Denosumab 60mg pfs
| Product Overview | |
| Generic Name | Denosumab 60mg pfs |
| Brand Name(s) | Prolia®, Xgeva®; biosimilars: |
| Form | Subcutaneous injection solution (prefilled syringe) |
| Strength | 60 mg in 1.0 mL |
| Therapeutic Class | RANKL inhibitor; bone density conservation agent |
| ATC Code | M05BX04 |
| Manufacturing & Regulatory | |
| Manufacturer | Amgen (originator); Intas |
| Country | India/USA/EU |
| GMP Compliance | WHO-GMP, must request certificate from manufacturer |
| DMF/CEP | Not publicly disclosed – request from manufacturer |
| COFEPRIS | 010.000.5613.00 |
| Free Sale Certificate | Yes, available as COPP/CPP |
| 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) | Supplied per batch 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.
