
Testosterone Gel Suppliers & Bulk Manufacturers
Available Forms: topical application/ gel
Available Strengths: 20.25 mg, 40.5 mg, or 50 mg
Reference Brands: AndroGel, Testim, Axiron(US)
Category: Sexual Wellness
Testosterone Gel is available in topical application/ gel and strengths such as 20.25 mg, 40.5 mg, or 50 mg. 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, Testosterone Gel is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.
Technical Specifications & Supply Details | |
---|---|
Lead Time | 7 to 60 days (depending on batch size & schedule) |
MOQ | As per manufacturer’s batch size |
COA | Available with every batch |
Regulatory Dossier / DMF | Available upon request |
Export Documentation | FSC, COA, Manufacturing License, Product Permission |
Standards | IP, BP, USP |
Certifications | WHO-GMP, EU-GMP, USFDA (as applicable) |
Testosterone Gel 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.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Product Description: 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.
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