Suppliers / Bachem Americas

Bachem Americas

United States Updated 9 July 2026

The public registers hold a second record for Bachem Americas. The fuller profile, with 32 active US DMFs and 8 valid CEPs, is at Bachem. Figures on this page cover only this record.

Bachem Americas is an API manufacturer based in United States. It holds 7 active US drug master files and 4 valid CEPs across a filed portfolio of 8 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 28 June 2024 as VAI.

7
active US DMFs
4
valid CEPs
2
registered plants 2 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 28 June 2024 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
  • 18 May 2018 VAI US FDA
  • 25 February 2016 VAI US FDA
  • 7 November 2014 VAI US FDA

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

Registered plants

Site FDA FEI
Torrance, United States 2024023
Vista, United States 3000718309

What they file, and where

Molecule Regulators Docs
Desmopressin EDQM, US FDA 3
Calcitonin (Salmon) EDQM 2
Exenatide US FDA 1
Lanreotide US FDA 1
Liraglutide US FDA 1
Parathyroid Hormone US FDA 1
Salmon Calcitonin US FDA 1
Vasopressin US FDA 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Bachem Americas

Does Bachem Americas hold a US DMF or a CEP?
Bachem Americas holds 7 active US drug master files and 4 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 Americas FDA-registered?
2 sites operated by Bachem Americas 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 Americas's last inspection go?
The most recent inspection on record closed on 28 June 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Bachem Americas manufacture?
2 registered sites are on record, in United States (Torrance and Vista). Every site is listed on this page with the register it came from.
What does Bachem Americas make?
8 molecules are on record against Bachem Americas, including Desmopressin, Calcitonin (Salmon), Exenatide and Lanreotide. Each links through to that molecule's full manufacturer list.
Which regulators recognise Bachem Americas's GMP?
Current GMP certificates are on record from US FDA. 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 28 June 2024.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates