Basf Se is an API manufacturer based in Germany. It holds 2 active US drug master files and 14 valid CEPs across a filed portfolio of 13 molecules. Its filings concentrate with EFDA (ET) and MINSA (CR). Its GMP standing is certified by ZLG (DE), EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 29 August 2024 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Germany, Germany | 3002903906 |
| Ludwigshafen, Germany | Not on file |
| Rhineland-Palatinate, Germany | Not on file |
| Ludwigshafen Am Rhein, Germany | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Levomenthol | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Dexpanthenol | EDQM, SFDA (Saudi Arabia) | 2 |
| Povidone | EDQM | 2 |
| Povidone-Iodine | EDQM, US FDA | 2 |
| Calcium Pantothenate | EDQM | 1 |
| Copovidone | EDQM | 1 |
| Crospovidone | EDQM | 1 |
| Dl-Alpha Tocopheryl Acetate | EDQM | 1 |
| Dl-Alpha-Tocopherol | EDQM | 1 |
| Ibuprofen | EDQM | 1 |
| Phenoxyethanol | EDQM | 1 |
| Riboflavin | EDQM | 1 |
| Vitamin A | EDQM | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| EFDA (ET) | 1 | None |
| MINSA (CR) | 1 | None |
| ZLG (DE) | None | 6 |
| EMA | None | 2 |
| US FDA | None | 1 |
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