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 NAFDAC (NG), 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
Berkeley, United States 2910913
Morristown, United States 2243252

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
NAFDAC (NG) None 1
ANVISA (Brazil) None 1

Comparing suppliers?

Choose your molecules and target markets. Bayer HealthCare comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Open risk flags

  • The most recent inspection outcome was NAI, on 20 October 2025.

Sources on this page

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