Mcneil Ab
Sweden Updated 9 July 2026
Mcneil Ab is a finished-dose manufacturer based in Sweden. It appears in 13 regulatory filings across 2 regulators, without an active US DMF or CEP on file. Its filings concentrate with US FDA and EDA (EG). Its GMP standing is certified by EMA and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 15 June 2022 as VAI.
2
registered plants
1 with an FDA FEI number
13
filings
across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
4 of 4 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
- 15 June 2022 VAI US FDA
- 27 November 2019 VAI US FDA
- 25 May 2018 VAI US FDA
- 13 December 2013 NAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| HELSINGBORG, Sweden | Not on file |
| Sweden, Sweden | 1000409186 |
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| US FDA | 7 | None |
| EDA (EG) | 6 | None |
| EMA | None | 3 |
| ANVISA (Brazil) | None | 1 |
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Open risk flags
- The most recent inspection outcome was VAI, on 15 June 2022.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates