Sildenafil Citrate Tablets Generics - Manufacturers & Suppliers
(US & EU): Viagra, Revatio (for pulmonary hypertension)
| Product/Composition:- | Sildenafil Citrate tablets |
|---|---|
| Strength:- | 25 mg, 50 mg, 100 mg; For pulmonary: 20 mg, 40 mg, 60 mg, 80 mg |
| Form:- | Tablet |
| Reference Brands:- | (US & EU): Viagra, Revatio (for pulmonary hypertension) |
| MOQ | As per the manufacturer batch size |
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Sildenafil citrate inhibits phosphodiesterase type 5 (PDE5), enhancing nitric oxide effects and increasing blood flow to the penis. It effectively treats erectile dysfunction, improving sexual function and confidence. Benefits include rapid onset, ease of use, and improved quality of life for men with ED, supporting healthier intimate relationships
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.