Testosterone Gel

Form: topical application/ gel

Strength: 20.25 mg, 40.5 mg, or 50 mg

Reference Brands: AndroGel, Testim, Axiron(US)

Category: Sexual Wellness

Testosterone gel, marketed as AndroGel and Testim, is approved in the US by the FDA and in the EU via EMA for hormone replacement therapy in testosterone deficiency. Regulatory approval requires a detailed dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews comprehensive clinical and quality data, while the EMA ensures compliance with regional safety and manufacturing regulations. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring regional compliance is essential for timely approval, safe use, and worldwide availability, supporting men's health worldwide and improving symptom management in testosterone deficiency.