Suppliers / Pcas Finland Oy

Pcas Finland Oy

Finland Updated 9 July 2026

The public registers hold a second record for Pcas Finland Oy. The fuller profile, with 31 active US DMFs and 0 valid CEPs, is at PCAS. Figures on this page cover only this record.

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 ARCSA (EC), INVIMA (CO) 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.

0
active US DMFs
0
valid CEPs
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
Plants
1 of 1 confirmed
Inspections
8 of 8 confirmed
EU GMP
1 of 1 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

Baclofen API

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 1 None
INVIMA (CO) 1 None
MINSA (CR) 1 None
US FDA None 1
EMA None 1

Questions about Pcas Finland Oy

Does Pcas Finland Oy hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Pcas Finland Oy. It does have 3 filings with 3 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Pcas Finland Oy FDA-registered?
One site operated by Pcas Finland Oy carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Pcas Finland Oy's last inspection go?
The most recent inspection on record closed on 7 June 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Pcas Finland Oy manufacture?
1 registered site is on record, in Finland (Finland). Every site is listed on this page with the register it came from.
What does Pcas Finland Oy make?
1 molecule is on record against Pcas Finland Oy, including Baclofen. Each links through to that molecule's full manufacturer list.
Which regulators recognise Pcas Finland Oy's GMP?
Current GMP certificates are on record from US FDA and EMA. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Open risk flags

  • The most recent inspection outcome was VAI, on 7 June 2024.

Comparable suppliers

Bayer, Oy also in Finland Orion also in Finland Bayer also in Finland Fermion also in Finland

Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates