Table 1.
General description of the amikacin products studied
| Amikacin product | Form | Demonstrated pharmaceutical equivalencea | Batch | Manufacturer | Distributor |
|---|---|---|---|---|---|
| BMS (innovator) | 1 g in 4 ml | Not applicable | 99A106 | Grove, Ecuador | The manufacturer |
| 0.5 g in 2 ml | 00G030 05H091A |
Bristol-Myers Squibb, Ecuador | |||
| Carlon | 0.5 g in 2 ml | Yes | 111V0203 | Carlon, Colombia | The manufacturer |
| FormasG | 0.5 g in 2 ml | No | 02525 | Vitropharma, Colombia | Formas genericas farmaceuticas, Colombia |
| Gencol | 0.25 g in 2 ml | Yes | 0100 0200 |
Chalver, Colombia | The manufacturer |
| Genven | 0.5 g in 2 ml | No | 904037 | Leti for Genven, Venezuela | The manufacturer |
| Pisa | 0.5 g in 2 ml | Yes | 060865 011306 |
PiSa, Mexico | ECAR, Colombia |
| Quimicol | 0.5 g in 2 ml | No | 3780199 | Quimicol, Colombia | The manufacturer |
| Scalpi | 0.5 g in 2 ml | Yes | AK030072 | Farmionni-Lubelca, Colombia | Farmionni scalpi, Colombia |
| Serpharma | 0.25 g in 2 ml | No | AK020086 | Farmionni-Lubelca, Colombia | Serpharma, Colombia |
| 0.1 g in 2 ml | AK010172 | ||||
| Sigma (reference) | 1 g powder | Yes | 120K1643 | Sigma Chemical Co, USA | The manufacturer |
| Zokumey | 0.25 g in 2 ml | No | AK020035 | Farmionni-Lubelca, Colombia | Zokumey pharma, Colombia |
aThe pharmaceutical equivalence (same potency and concentration of the active ingredient) tested by microbiological assay was published elsewhere [8]