Denosumab(Others Approved) Suppliers & Bulk Manufacturers
Available Forms: Subcutaneous injection
Available Strengths: 60 mg, 120 mg
Reference Brands: Xgeva(US & EU) Ospomyv, Xbryk, Merilog, Stoboclo, Zadenvi, Enwylma, Denbrayce, Izamby - biosimilar to Xgeva
Category:
Biosimilars
Biosimilars of Xgeva (denosumab) inhibit RANKL, preventing osteoclast formation and activity. They reduce bone destruction, fractures, and skeletal-related events in cancer and osteoporosis patients. Benefits include similar efficacy, lower costs, increased treatment access, and support for patient bone health when used under medical supervision.
Denosumab(Others approved) is available in Subcutaneous injection
and strengths such as 60 mg, 120 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, Denosumab(Others approved) 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(Others approved) 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:
Biosimilars of Xgeva (denosumab) are regulated in the EU and US, supported by dossiers demonstrating biosimilarity, safety, efficacy, and manufacturing quality in compliance with GMP standards. In the US, FDA approval involves extensive comparison, clinical validation, and safety data. In the EU, CE marking certifies conformity under the MDR. 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, supporting osteoporosis and bone metastasis treatment worldwide.
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