Suppliers / Bayer HealthCare

Bayer HealthCare

United States 5 duplicate records merged Updated 9 July 2026

Bayer HealthCare is a finished-dose manufacturer based in United States. It appears in 540 regulatory filings across 21 regulators, without an active US DMF or CEP on file. Its filings concentrate with DIGEMAPS (DO), DH (HK) and ANSM (FR). Its GMP standing is certified by ANSM (FR), US FDA and ANVISA (Brazil), among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 20 October 2025 as NAI.

0
active US DMFs
0
valid CEPs
6
registered plants 3 with an FDA FEI number
540
filings across 21 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

  • 20 October 2025 NAI US FDA
  • 15 August 2025 NAI US FDA
  • 17 December 2024 NAI US FDA
  • 30 October 2024 NAI US FDA
  • 7 June 2023 NAI US FDA
  • 26 August 2022 VAI US FDA
  • 15 September 2021 NAI US FDA
  • 21 November 2019 VAI US FDA

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

Registered plants

Site FDA FEI
LONS, France Not on file
Gaillard, France Not on file
BERKELEY, United States Not on file
Myerstown, United States 2510692
Morristown, United States 2243252
Berkeley, United States 2910913

Filings and GMP by regulator

Regulator Filings GMP certificates
DIGEMAPS (DO) 122 None
DH (HK) 86 None
ANSM (FR) 83 11
EMA 60 1
EDA (EG) 47 None
Health Canada 35 None
US FDA None 3
ANVISA (Brazil) None 1
NAFDAC (NG) None 1

Questions about Bayer HealthCare

Does Bayer HealthCare hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Bayer HealthCare. It does have 540 filings with 21 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Bayer HealthCare FDA-registered?
3 sites operated by Bayer HealthCare 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 HealthCare's last inspection go?
The most recent inspection on record closed on 20 October 2025 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file.
Where does Bayer HealthCare manufacture?
6 registered sites are on record, in France and United States (Lons, Gaillard and Berkeley among others). Every site is listed on this page with the register it came from.
Which regulators recognise Bayer HealthCare's GMP?
Current GMP certificates are on record from ANSM (FR), US FDA, ANVISA (Brazil), NAFDAC (NG) 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 NAI, on 20 October 2025.

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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