Zoledronic Acid 4 mg / 5 mL
| Product Overview | |
| Generic Name | Zoledronic Acid 4 mg / 5 mL |
| Brand Name(s) | Zometa® |
| Form | 4 mg/5 mL single-use vial/ampoule |
| Strength | 4 mg |
| Therapeutic Class | Bisphosphonate; bone-resorption inhibitor; regulator of bone metabolism; antiresorptive agent |
| ATC Code | M05BA08 |
| Manufacturing & Regulatory | |
| Manufacturer | Novartis, Intas, Natco |
| Country | Mexico, Canada, India |
| GMP Compliance | WHO-GMP |
| COFEPRIS | 010.000.5468.00 |
| Free Sale Certificate | Yes, available as COPP/CPP |
| Logistics & Export | |
| MOQ | 10 boxes |
| Shelf Life | 36 months |
| Storage | unopened vial has no special storage conditions |
| Incoterms | EXW, HS 30049099 |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | Provided per batch |
| CTD Summary | CTD proprietary; available under commercial agreement/license |
Description
Zoledronic Acid 4 mg/5 mL is an intravenous bisphosphonate used primarily in oncology-supportive care to inhibit osteoclast-mediated bone resorption. It is indicated for prevention of skeletal-related events in adult patients with advanced malignancies involving bone, including bone metastases and multiple myeloma, and for treatment of tumour-induced hypercalcaemia. Zoledronic Acid / Ácido zoledrónico: unopened vial has no special storage conditions; after dilution, use immediately or generally not longer than 24 hours at 2–8°C
