Galderma is a finished-dose manufacturer based in Brazil. It appears in 807 regulatory filings across 30 regulators, without an active US DMF or CEP on file. Its filings concentrate with EMA, AIFA (IT) and ANVISA (Brazil). Its GMP standing is certified by ANVISA (Brazil), HSA (SG) and ANSM (FR), among 4 authorities.
| Site | FDA FEI |
|---|---|
| HORTOLANDIA, Brazil | Not on file |
| Zug, Switzerland | Not on file |
| Hortolandia, Colombia | Not on file |
| BIOT, France | Not on file |
| LEGANÉS, Portugal | Not on file |
| Alcochete, Portugal | Not on file |
| Regulator | Filings | GMP certificates |
|---|---|---|
| EMA | 128 | None |
| AIFA (IT) | 80 | None |
| ANVISA (Brazil) | 75 | 3 |
| MHRA (UK) | 69 | None |
| Health Canada | 68 | None |
| INHRR (VE) | 58 | None |
| HSA (SG) | None | 2 |
| ANSM (FR) | None | 2 |
| INVIMA (CO) | None | 1 |
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