Casirivimab + Imdevimab
| Product Overview | |
| Generic Name | Casirivimab + Imdevimab |
| Brand Name(s) | REGEN-COV, Ronapreve |
| Form | Vial Solution for IV infusion and/or SC injection |
| Strength | 600 mg/mL casirivimab and 60 mg/mL imdevimab |
| Therapeutic Class | Antiviral monoclonal antibodies |
| ATC Code | J06BD07 |
| Manufacturing & Regulatory | |
| Manufacturer | Cipla, Regerneron, Roche, |
| Country | USA, India |
| GMP Compliance | WHO-GMP certified |
| DMF/CEP | Not publicly disclosed |
| COFEPRIS | No confirmed Mexican Registro Sanitario or CNIS clave |
| Free Sale Certificate | Possible only if sourced via a jurisdiction where it remains authorized |
| Logistics & Export | |
| MOQ | 100 units |
| Shelf Life | 24 Months |
| Storage | 2–8 °C, protect from light |
| Incoterms | EXW |
| Lead Time | 21 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | Yes—standard for vaccines: batch CoA/lot release documentation |
| SDS | Upon Request, not publicly posted |
| CTD Summary | CTD available to regulators; summary available to qualified partners |
Description
Casirivimab–imdevimab is a dual neutralizing monoclonal antibody combination targeting non-overlapping epitopes on the SARS-CoV-2 spike RBD, designed to reduce viral escape. Roche India and Cipla provide the antibody cocktail across Pan-India, with medicine databases list Ronapreve as the brand. For Latin American Import, government approval must be issued.
