Suppliers / Bayer S/A

Bayer S/A

Brazil 3 duplicate records merged Updated 9 July 2026

Bayer S/A is an API and finished-dose manufacturer based in Brazil. It holds 26 active US drug master files across a filed portfolio of 20 molecules. Its filings concentrate with ANVISA (Brazil), Health Canada and EMA. Its GMP standing is certified by BPOM (ID), ZLG (DE) and COFEPRIS (MX), among 11 authorities. Its most recent recorded inspection, by US FDA, closed on 20 July 2023 as VAI.

26
active US DMFs
0
valid CEPs
12
registered plants
4,668
filings across 46 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
0 of 8 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 20 July 2023 VAI US FDA
  • 17 June 2022 VAI US FDA
  • 9 July 2019 VAI US FDA
  • 19 April 2019 VAI US FDA
  • 17 June 2016 NAI US FDA
  • 16 October 2015 NAI US FDA
  • 20 June 2014 VAI US FDA
  • 15 March 2013 NAI 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
Garbagnate Milanese, United Arab Emirates Not on file
Turku, United Arab Emirates Not on file
Casablanca, United Arab Emirates Not on file
BUENOS AIRES, Argentina Not on file

6 further sites are on record.

What they file, and where

Molecule Regulators Docs
Ciprofloxacin US FDA 3
Azelaic Acid US FDA 2
Norethisterone US FDA 2
Rivaroxaban US FDA 2
Testosterone US FDA 2
Acarbose US FDA 1
Dienogest US FDA 1
Drospirenone US FDA 1
Estradiol US FDA 1
Estradiol Valerate US FDA 1
Show all 20 molecules on file
Ethinylestradiol US FDA 1
Gadobutrol US FDA 1
Iloprost US FDA 1
Iopromide US FDA 1
Levonorgestrel US FDA 1
Medroxyprogesterone Acetate US FDA 1
Molidustat US FDA 1
Norgestrel US FDA 1
Testosterone Enanthate US FDA 1
Testosterone Undecanoate US FDA 1

Also appears on these molecule pages

Acarbose API Acetylsalicylic Acid finished dose Ambroxol finished dose Ampicillin finished dose Azelaic Acid API Azelastine finished dose Caffeine finished dose Calcium Carbonate finished dose Chlorphenamine finished dose Chlorpheniramine finished dose Ciprofloxacin API Clopidogrel finished dose
Show 46 more molecule pages
Clotrimazole finished dose Cobalamin finished dose Cyproterone finished dose Dacarbazine finished dose Darolutamide finished dose Desloratadine finished dose Dexpanthenol finished dose Dienogest API Diphenhydramine finished dose Dobutamine finished dose Drospirenone API Estradiol API Ethinylestradiol API Finerenone finished dose Gadobutrol API Iloprost API Iopromide API Ketoprofen finished dose Levonorgestrel API Lithium Carbonate finished dose Loratadine finished dose Medroxyprogesterone API Methylprednisolone finished dose Miconazole finished dose Mometasone finished dose Moxifloxacin finished dose Naproxen finished dose Neomycin finished dose Nifedipine finished dose Nimodipine finished dose Norethisterone API Norgestrel API Oxymetazoline finished dose Phenobarbital finished dose Praziquantel finished dose Prednisone finished dose Pseudoephedrine finished dose Regorafenib finished dose Riociguat finished dose Sorafenib finished dose Tedizolid finished dose Testosterone API Testosterone Undecanoate API Vardenafil finished dose Vericiguat finished dose Rivaroxaban API

Filings and GMP by regulator

Regulator Filings GMP certificates
ANVISA (Brazil) 424 5
Health Canada 419 None
EMA 364 7
INHRR (VE) 341 None
MHRA (UK) 291 2
AIFA (IT) 269 None
BPOM (ID) None 12
ZLG (DE) None 10
COFEPRIS (MX) None 8
HSA (SG) None 4
TMDA (TZ) None 4
MFDS (Korea) None 4
NAFDAC (NG) None 2
US FDA None 1

Questions about Bayer S/A

Does Bayer S/A hold a US DMF or a CEP?
Bayer S/A holds 26 active US drug master files. 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.
How did Bayer S/A's last inspection go?
The most recent inspection on record closed on 20 July 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Bayer S/A manufacture?
12 registered sites are on record, in United Arab Emirates, Argentina, Brazil and Switzerland (Leverkusen, Berlin and Garbagnate Milanese among others). Every site is listed on this page with the register it came from.
What does Bayer S/A make?
20 molecules are on record against Bayer S/A, including Ciprofloxacin, Azelaic Acid, Norethisterone and Rivaroxaban. Each links through to that molecule's full manufacturer list.
Which regulators recognise Bayer S/A's GMP?
Current GMP certificates are on record from BPOM (ID), ZLG (DE), COFEPRIS (MX), EMA, ANVISA (Brazil) and 6 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

  • 14 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 20 July 2023.

Comparable suppliers

Bayer shares 12 molecules Lupin shares 7 molecules “Gedeon Richter” shares 7 molecules Symbiotec Pharmalab shares 6 molecules Aspen Oss 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