Lundbeck Pharmaceuticals Italy is a contract manufacturer based in Italy. It holds 8 active US drug master files and one valid CEP across a filed portfolio of 8 molecules. Its most recent recorded inspection, by US FDA, closed on 25 March 2022 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Padova, Italy | Not on file |
| Italy, Italy | 3002808449 |
| Molecule | Regulators | Docs |
|---|---|---|
| Trimipramine | EDQM, US FDA | 2 |
| (21R)-Argatroban | US FDA | 1 |
| Clomipramine | US FDA | 1 |
| Dapsone | US FDA | 1 |
| Desipramine | US FDA | 1 |
| Diazoxide | US FDA | 1 |
| Imipramine | US FDA | 1 |
| Metoclopramide | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MPA (SE) | 1 | None |
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