Laronidase 2.9mg
| Product Overview | |
| Generic Name | Laronidase 2.9mg |
| Brand Name(s) | Aldurazyme® |
| Form | single use vial, Concentrate for solution for infusion |
| Strength | 2.9mg/5mL / 0.58 mg/mL |
| Therapeutic Class | recombinant human α-L-iduronidase |
| ATC Code | A16AB05 |
| Manufacturing & Regulatory | |
| Manufacturer | BioMarin, Genzyme |
| Country | USA, Netherlands |
| GMP Compliance | WHO-GMP |
| COFEPRIS | 010.000.5547.00.00 |
| Free Sale Certificate | Yes, available as COPP/CPP |
| Logistics & Export | |
| MOQ | 5 units |
| Shelf Life | 36 months |
| Storage | 2–8 °C, protect from light |
| Incoterms | EXW, HS 30049091 |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | Supplied per batch upon request |
| CTD Summary | Not publicly available as parallel traded molecule |
Description
Laronidase is a recombinant α-L-iduronidase enzyme replacement therapy indicated for long-term treatment of patients with confirmed mucopolysaccharidosis I / MPS I to address the non-neurological manifestations of disease. It is used in Hurler and Hurler-Scheie forms and in Scheie patients with moderate to severe symptoms
