Dolutegravir 50 mg
Product Overview
| Generic Name | Dolutegravir 50 mg |
| Brand Name(s) | Tivicay® (GSK), Instgra™ (Emcure) |
| Category | Antivirals - Antiretrovirals |
| Form | Film‑coated oral tablets |
| Strength | 50 mg per tablet |
| Therapeutic Class | Integrase strand transfer inhibitor (INSTI) |
| ATC Code | J05AX12 |
Manufacturing & Regulatory
| Manufacturer | GlaxoSmithKline (Tivicay), Emcure Pharmaceuticals (Instgra), various Indian generic makers |
| GMP Compliance | WHO‑GMP-certified |
| DMF/CEP | Type II |
| COFEPRIS | Pending |
| Free Sale Certificate | Yes |
Logistics & Export
| MOQ | 10 pks |
| Shelf Life | 24 Months |
| Storage | Store below 30°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) | Available from manufacturer |
| CTD Summary (PDF) | Upon Request |
Special Notes
Indications & Usage: Dolutegravir is a potent integrase strand transfer inhibitor indicated for treating HIV‑1 infection in adults and children weighing ≥30 kg, used in combination antiretroviral therapy. It has a high genetic barrier to resistance and is favored for once-daily dosing, with or without food. It requires monitoring in pregnancy (neural-tube defect concerns), renal, and hepatic impairment