Tadalafil tablets

Form: Tablet

Strength: 2.5 mg, 5 mg, 10 mg, 20 mg and 40 mg(P. Hypertension)

Reference Brands: Cialis(US & EU),Adcirca(US)

Category: Sexual Wellness

Tadalafil tablets, marketed as Cialis, are approved in the US by the FDA and in the EU via EMA for erectile dysfunction (ED) and benign prostatic hyperplasia (BPH). 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 manufacturing data, while the EMA ensures compliance with regional safety and quality standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring regulatory compliance is essential for timely approval, safe use, and global availability, supporting millions of men in managing ED and BPH effectively worldwide.