Dapoxetine Tablets Suppliers & Bulk Manufacturers

Available Forms: Tablet

Available Strengths: 30 mg and 60 mg t

Reference Brands: Priligy(US & EU)

Category: Sexual Wellness

Dapoxetine tablets is available in Tablet and strengths such as 30 mg and 60 mg t. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Dapoxetine tablets is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

Dapoxetine tablets can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.

Product Description: Dapoxetine tablets, marketed as Priligy, are approved in the EU for premature ejaculation but are not approved in the US by the FDA. Regulatory approval in the EU requires a detailed dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. The US FDA has not granted approval, citing insufficient data. For guidance on dossier preparation, regulatory pathways, and market access strategies, visit PharmaTradz. Ensuring compliance with regional requirements is essential for timely approval, safe use, and global availability, supporting men’s sexual health and confidence worldwide. Proper documentation and adherence to regional standards are crucial for successful market entry and regulatory approval in Europe.