Suppliers / Bayer

Bayer

Finland 59 employees 14 duplicate records merged Updated 9 July 2026

Bayer is an API and finished-dose manufacturer based in Finland. It holds 29 valid CEPs across a filed portfolio of 26 molecules. Its filings concentrate with Health Canada, FAMHP (BE) and MHRA (UK). Its GMP standing is certified by ZLG (DE), EMA and ANVISA (Brazil), among 7 authorities. Its most recent recorded inspection, by US FDA, closed on 14 November 2024 as VAI. Customs aggregates show $37.4M of exports covering 309 molecules to 11 destinations in 2025.

0
active US DMFs
29
valid CEPs
12
registered plants 3 with an FDA FEI number
2,010
filings across 22 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
3 of 3 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

  • 14 November 2024 VAI US FDA
  • 14 November 2024 VAI US FDA
  • 19 June 2024 VAI US FDA
  • 6 June 2024 VAI US FDA
  • 6 June 2024 VAI US FDA
  • 15 September 2023 VAI US FDA
  • 7 September 2023 VAI US FDA
  • 7 September 2023 VAI US FDA

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

Registered plants

Site FDA FEI
Leverkusen, United Arab Emirates Not on file
Berlin, United Arab Emirates Not on file
Bitterfeld-Wolfen, United Arab Emirates Not on file
06803Bitterfeld-Wolfen, United Arab Emirates Not on file
LEVERKUSEN, Germany Not on file
BITTERFELD-WOLFEN, Germany Not on file

6 further sites are on record.

What they file, and where

Molecule Regulators Docs
Norethisterone EDQM 4
Testosterone EDQM, SFDA (Saudi Arabia) 3
Ciprofloxacin EDQM 2
Estradiol EDQM, SFDA (Saudi Arabia) 2
Gadobutrol EDQM, SFDA (Saudi Arabia) 2
Iopromide EDQM 2
Moxifloxacin EDQM, SFDA (Saudi Arabia) 2
Acarbose EDQM 1
Cyproterone EDQM 1
Cyproterone Acetate EDQM 1
Show all 26 molecules on file
Drospirenone EDQM 1
Estradiol Valerate EDQM 1
Estriol EDQM 1
Ethinylestradiol EDQM 1
Etofenamate EDQM 1
Gestodene EDQM 1
Hydrocortisone EDQM 1
Iloprost SFDA (Saudi Arabia) 1
Levonorgestrel EDQM 1
Medroxyprogesterone Acetate EDQM 1
Moxifloxacin Hydrochloride EDQM 1
Nifedipine EDQM 1
Regorafenib SFDA (Saudi Arabia) 1
Riociguat SFDA (Saudi Arabia) 1
Rivaroxaban EDQM 1
Testosterone Enantate EDQM 1

Also appears on these molecule pages

Acarbose contract manufacturing Acetylsalicylic Acid finished dose Caffeine finished dose Calcium Carbonate finished dose Captopril finished dose Cilostazol finished dose Ciprofloxacin contract manufacturing Clotrimazole finished dose Cyproterone API Darolutamide finished dose Desloratadine finished dose Dextromethorphan finished dose
Show 41 more molecule pages
Dienogest finished dose Diphenhydramine finished dose Drospirenone contract manufacturing Estradiol contract manufacturing Ethinylestradiol API Famotidine finished dose Finerenone finished dose Fluconazole finished dose Gadobutrol API Gadoteric Acid finished dose Guaifenesin finished dose Hydrocortisone API Ibuprofen finished dose Iloprost API Iopromide API Levetiracetam finished dose Levonorgestrel contract manufacturing Loratadine finished dose Medroxyprogesterone API Mometasone finished dose Moxifloxacin API Naproxen finished dose Nifedipine API Nimodipine finished dose Norethisterone contract manufacturing Norgestrel contract manufacturing Ofloxacin contract manufacturing Oxymetazoline finished dose Praziquantel finished dose Pseudoephedrine finished dose Regorafenib API Riociguat API Simethicone finished dose Sorafenib finished dose Sucralfate finished dose Telmisartan finished dose Testosterone contract manufacturing Testosterone Undecanoate finished dose Vardenafil finished dose Vericiguat finished dose Rivaroxaban API

Filings and GMP by regulator

Regulator Filings GMP certificates
Health Canada 374 None
FAMHP (BE) 314 None
MHRA (UK) 291 None
AIFA (IT) 270 None
EMA 184 19
INHRR (VE) 115 None
ZLG (DE) None 122
ANVISA (Brazil) None 9
US FDA None 8
NAFDAC (NG) None 6
MINPROMTORG (RU) None 6
MFDS (Korea) None 4

Scale

Year Revenue Exports Destinations
2025 Not reported $37.4M 11
2024 Not reported $64.2M 10
2023 Not reported $231K 1

Export figures are customs aggregates. We do not publish the identity of any buyer.

Questions about Bayer

Does Bayer hold a US DMF or a CEP?
Bayer holds 29 valid CEPs. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Bayer FDA-registered?
3 sites operated by Bayer carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Bayer's last inspection go?
The most recent inspection on record closed on 14 November 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Bayer manufacture?
12 registered sites are on record, in United Arab Emirates and Germany (Leverkusen, Berlin and Bitterfeld-wolfen among others). Every site is listed on this page with the register it came from.
What does Bayer make?
26 molecules are on record against Bayer, including Norethisterone, Testosterone, Ciprofloxacin and Estradiol. Each links through to that molecule's full manufacturer list.
Which regulators recognise Bayer's GMP?
Current GMP certificates are on record from ZLG (DE), EMA, ANVISA (Brazil), US FDA, NAFDAC (NG) and 2 more. 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 14 November 2024.

Comparable suppliers

Bayer S/A shares 12 molecules Lupin shares 7 molecules Symbiotec Pharmalab shares 6 molecules zhejiang xianju pharmaceutical shares 6 molecules “Gedeon Richter” shares 5 molecules

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
Customs aggregates
Export values, molecule and destination counts