Suppliers / Solventum US

Solventum US

United States Updated 9 July 2026

Solventum US is a finished-dose manufacturer based in United States. It holds one valid CEP. Its filings concentrate with Health Canada, US FDA and EMA. Its GMP standing is certified by ZLG (DE), US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 6 September 2024 as VAI.

0
active US DMFs
1
valid CEPs
4
registered plants 2 with an FDA FEI number
16
filings across 3 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
2 of 2 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

  • 6 September 2024 VAI US FDA
  • 4 February 2016 VAI US FDA

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

Registered plants

Site FDA FEI
Kamen, Germany Not on file
Seefeld, Germany Not on file
Eagan, United States 3042272797
Columbia, United States 3003399824

What they file, and where

Molecule Regulators Docs
Collagen EDQM 1

Also appears on these molecule pages

Chlorhexidine finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
Health Canada 9 None
US FDA 5 1
EMA 2 1
ZLG (DE) None 4

Questions about Solventum US

Does Solventum US hold a US DMF or a CEP?
Solventum US holds 1 valid CEP. 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 Solventum US FDA-registered?
2 sites operated by Solventum US 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 Solventum US's last inspection go?
The most recent inspection on record closed on 6 September 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 2 inspections are on file.
Where does Solventum US manufacture?
4 registered sites are on record, in Germany and United States (Kamen, Seefeld and Eagan among others). Every site is listed on this page with the register it came from.
What does Solventum US make?
1 molecule is on record against Solventum US, including Collagen. Each links through to that molecule's full manufacturer list.
Which regulators recognise Solventum US's GMP?
Current GMP certificates are on record from ZLG (DE), US FDA 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 VAI, on 6 September 2024.

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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