Sildenafil Citrate tablets

Form: Tablet

Strength: 25 mg, 50 mg, 100 mg; For pulmonary: 20 mg, 40 mg, 60 mg, 80 mg

Reference Brands: (US & EU): Viagra, Revatio (for pulmonary hypertension)

Category: Sexual Wellness

Sildenafil citrate tablets, marketed as Viagra and Revatio, are approved in the US by the FDA and in the EU via EMA for erectile dysfunction and pulmonary hypertension, respectively. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, FDA review involves detailed clinical and quality assessments, while the EMA ensures compliance with regional safety and manufacturing regulations. 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 patients worldwide in managing ED and pulmonary hypertension effectively.