Meiji Seika Pharma is a finished-dose manufacturer based in Japan. It holds 2 active US drug master files and 2 valid CEPs across a filed portfolio of 2 molecules. Its filings concentrate with AEMPS (ES), INFARMED (PT) and EMA. Its GMP standing is certified by EMA and AEMPS (ES). Its most recent recorded inspection, by US FDA, closed on 2 September 2022 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Madrid, Spain | Not on file |
| Alcala De Henares, Spain | Not on file |
| Tokyo, Japan | Not on file |
| Japan, Japan | 3008927877 |
| Japan, Japan | 3002902776 |
| ALCALA DE HENARES, Portugal | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Daunorubicin | EDQM, US FDA | 2 |
| Doxorubicin | EDQM, US FDA | 2 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| AEMPS (ES) | 40 | 1 |
| INFARMED (PT) | 17 | None |
| EMA | 12 | 1 |
| DIGEMAPS (DO) | 8 | None |
| ARCSA (EC) | 6 | None |
| DAV (Vietnam) | 5 | None |
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