Suppliers / Bachem

Bachem

Switzerland BANBZ.XC reconciled across 12 public records · 5 entities Updated 9 July 2026

Bachem is an API manufacturer based in Switzerland. It holds 32 active US drug master files and 8 valid CEPs. Its filings concentrate with MINSA (CR) and INVIMA (CO). Its GMP standing is certified by EDQM, US FDA and EMA, among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 16 August 2024 as VAI.

32
active US DMFs
8
valid CEPs
7
registered plants 4 with an FDA FEI number
3
filings across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 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

  • 16 August 2024 VAI US FDA
  • 28 June 2024 VAI US FDA
  • 31 August 2023 VAI US FDA
  • 27 March 2023 VAI US FDA
  • 13 December 2019 VAI US FDA
  • 12 June 2019 VAI US FDA
  • 5 February 2019 NAI US FDA
  • 21 September 2018 VAI US FDA
  • 18 May 2018 VAI US FDA
  • 17 November 2017 NAI US FDA
  • 1 July 2016 VAI US FDA
  • 25 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
Bubendorf, Switzerland Not on file
Switzerland, Switzerland 1000153019
Vionnaz, Switzerland Not on file
Switzerland, Switzerland 3002808225
Heidelberg, Germany Not on file
Vista, United States 3000718309

1 further sites are on record.

What they file, and where

Molecule Regulators Docs
Goserelin EDQM, SFDA (Saudi Arabia), US FDA 4
Octreotide EDQM, SFDA (Saudi Arabia), US FDA 4
Propofol SFDA (Saudi Arabia), US FDA 4
Leuprolide EDQM, SFDA (Saudi Arabia), US FDA 3
Atosiban SFDA (Saudi Arabia) 2
Bivalirudin SFDA (Saudi Arabia), US FDA 2
Calcitonin (Salmon) EDQM 2
Desmopressin EDQM, US FDA 2
Glucagon US FDA 2
Gonadorelin EDQM, US FDA 2
Show all 30 molecules on file
Icatibant SFDA (Saudi Arabia), US FDA 2
Liraglutide US FDA 2
Triptorelin SFDA (Saudi Arabia), US FDA 2
Aminolevulinic Acid US FDA 1
Antazoline SFDA (Saudi Arabia) 1
Carbidopa US FDA 1
Eteplirsen SFDA (Saudi Arabia) 1
Etomidate US FDA 1
Exenatide US FDA 1
Glucagon Synthetic SFDA (Saudi Arabia) 1
Histrelin US FDA 1
Lanreotide US FDA 1
Parathyroid Hormone US FDA 1
Pegcetacoplan SFDA (Saudi Arabia) 1
Salmon Calcitonin US FDA 1
Semaglutide US FDA 1
Sincalide US FDA 1
Somatostatin EDQM 1
Tetracosactide US FDA 1
Vasopressin US FDA 1

Also appears on these molecule pages

Bivalirudin contract manufacturing Carbidopa contract manufacturing Desmopressin contract manufacturing Etomidate contract manufacturing Exenatide contract manufacturing Icatibant contract manufacturing Lanreotide contract manufacturing Leuprolide contract manufacturing Liraglutide API Octreotide contract manufacturing Propofol contract manufacturing Semaglutide API
Show 3 more molecule pages
Somatostatin contract manufacturing Triptorelin contract manufacturing Vasopressin contract manufacturing

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 2 None
INVIMA (CO) 1 None
EDQM None 7
US FDA None 3
EMA None 3
ZLG (DE) None 2

Questions about Bachem

Does Bachem hold a US DMF or a CEP?
Bachem holds 32 active US drug master files and 8 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 Bachem FDA-registered?
4 sites operated by Bachem 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 Bachem's last inspection go?
The most recent inspection on record closed on 16 August 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 23 inspections are on file.
Where does Bachem manufacture?
7 registered sites are on record, in Switzerland, Germany and United States (Bubendorf, Switzerland and Vionnaz among others). Every site is listed on this page with the register it came from.
What does Bachem make?
30 molecules are on record against Bachem, including Goserelin, Octreotide, Propofol and Leuprolide. Each links through to that molecule's full manufacturer list.
Which regulators recognise Bachem's GMP?
Current GMP certificates are on record from EDQM, US FDA, EMA and ZLG (DE). 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 16 August 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