Alprostadil injection

Form: powder for injection

Strength: 10 µg and 20 µg

Reference Brands: Caverject, Edex(US)

Category: Sexual Wellness

Alprostadil injection, marketed as Caverject and Edex, is approved in the US by the FDA and in the EU via EMA for erectile dysfunction treatment. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews detailed 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 thorough regulatory compliance is essential for timely approval, safe use, and global availability of alprostadil injection, supporting effective ED management and improved patient outcomes worldwide.