Tirzepatide 5mg
| Product Overview | |
| Generic Name | Tirzepatide 5mg |
| Brand Name(s) | Mounjaro, Zepbound |
| Form | PFS, (prefilled syringe pen) |
| Strength | 5 mg. / 0.5 mL (also available in 2.5 mg, 7.5 mg, 10 mg, 12.5 mg & 15 mg. All in 0.5 mL) |
| Therapeutic Class | Dual GIP–GLP-1 receptor agonist for T2DM, obesity, and sleep apnea |
| ATC Code | A10BK04 |
| Manufacturing & Regulatory | |
| Manufacturer | Eli Lilly; API also sourced from Indian CDMOs |
| Country | India |
| GMP Compliance | WHO-GMP, API mfgs hold ISO/FDA certificates |
| DMF/CEP | DMFs via API suppliers (Type II) |
| COFEPRIS | Under Registration (2025) |
| Free Sale Certificate | Yes |
| Logistics & Export | |
| MOQ | 100 units |
| Shelf Life | 24 Months |
| Storage | Refrigerated (2–8 °C) |
| Incoterms | FOB / CIF / DDP |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | Yes |
| SDS | Upon Request |
| CTD Summary | Full CTD (eCTD) available from distribution partners |
Description
INDICATION and USAGE: Once-weekly injection for type 2 diabetes (as Mounjaro); obesity management and OSA (as Zepbound).
Demonstrates marked reductions in HbA1c and weight (~15–20%) with favorable safety profile
