Bipso
Germany 82 employees Updated 9 July 2026
Bipso is a finished-dose manufacturer based in Germany. It appears in 4 regulatory filings across 2 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC) and NCELS (KZ). Its GMP standing is certified by ZLG (DE), MFDS (Korea) and ANVISA (Brazil), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 4 May 2022 as VAI.
3
registered plants
1 with an FDA FEI number
4
filings
across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.
Inspection history
- 4 May 2022 VAI US FDA
- 7 November 2019 VAI US FDA
- 17 June 2016 NAI US FDA
- 11 February 2014 NAI US FDA
- 10 May 2012 NAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| SINGEN, Germany | Not on file |
| Germany, Germany | 3009099058 |
| Singen (Hohentwiel), Germany | Not on file |
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| ARCSA (EC) | 2 | None |
| NCELS (KZ) | 2 | None |
| ZLG (DE) | None | 6 |
| MFDS (Korea) | None | 2 |
| ANVISA (Brazil) | None | 1 |
| EMA | None | 1 |
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Open risk flags
- The most recent inspection outcome was VAI, on 4 May 2022.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates