PX-0915A, Insulin Glargine /recombinant human insulin analog
| Product Overview | |
| Generic Name | PX-0915A, Insulin Glargine /recombinant human insulin analog |
| Brand Name(s) | Lantus, Basaglar, Insolenta, Glargix-G |
| Form | 10 mL multi-dose |
| Strength | 100 units/mL |
| Therapeutic Class | Antidiabetic (basal insulin); manage type 1 & type 2 diabetes |
| ATC Code | A10AE04 |
| Manufacturing & Regulatory | |
| Manufacturer | Pan Am Farma |
| Country | Mexico |
| GMP Compliance | WHO/cGMP-compliant |
| DMF/CEP | proprietary; |
| COFEPRIS | Pending |
| Free Sale Certificate | Yes |
| Logistics & Export | |
| MOQ | 100 units |
| Shelf Life | 24 Months |
| Storage | Refrigerated 2–8 °C; after opening/store at room temp up to 28 days |
| Incoterms | EXW/FOB/CIF negotiable |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | provided by manufacturer/distributor |
| SDS | Upon Request |
| CTD Summary | Full CTD dossier proprietary; available under commercial agreement/license |
Description
Indication & Usage: Long‑acting synthetic insulin analog indicated for basal glycemic control in type 1 and type 2 diabetes. Administered once daily subcutaneously; not for diabetic ketoacidosis. Should not be mixed/diluted with other insulins due to acidic pH. Provide stable, peak‑less insulin level over ~24 hours
