Sever Pharma Solutions AB
Sweden 262 employees Updated 9 July 2026
Sever Pharma Solutions AB is a finished-dose manufacturer based in Sweden. It appears in 5 regulatory filings across 3 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC), NPRA (MY) and MINSA (CR). Its GMP standing is certified by EMA, MFDS (Korea) and US FDA. Its most recent recorded inspection, by US FDA, closed on 12 May 2023 as VAI.
2
registered plants
1 with an FDA FEI number
5
filings
across 3 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
- 12 May 2023 VAI US FDA
- 31 March 2023 NAI US FDA
- 23 November 2017 VAI US FDA
- 1 June 2016 NAI US FDA
- 27 March 2014 VAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| Sweden, Sweden | 3004620701 |
| Malmo, Sweden | Not on file |
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| ARCSA (EC) | 2 | None |
| NPRA (MY) | 2 | None |
| MINSA (CR) | 1 | None |
| EMA | None | 4 |
| MFDS (Korea) | None | 2 |
| US FDA | None | 1 |
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Open risk flags
- The most recent inspection outcome was VAI, on 12 May 2023.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates