Suppliers / Basf

Basf

Germany 8 duplicate records merged Updated 9 July 2026

The public registers hold a second record for Basf. The fuller profile, with 17 active US DMFs and 14 valid CEPs, is at BASF. Figures on this page cover only this record.

Basf is an API and finished-dose manufacturer based in Germany. It holds 9 active US drug master files across a filed portfolio of 6 molecules. Its filings concentrate with EEC_EAEU, URPL (PL) and MINSA (CR). Its GMP standing is certified by ANSM (FR), US FDA and MFDS (Korea), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 29 May 2025 as VAI.

9
active US DMFs
0
valid CEPs
5
registered plants 3 with an FDA FEI number
57
filings across 10 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
3 of 3 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 29 May 2025 VAI US FDA
  • 11 September 2024 NAI US FDA
  • 22 July 2024 VAI US FDA
  • 9 October 2018 NAI US FDA
  • 17 November 2017 VAI US FDA
  • 23 October 2015 VAI US FDA
  • 20 February 2014 NAI US FDA
  • 25 October 2013 VAI US FDA

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

Registered plants

Site FDA FEI
SAINT VULBAS, France Not on file
Prior Velho, Portugal Not on file
Geismar, United States 2316568
East Setauket, United States 1000521506
Bishop, United States 3001451837

What they file, and where

Molecule Regulators Docs
Ibuprofen SFDA (Saudi Arabia), US FDA 4
Omega-3 Fatty Acids US FDA 2
Icosapent Ethyl US FDA 1
Omega-3-Acid Ethyl Esters US FDA 1
Poloxalene US FDA 1
Polyethylene Glycol US FDA 1

Also appears on these molecule pages

Dexpanthenol finished dose Ibuprofen API Icosapent Ethyl API Omega-3-Acid Ethyl Esters API Omega-3 Fatty Acids API

Filings and GMP by regulator

Regulator Filings GMP certificates
EEC_EAEU 26 None
URPL (PL) 9 None
MINSA (CR) 6 None
US FDA 6 3
EMA 4 None
INFARMED (PT) 2 2
ANSM (FR) None 8
MFDS (Korea) None 2

Questions about Basf

Does Basf hold a US DMF or a CEP?
Basf holds 9 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 Basf FDA-registered?
3 sites operated by Basf 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 Basf's last inspection go?
The most recent inspection on record closed on 29 May 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Basf manufacture?
5 registered sites are on record, in France, Portugal and United States (Saint Vulbas, Prior Velho and Geismar among others). Every site is listed on this page with the register it came from.
What does Basf make?
6 molecules are on record against Basf, including Ibuprofen, Omega-3 Fatty Acids, Icosapent Ethyl and Omega-3-Acid Ethyl Esters. Each links through to that molecule's full manufacturer list.
Which regulators recognise Basf's GMP?
Current GMP certificates are on record from ANSM (FR), US FDA, MFDS (Korea) and INFARMED (PT). 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 29 May 2025.

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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