REZOLSTA® (darunavir + cobicistat) 800/150mg
Product Overview
| Generic Name | REZOLSTA® (darunavir + cobicistat) 800/150mg |
| Brand Name(s) | PREZCOBIX® (US), Rezolsta® (EU) |
| 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 | Janssen Products, LP (J&J) |
| GMP Compliance | WHO-GMP |
| DMF/CEP | Type II |
| COFEPRIS | 010.000.6098.00 / 427M2016 SSA |
| Free Sale Certificate | Yes, available as COPP/CPP |
Logistics & Export
| MOQ | 10 pks |
| Shelf Life | 24 months |
| Storage | Store below 25°C Protect from moisture and light. Do not refrigerate or freeze. |
| Incoterms | EXW/FOB/CIF negotiable |
| Lead Time | 7 - 10 Business Days |
Documentation Available Upon Request
| Certificate of Analysis (PDF) | Provided per batch |
| SDS-Safety Data Sheet (PDF) | Standard MSDS for API and tablets available (Cobicistat and Darunavir – international standards) |
| CTD Summary (PDF) | Yes (public summaries): EMA SmPC & EPAR provide CTD-style |
Special Notes
REZOLSTA® / PREZCOBIX®: (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