Suppliers / BASF

BASF

Germany reconciled across 155 public records · 30 entities Updated 9 July 2026

BASF is an API manufacturer based in Germany. It holds 17 active US drug master files and 14 valid CEPs across a filed portfolio of 28 molecules. Its filings concentrate with EEC_EAEU, URPL (PL) and MINSA (CR). Its GMP standing is certified by ANSM (FR), ZLG (DE) and US FDA, among 7 authorities. Its most recent recorded inspection, by US FDA, closed on 29 May 2025 as VAI.

17
active US DMFs
14
valid CEPs
15
registered plants 6 with an FDA FEI number
83
filings across 11 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
6 of 6 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

  • 29 May 2025 VAI US FDA
  • 24 January 2025 VAI US FDA
  • 11 September 2024 NAI US FDA
  • 29 August 2024 VAI US FDA
  • 22 July 2024 VAI US FDA
  • 1 December 2022 VAI US FDA
  • 16 September 2020 VAI US FDA
  • 23 August 2019 VAI US FDA
  • 9 October 2018 NAI US FDA
  • 13 July 2018 VAI US FDA
  • 23 March 2018 VAI US FDA
  • 17 November 2017 VAI US FDA

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

Registered plants

Site FDA FEI
Limburgerhof, Germany Not on file
Grenzach-Wyhlen, Germany Not on file
Minden, Germany Not on file
Germany, Germany 3002903906
Rhineland-Palatinate, Germany Not on file
Ludwigshafen, Germany Not on file

9 further sites are on record.

What they file, and where

Molecule Regulators Docs
Ibuprofen EDQM, SFDA (Saudi Arabia), US FDA 10
Omega-3 Fatty Acids US FDA 4
Levomenthol EDQM, SFDA (Saudi Arabia), US FDA 3
Dexpanthenol EDQM, SFDA (Saudi Arabia) 2
Icosapent Ethyl US FDA 2
Isotretinoin SFDA (Saudi Arabia) 2
Omega-3-Acid Ethyl Esters US FDA 2
Paroxetine SFDA (Saudi Arabia) 2
Poloxalene US FDA 2
Polyethylene Glycol US FDA 2
Show all 28 molecules on file
Povidone EDQM 2
Povidone-Iodine EDQM, US FDA 2
Calcium Pantothenate EDQM 1
Copovidone EDQM 1
Crospovidone EDQM 1
Dl-Alpha Tocopheryl Acetate EDQM 1
Dl-Alpha-Tocopherol EDQM 1
Ephedrine SFDA (Saudi Arabia) 1
Phenoxyethanol EDQM 1
Riboflavin EDQM 1
Roflumilast SFDA (Saudi Arabia) 1
Triclosan US FDA 1
Vitamin A EDQM 1
マクソメガＥｐａ９７Ｅｅ PMDA (Japan) 1
リボフラビンＲｉｂｏｆｌａｖｉｎ PMDA (Japan) 1
酢酸トコフェロールＶｉｔａｍｉｎｅａｃｅｔａｔｅ PMDA (Japan) 1
Ｌ－メントールＬ－Ｍｅｎｔｈｏｌ PMDA (Japan) 1
Ｒｉｂｏｆｌａｖｉｎ PMDA (Japan) 1

Also appears on these molecule pages

Crospovidone API Dexpanthenol API Ibuprofen API Levomenthol API Povidone-Iodine API

Filings and GMP by regulator

Regulator Filings GMP certificates
EEC_EAEU 89 None
URPL (PL) 18 None
MINSA (CR) 10 None
US FDA 6 5
EMA 6 2
INFARMED (PT) 4 4
ANSM (FR) None 16
ZLG (DE) None 10
MFDS (Korea) None 4
HSA (SG) None 1

Questions about BASF

Does BASF hold a US DMF or a CEP?
BASF holds 17 active US drug master files and 14 valid CEPs. 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?
6 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). 24 inspections are on file.
Where does BASF manufacture?
15 registered sites are on record, in Germany, Denmark, France and United Kingdom (Limburgerhof, Grenzach-wyhlen and Minden among others). Every site is listed on this page with the register it came from.
What does BASF make?
28 molecules are on record against BASF, including Ibuprofen, Omega-3 Fatty Acids, Levomenthol and Dexpanthenol. 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), ZLG (DE), US FDA, MFDS (Korea), INFARMED (PT) and 2 more. 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

  • 19 active litigation matters are on record.
  • 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