Medichem is an API and finished-dose manufacturer based in Spain. It holds 27 active US drug master files. Its filings concentrate with DAV (Vietnam), FDA (GH) and AEMPS (ES). Its GMP standing is certified by EMA, AEMPS (ES) and US FDA. Its most recent recorded inspection, by US FDA, closed on 22 June 2023 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Gerona, Spain | Not on file |
| Barcelona, Spain | Not on file |
| Girona, Spain | Not on file |
| Spain, Spain | 3002807552 |
| Molecule | Regulators | Docs |
|---|---|---|
| Chlorhexidine | US FDA | 4 |
| Brimonidine | SFDA (Saudi Arabia), US FDA | 3 |
| Quetiapine | SFDA (Saudi Arabia), US FDA | 3 |
| Cyclobenzaprine | SFDA (Saudi Arabia), US FDA | 2 |
| Loxapine | US FDA | 2 |
| Adapalene | US FDA | 1 |
| Amoxapine | US FDA | 1 |
| Auranofin | PMDA (Japan) | 1 |
| Captopril | US FDA | 1 |
| Cinacalcet | SFDA (Saudi Arabia) | 1 |
| Clozapine | US FDA | 1 |
| Felodipine | US FDA | 1 |
| Fluvoxamine | US FDA | 1 |
| Guanfacine | US FDA | 1 |
| Ivacaftor | US FDA | 1 |
| Lamotrigine | US FDA | 1 |
| Mexiletine | US FDA | 1 |
| Mirtazapine | US FDA | 1 |
| Nepafenac | US FDA | 1 |
| Paroxetine | US FDA | 1 |
| Pazopanib | US FDA | 1 |
| Pimecrolimus | US FDA | 1 |
| Probucol | PMDA (Japan) | 1 |
| Sunitinib Malate | SFDA (Saudi Arabia) | 1 |
| Tamsulosin | US FDA | 1 |
| Varenicline | US FDA | 1 |
| Varenicline Tartarate | SFDA (Saudi Arabia) | 1 |
| Vildagliptin | SFDA (Saudi Arabia) | 1 |
| Voclosporin | US FDA | 1 |
| マレイン酸エナラプリル | PMDA (Japan) | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| DAV (Vietnam) | 50 | None |
| FDA (GH) | 11 | None |
| AEMPS (ES) | 6 | 2 |
| EMA | 5 | 2 |
| INFARMED (PT) | 4 | None |
| MINSA (CR) | 2 | None |
| US FDA | None | 1 |
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