Denosumab Suppliers & Bulk Manufacturers
Available Forms: Subcutaneous injection
Available Strengths: subcutaneous injection
Reference Brands: Xgeva; Wyost - biosimilar to Xgeva
Category:
Biosimilars
Wyost, a biosimilar to Xgeva (denosumab), inhibits RANKL, reducing osteoclast formation and activity. It prevents bone loss, fractures, and skeletal-related events in cancer patients with bone metastases and osteoporosis. Benefits include similar efficacy to Xgeva, lower costs, and increased patient access to bone health treatments when used under medical guidance.
Denosumab is available in Subcutaneous injection
and strengths such as subcutaneous injection.
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, Denosumab 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) |
Denosumab 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:
Wyost, a biosimilar to Xgeva (denosumab), is regulated in the EU and US with dossiers demonstrating biosimilarity, safety, efficacy, and manufacturing quality in compliance with GMP standards. In the US, FDA approval requires extensive comparability data and validation, while in the EU, CE marking certifies conformity with MDR standards. These biosimilars undergo validation, stability testing, and audits, supported by comprehensive documentation including biosimilarity, clinical trial data, safety profiles, and manufacturing practices. For licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to affordable, high-quality denosumab biosimilars for osteoporosis and bone metastases treatment worldwide.
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