Suppliers / Bayer

Bayer

Germany 59 employees 14 duplicate records merged Updated 9 July 2026

Bayer is an API and finished-dose manufacturer based in Germany. 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.

0
active US DMFs
29
valid CEPs
12
registered plants 2 with an FDA FEI number
53
filings across 8 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
3 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
06803Bitterfeld-Wolfen, United Arab Emirates Not on file
Bitterfeld-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

Acetylsalicylic Acid finished dose Caffeine finished dose Cilostazol finished dose Ciprofloxacin contract manufacturing Clotrimazole finished dose Desloratadine finished dose Dextromethorphan finished dose Diphenhydramine finished dose Drospirenone contract manufacturing Estradiol contract manufacturing Ethinylestradiol API Famotidine finished dose
Show 21 more molecule pages
Fluconazole finished dose Guaifenesin finished dose Hydrocortisone API Ibuprofen finished dose Levetiracetam finished dose Levonorgestrel contract manufacturing Loratadine finished dose Mometasone finished dose Moxifloxacin API Naproxen finished dose Nifedipine API Nimodipine finished dose Norethisterone contract manufacturing Ofloxacin contract manufacturing Praziquantel finished dose Pseudoephedrine finished dose Sucralfate finished dose Telmisartan finished dose Testosterone contract manufacturing Testosterone Undecanoate 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
MINPROMTORG (RU) None 6
NAFDAC (NG) None 6
MFDS (Korea) None 4

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Open risk flags

  • The most recent inspection outcome was VAI, on 14 November 2024.

Sources on this page

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