Denosumab 120mg
| Product Overview | |
| Generic Name | Denosumab 120mg |
| Brand Name(s) | Prolia®, Xgeva®; biosimilars: Jubbonti®, Wyost®, |
| Form | Subcutaneous injection solution (prefilled syringe or vial) |
| Strength | 120 mg |
| Therapeutic Class | RANKL inhibitor; bone density conservation agent |
| ATC Code | M05BX04 |
| Manufacturing & Regulatory | |
| Manufacturer | Amgen (originator) Intas Pharmaceuticals |
| Country | India/USA/EU |
| GMP Compliance | WHO/cGMP-compliant |
| DMF/CEP | Type II |
| COFEPRIS | Not found in public COFEPRIS database |
| Free Sale Certificate | Available from supplier on request |
| Logistics & Export | |
| MOQ | 5 units |
| Shelf Life | 24 Months |
| Storage | Refrigerated 2–8 °C; bring to room temp before use |
| Incoterms | EXW/FOB/CIF negotiable |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | available from manufacturer upon request |
| SDS | available from manufacturer/distributor |
| CTD Summary | proprietary; may be available upon commercial commitment/documentation fee |
Description
Denosumab is a human monoclonal antibody indicated for the treatment of osteoporosis in postmenopausal women and men at high risk of fracture, bone loss due to hormone ablation in cancer, and for prevention of skeletal-related events in patients with bone metastases from solid tumors. It works by inhibiting RANKL, thereby reducing bone resorption.
