Darunavir + Cobicistat 800/150mg
Product Overview
| Generic Name | Darunavir + Cobicistat 800/150mg |
| Brand Name(s) | PREZCOBIX® /REZOLSTA® |
| Category | Antivirals - Antiretrovirals |
| Form | 30 Film-coated oral tablets |
| Strength | 800 mg darunavir / 150 mg cobicistat per tablet |
| Therapeutic Class | HIV protease inhibitor + pharmaco-enhancer (CYP3A inhibitor) |
| ATC Code | J05AR14 |
Manufacturing & Regulatory
| Manufacturer | Generic, Cipla |
| GMP Compliance | WHO-GMP |
| DMF/CEP | Type II |
| COFEPRIS | 010.000.6098.00 |
| Free Sale Certificate | Yes |
Logistics & Export
| MOQ | 5 pks |
| Shelf Life | 24 months |
| Storage | Store below 25°C Protect from moisture and light. Do not refrigerate or freeze. |
| Incoterms | EXW |
| Lead Time | 7 - 10 Business Days |
Documentation Available Upon Request
| Certificate of Analysis (PDF) | Supplied per batch upon request |
| SDS-Safety Data Sheet (PDF) | Standard MSDS for API and tablets available (Cobicistat and Darunavir – international standards) |
| CTD Summary (PDF) | Not publicly available as parallel traded molecule |
Special Notes
Indications & Usage: Darunavir–Cobicistat fixed-dose tablet is indicated for the treatment of HIV‑1 infection in adults and pediatric patients (≥40 kg). Darunavir, a protease inhibitor, blocks HIV protease to prevent viral replication; cobicistat enhances darunavir by inhibiting CYP3A metabolism. It is administered once daily with food in combination with other antiretroviral agents. This regimen supports high genetic barrier to resistance and is suitable for treatment-naïve and treatment-experienced patients without darunavir resistance–associated mutations