Denosumab 60mg pfs
| Product Overview | |
| Generic Name | Denosumab 60mg pfs |
| Brand Name(s) | Prolia®, Xgeva®; biosimilars: Jubbonti®, Wyost®, Ospomyv, Stoboclo |
| Form | Subcutaneous injection solution (prefilled syringe or vial) |
| Strength | 60 mg/mL |
| Therapeutic Class | RANKL inhibitor; bone density conservation agent |
| ATC Code | M05BX04 |
| Manufacturing & Regulatory | |
| Manufacturer | Amgen (originator); Indian manufacturers Intas Pharmaceuticals |
| Country | India/USA/EU |
| GMP Compliance | WHO-GMP, must request certificate from manufacturer |
| DMF/CEP | Not publicly disclosed – request from manufacturer |
| COFEPRIS | Not found in public COFEPRIS database |
| Free Sale Certificate | Yes |
| 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 — type standard for injectable biologic |
| 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.
