Hydroxyurea Capsule Suppliers & Bulk Manufacturers

Available Forms: Capsules

Available Strengths: 500 mg, 1000 mg

Reference Brands: Droxia(US); Hydrea(US & EU)

Category: Blood Disorder

Hydroxyurea Capsule is available in Capsules and strengths such as 500 mg, 1000 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, Hydroxyurea Capsule is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

Hydroxyurea Capsule 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: Hydroxyurea capsules, marketed as Hydrea and Hydroxycarbamide, are approved by the FDA in the US and EMA in the EU for sickle cell anemia and certain cancers. Regulatory approval requires a detailed dossier including clinical trial data, manufacturing standards, safety, efficacy, and pharmacovigilance plans. In the US, submission to the FDA involves comprehensive review processes, while the EU mandates adherence to regional quality and safety guidelines. For expert guidance on dossier preparation, regulatory pathways, and successful market entry strategies, visit PharmaTradz. Ensuring compliance with regional regulations is crucial for the approval, safe use, and global commercialization of hydroxyurea capsules.