Celesterase 1,500iu
| Product Overview | |
| Generic Name | Celesterase 1,500iu |
| Brand Name(s) | Human C1-Esterase Inhibitor EP 500 IU |
| Form | Injection (vial) |
| Strength | 500 IU C1-esterase inhibitor |
| Therapeutic Class | C1-esterase inhibitor for hereditary angioedema |
| ATC Code | B06AC01 |
| Manufacturing & Regulatory | |
| Manufacturer | Intas Pharmaceuticals Ltd |
| Country | India |
| GMP Compliance | WHO-GMP certified facility |
| DMF/CEP | Not publicly available |
| COFEPRIS | Clave number to request |
| Free Sale Certificate | Yes |
| Logistics & Export | |
| MOQ | 10 Vials |
| Shelf Life | 24 Months |
| Storage | 2–8 °C, do not freeze |
| Incoterms | FOB Mumbai/Bangalore |
| Lead Time | 2–4 weeks after PO |
| Documentation | |
| Certificate of Analysis (COA) | Provided by manufacturer |
| SDS | Available on request |
| CTD Summary | Provided under NDA/purchase with fee |
Description
Indications & Usage: Used for prophylaxis and treatment of hereditary angioedema attacks. Binds/inhibits C1-esterase to reduce edema. Approved for treatment of acute abdominal, facial, or laryngeal hereditary angioedema (HAE) attacks in both adult and pediatric patients
