PharmaZell is an API manufacturer based in Germany. It holds 7 active US drug master files and 12 valid CEPs across a filed portfolio of 15 molecules. Its GMP standing is certified by ZLG (DE) and EMA. Its most recent recorded inspection, by US FDA, closed on 30 June 2022 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Raubling, Germany | Not on file |
| Germany, Germany | 3003725792 |
| Molecule | Regulators | Docs |
|---|---|---|
| Mesalazine | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Acetylcysteine | EDQM, US FDA | 2 |
| Cholic Acid | EDQM, US FDA | 2 |
| Propafenone | EDQM, US FDA | 2 |
| Teriflunomide | EDQM, US FDA | 2 |
| Ursodeoxycholic Acid | EDQM, US FDA | 2 |
| Balsalazide | US FDA | 1 |
| Carbocisteine | EDQM | 1 |
| Celecoxib | EDQM | 1 |
| Cysteine | EDQM | 1 |
| Cystine | EDQM | 1 |
| Etoricoxib | SFDA (Saudi Arabia) | 1 |
| Guanfacine | SFDA (Saudi Arabia) | 1 |
| Indapamide | EDQM | 1 |
| Methylene Blue | EDQM | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| ZLG (DE) | None | 6 |
| EMA | None | 2 |
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