Suppliers / Bausch Health Companies

Bausch Health Companies

Canada BHC 387 employees Updated 9 July 2026

Bausch Health Companies is an API and finished-dose manufacturer based in Canada. It holds 3 active US drug master files across a filed portfolio of 3 molecules. Its filings concentrate with US FDA, HSA (SG) and ARCSA (EC). Its GMP standing is certified by ZLG (DE), EMA and US FDA, among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 19 January 2024 as NAI.

3
active US DMFs
0
valid CEPs
6
registered plants 3 with an FDA FEI number
359
filings across 6 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
0 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

  • 19 January 2024 NAI US FDA
  • 19 May 2023 NAI US FDA
  • 29 September 2022 NAI US FDA
  • 19 September 2019 NAI US FDA
  • 18 May 2018 NAI US FDA
  • 17 February 2017 NAI US FDA
  • 9 September 2016 NAI US FDA
  • 20 February 2015 VAI US FDA

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

Registered plants

Site FDA FEI
STEINBACH, Canada Not on file
Canada, Canada 3002806613
Canada, Canada 3002807186
Werne, Germany Not on file
Terrugem, Portugal Not on file
Conshohocken, United States 3004459493

What they file, and where

Molecule Regulators Docs
Metformin US FDA 1
Pirbuterol US FDA 1
Pyridostigmine US FDA 1

Also appears on these molecule pages

Acetylsalicylic Acid finished dose Albuterol finished dose Benzoyl Peroxide finished dose Bupropion finished dose Caffeine finished dose Chlordiazepoxide finished dose Chlorhexidine finished dose Ciclopirox finished dose Clindamycin finished dose Cromoglicic Acid finished dose Diltiazem finished dose Efinaconazole finished dose
Show 30 more molecule pages
Enalapril finished dose Erythromycin finished dose Famotidine finished dose Fenofibrate finished dose Fexofenadine finished dose Flucytosine finished dose Fluocinolone Acetonide finished dose Ganciclovir finished dose Hydrocortisone finished dose Imiquimod finished dose Ipratropium finished dose Isoprenaline finished dose Ketotifen finished dose Lansoprazole finished dose Lorazepam finished dose Megestrol finished dose Metformin API Minocycline finished dose Minoxidil finished dose Naphazoline finished dose Neomycin finished dose Nitroglycerin finished dose Omeprazole finished dose Phylloquinone finished dose Prednisolone finished dose Pyridostigmine API Salbutamol finished dose Timolol finished dose Tretinoin finished dose Triethylenetetramine finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 208 2
HSA (SG) 143 2
ARCSA (EC) 4 None
MINSA (CR) 2 None
DMP (NO) 1 None
INVIMA (CO) 1 None
ZLG (DE) None 8
EMA None 2
ANVISA (Brazil) None 1

Scale

Year Revenue Exports Destinations
2017 $2.2B Not reported Not reported
2016 $2.4B Not reported Not reported
2015 $2.8B Not reported Not reported

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

Questions about Bausch Health Companies

Does Bausch Health Companies hold a US DMF or a CEP?
Bausch Health Companies holds 3 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.
Is Bausch Health Companies FDA-registered?
3 sites operated by Bausch Health Companies 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 Bausch Health Companies's last inspection go?
The most recent inspection on record closed on 19 January 2024 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file.
Where does Bausch Health Companies manufacture?
6 registered sites are on record, in Canada, Germany, Portugal and United States (Steinbach, Canada and Werne among others). Every site is listed on this page with the register it came from.
What does Bausch Health Companies make?
3 molecules are on record against Bausch Health Companies, including Metformin, Pirbuterol and Pyridostigmine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Bausch Health Companies's GMP?
Current GMP certificates are on record from ZLG (DE), EMA, US FDA, HSA (SG) and ANVISA (Brazil). 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

  • 15 active litigation matters are on record.
  • The most recent inspection outcome was NAI, on 19 January 2024.

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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
Company filings
Revenue as reported