Denosumab-Bbdz Suppliers & Bulk Manufacturers
Available Forms: Injection for subcutaneous use
Available Strengths: 60 mg, 120 mg
Reference Brands: Prolia(US & EU); Jubbonti - biosimilar to Prolia
Category:
Biosimilars
Jubbonti, a biosimilar to Prolia (denosumab), blocks RANKL, inhibiting osteoclast formation and activity. It effectively treats osteoporosis and prevents bone fractures. Benefits include similar efficacy to Prolia, lower costs, increased access to osteoporosis therapy, and improved bone health and strength when used under medical supervision.
Denosumab-bbdz is available in Injection for subcutaneous use
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-bbdz 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-bbdz 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:
Jubbonti, a biosimilar to Prolia (denosumab), is regulated in the EU and US with dossiers demonstrating biosimilarity, safety, efficacy, and manufacturing quality according to GMP standards. In the US, FDA approval involves extensive comparability, clinical validation, and safety data. In the EU, CE marking certifies conformity with MDR standards for biosimilars. These biosimilars undergo validation, stability testing, and audits, supported by comprehensive documentation including biosimilarity data, clinical trial results, safety profiles, and manufacturing practices. For licensing procedures, approved dossiers, and 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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