in the US by the FDA and in the EU via EMA for erectile dysfunction. Regulatory approval requires detailed dossiers including clinical trial data, safety profiles, manufacturing standards, and pharmacovigilance plans. In the US, FDA reviews clinical efficacy and quality data, while the EMA ensures compliance with regional safety and manufacturing standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring compliance is vital for timely approval, safe use, and global availability of avanafil tablets, supporting effective management of erectile dysfunction worldwide and enhancing patient confidence.