Pcas Finland Oy
Finland Updated 9 July 2026
Pcas Finland Oy is an API manufacturer based in Finland. It appears in 3 regulatory filings across 3 regulators, without an active US DMF or CEP on file. Its filings concentrate with INVIMA (CO), ARCSA (EC) and MINSA (CR). Its GMP standing is certified by US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 7 June 2024 as VAI.
1
registered plants
1 with an FDA FEI number
3
filings
across 3 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. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.
Inspection history
- 7 June 2024 VAI US FDA
- 10 January 2024 VAI US FDA
- 13 September 2019 VAI US FDA
- 15 September 2017 VAI US FDA
- 15 May 2015 NAI US FDA
- 8 February 2013 VAI US FDA
- 25 September 2010 VAI US FDA
- 28 November 2008 VAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| Finland, Finland | 3003469991 |
What they file, and where
| Molecule | Regulators | Docs |
| Baclofen | SFDA (Saudi Arabia) | 1 |
Also appears on these molecule pages
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| INVIMA (CO) | 1 | None |
| ARCSA (EC) | 1 | None |
| MINSA (CR) | 1 | None |
| US FDA | None | 1 |
| EMA | None | 1 |
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Open risk flags
- The most recent inspection outcome was VAI, on 7 June 2024.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates