Suppliers / Amino Chemicals

Amino Chemicals

Germany 42 employees reconciled across 8 public records · 3 entities Updated 9 July 2026

Amino Chemicals is an API and finished-dose manufacturer based in Germany. It holds 25 active US drug master files and 22 valid CEPs. Its filings concentrate with SWISSMEDIC (CH), MINSA (CR) and EDE (AE). Its GMP standing is certified by EDQM, ZLG (DE) and EMA, among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 7 November 2024 as VAI.

25
active US DMFs
22
valid CEPs
8
registered plants 2 with an FDA FEI number
147
filings across 3 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
3 of 3 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

  • 7 November 2024 VAI US FDA
  • 12 May 2022 VAI US FDA
  • 21 September 2018 VAI US FDA
  • 5 August 2016 VAI US FDA
  • 13 November 2015 VAI US FDA
  • 18 April 2014 VAI US FDA
  • 7 December 2011 VAI US FDA
  • 30 September 2011 VAI US FDA

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

Registered plants

Site FDA FEI
Belp, United Arab Emirates Not on file
Gebenstorf, Switzerland Not on file
Belp, Switzerland Not on file
Gebenstorf, Switzerland Not on file
Germany, Germany 3002806319
Lower Saxony, Germany Not on file

2 further sites are on record.

What they file, and where

Molecule Regulators Docs
Leucine EDQM, SFDA (Saudi Arabia), US FDA 6
Threonine EDQM, SFDA (Saudi Arabia), US FDA 4
Tyrosine EDQM, SFDA (Saudi Arabia), US FDA 4
Alanine EDQM, SFDA (Saudi Arabia), US FDA 3
Betaine SFDA (Saudi Arabia), US FDA 3
Histidine EDQM, SFDA (Saudi Arabia), US FDA 3
Isoleucine EDQM, SFDA (Saudi Arabia), US FDA 3
Phenylalanine EDQM, SFDA (Saudi Arabia), US FDA 3
Serine EDQM, SFDA (Saudi Arabia) 3
Tryptophan EDQM, SFDA (Saudi Arabia), US FDA 3
Show all 34 molecules on file
Valine EDQM, SFDA (Saudi Arabia), US FDA 3
Arginine EDQM, SFDA (Saudi Arabia) 2
Aspartic Acid EDQM, US FDA 2
Methionine EDQM, US FDA 2
N-Acetyltyrosine EDQM, US FDA 2
Pramipexole US FDA 2
Amphotericin B SFDA (Saudi Arabia) 1
Asparagine EDQM 1
Benazepril US FDA 1
Bosentan US FDA 1
Glutamic Acid EDQM 1
Glycine EDQM 1
Lysine EDQM 1
Miglustat SFDA (Saudi Arabia) 1
N-Acetyltryptophan EDQM 1
Paliperidone US FDA 1
Pantoprazole SFDA (Saudi Arabia) 1
Pramipexole Base SFDA (Saudi Arabia) 1
Proline SFDA (Saudi Arabia) 1
Rasagiline US FDA 1
Telmisartan US FDA 1
Terbinafine US FDA 1
Tolterodine US FDA 1
Ziprasidone US FDA 1

Also appears on these molecule pages

Alanine API Arginine API Aspartic Acid API Ephedrine finished dose Glutamic Acid API Histidine API Isoleucine API Leucine API Lysine API Methadone finished dose Methionine API Phenylalanine API
Show 5 more molecule pages
Proline API Serine API Succinylcholine finished dose Threonine API Valine API

Filings and GMP by regulator

Regulator Filings GMP certificates
SWISSMEDIC (CH) 138 None
MINSA (CR) 5 None
EDE (AE) 4 None
EDQM None 22
ZLG (DE) None 6
EMA None 4
US FDA None 1

Questions about Amino Chemicals

Does Amino Chemicals hold a US DMF or a CEP?
Amino Chemicals holds 25 active US drug master files and 22 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 Amino Chemicals FDA-registered?
2 sites operated by Amino Chemicals 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 Amino Chemicals's last inspection go?
The most recent inspection on record closed on 7 November 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Amino Chemicals manufacture?
8 registered sites are on record, in United Arab Emirates, Switzerland, Germany and Malta (Belp, Gebenstorf and Germany among others). Every site is listed on this page with the register it came from.
What does Amino Chemicals make?
34 molecules are on record against Amino Chemicals, including Leucine, Threonine, Tyrosine and Alanine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Amino Chemicals's GMP?
Current GMP certificates are on record from EDQM, ZLG (DE), EMA and 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 7 November 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