Phyton Biotech
Germany Updated 9 July 2026
Phyton Biotech is a contract manufacturer based in Germany. It holds 2 active US drug master files and 3 valid CEPs across a filed portfolio of 2 molecules. Its GMP standing is certified by ZLG (DE) and US FDA. Its most recent recorded inspection, by US FDA, closed on 19 October 2024 as VAI.
4
registered plants
2 with an FDA FEI number
0
filings
across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.
Inspection history
- 19 October 2024 VAI US FDA
- 29 March 2023 VAI US FDA
- 20 February 2020 VAI US FDA
- 28 August 2019 NAI US FDA
- 15 September 2017 NAI US FDA
- 15 July 2016 VAI US FDA
- 24 October 2014 VAI US FDA
- 27 September 2013 VAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| Delta, Canada | Not on file |
| Canada, Canada | 3006110823 |
| Ahrensburg, Germany | Not on file |
| Germany, Germany | 3002807883 |
What they file, and where
| Molecule | Regulators | Docs |
| Docetaxel | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Paclitaxel | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
Also appears on these molecule pages
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| ZLG (DE) | None | 4 |
| US FDA | None | 1 |
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Open risk flags
- The most recent inspection outcome was VAI, on 19 October 2024.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates