Chemische Fabrik Berg is a contract manufacturer based in Germany. It holds 5 active US drug master files and 10 valid CEPs across a filed portfolio of 14 molecules. Its GMP standing is certified by ZLG (DE) and US FDA. Its most recent recorded inspection, by US FDA, closed on 16 May 2024 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Germany, Germany | 3003004618 |
| Bitterfeld-Wolfen, Germany | Not on file |
| Bitterfeld Wolfen, Germany | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Dimenhydrinate | EDQM, SFDA (Saudi Arabia) | 2 |
| Doxazosin Mesilate | EDQM | 2 |
| Tamoxifen Citrate | EDQM | 2 |
| Butalbital | US FDA | 1 |
| Fluorouracil | SFDA (Saudi Arabia) | 1 |
| Hydroxyzine | US FDA | 1 |
| Methenamine | US FDA | 1 |
| Pentobarbital | EDQM | 1 |
| Phenobarbital | EDQM | 1 |
| Phentermine | US FDA | 1 |
| Propylthiouracil | US FDA | 1 |
| Terazosin | EDQM | 1 |
| Thiopental Sodium And Sodium Carbonate | EDQM | 1 |
| Xylometazoline | EDQM | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| ZLG (DE) | None | 4 |
| US FDA | None | 1 |
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