Glaxo Wellcome S/A is a finished-dose manufacturer based in Spain. It appears in 162 regulatory filings across 7 regulators, without an active US DMF or CEP on file. Its filings concentrate with ANVISA (Brazil), ARCSA (EC) and MINSA (CR). Its GMP standing is certified by MFDS (Korea), NAFDAC (NG) and EMA, among 5 authorities.
| Site | FDA FEI |
|---|---|
| Aranda De Duero(Burgos), United Arab Emirates | Not on file |
| Burgos, Spain | Not on file |
| ARANDA DE DUERO, Spain | Not on file |
| Aranda De Duero, Spain | Not on file |
| Regulator | Filings | GMP certificates |
|---|---|---|
| ANVISA (Brazil) | 129 | None |
| ARCSA (EC) | 13 | None |
| MINSA (CR) | 9 | None |
| INVIMA (CO) | 7 | None |
| NAFDAC (NG) | 2 | 1 |
| COFEPRIS (MX) | 1 | None |
| MFDS (Korea) | None | 2 |
| EMA | None | 1 |
| NCELS (KZ) | None | 1 |
| AEMPS (ES) | None | 1 |
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