Insulin Glargine (Biosimilar) 10ml U-100
| Product Overview | |
| Generic Name | Insulin Glargine (Biosimilar) 10ml U-100 |
| Brand Name(s) | Basalog, Insolenta, PX-0915A, Basaglar, Lantus |
| Form | Vial |
| Strength | 100 IU\mL |
| Therapeutic Class | Antidiabetic agent; long‑acting insulin analogue |
| ATC Code | A10AE04 |
| Manufacturing & Regulatory | |
| Manufacturer | Pan Am Farma |
| Country | Mexico |
| GMP Compliance | WHO-GMP, EU-GMP |
| DMF/CEP | 27581 |
| COFEPRIS | Under Registration (2025) |
| Free Sale Certificate | Available per batch upon request |
| Logistics & Export | |
| MOQ | 5,000 units |
| Shelf Life | 24 Months |
| Storage | 2–8 °C in fridge; do not freeze; |
| Incoterms | Ex-Works Mexico |
| Lead Time | 4 weeks |
| Documentation | |
| Certificate of Analysis (COA) | Manufacturer provides COA |
| SDS | Available from manufacturer |
| CTD Summary | CTD available to regulators; summary available to qualified partners |
Description
Indications & Usage: Once-daily basal insulin to improve glycemic control in adults and children (>2 yrs) with type 1 or type2 diabetes mellitus.
Current Status of the Product
Our glargine formulation was developed and manufactured in alignment with WHO standards and was originally produced specifically for Mexican Government hospital tenders. At this time:
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The product is not yet formally registered in any Latin American country outside of Mexico.
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Our multi-country registration program for Latin America is underway but has not concluded.
Accordingly, we are not yet able to offer Insolenta as a fully registered product within the region.
