Product/Composition:- | Alprostadil injection |
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Strength:- | 10 µg and 20 µg |
Form:- | powder for injection |
Reference Brands:- | Caverject, Edex(US) |
MOQ | As per the manufacturer batch size |
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Alprostadil injection relaxes smooth muscle by acting as a prostaglandin E1 agonist, increasing blood flow to the penis for an erection. It provides rapid onset, reliable results, and effective treatment for erectile dysfunction, especially in cases unresponsive to oral medications, supporting better sexual performance and confidence.
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.