Suppliers / Bayer, Oy

Bayer, Oy

Finland Updated 9 July 2026

Bayer, Oy is a finished-dose manufacturer based in Finland. It appears in 51 regulatory filings across 7 regulators, without an active US DMF or CEP on file. Its filings concentrate with EMA, INVIMA (CO) and DPM (TN). Its GMP standing is certified by ANVISA (Brazil), NAFDAC (NG) and US FDA, among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 15 September 2023 as VAI.

0
active US DMFs
0
valid CEPs
4
registered plants 1 with an FDA FEI number
51
filings across 7 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 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

  • 15 September 2023 VAI US FDA
  • 1 June 2018 VAI US FDA
  • 15 April 2016 VAI US FDA
  • 15 December 2011 NAI US FDA
  • 24 September 2010 NAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Turku, United Arab Emirates Not on file
TURKU, Finland Not on file
Finland, Finland 1000350927
Turku Finland, Nigeria Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA 34 1
INVIMA (CO) 4 None
DPM (TN) 4 None
ARCSA (EC) 3 None
MINSA (CR) 3 None
ANPP (DZ) 2 None
ANVISA (Brazil) None 2
NAFDAC (NG) None 1
US FDA None 1

Questions about Bayer, Oy

Does Bayer, Oy hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Bayer, Oy. It does have 51 filings with 7 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Bayer, Oy FDA-registered?
One site operated by Bayer, 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 Bayer, Oy's last inspection go?
The most recent inspection on record closed on 15 September 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Bayer, Oy manufacture?
4 registered sites are on record, in United Arab Emirates, Finland and Nigeria (Turku, Turku and Finland among others). Every site is listed on this page with the register it came from.
Which regulators recognise Bayer, Oy's GMP?
Current GMP certificates are on record from ANVISA (Brazil), NAFDAC (NG), 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 15 September 2023.

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Sources on this page

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