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 inhibits DNA synthesis by blocking ribonucleotide reductase, reducing proliferation of abnormal cells. It increases fetal hemoglobin production, alleviating sickle cell symptoms, and reduces tumor growth in certain cancers. Benefits include improved quality of life, fewer sickling crises, and enhanced disease management in sickle cell anemia and specific malignancies.
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.
|
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) |
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.
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