Suppliers / Amino Chemicals

Amino Chemicals

Malta 78 employees Updated 9 July 2026

The public registers hold a second record for Amino Chemicals. The fuller profile, with 25 active US DMFs and 22 valid CEPs, is at Amino Chemicals. Figures on this page cover only this record.

Amino Chemicals is an API manufacturer based in Malta. It holds 10 active US drug master files across a filed portfolio of 12 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 7 November 2024 as VAI.

10
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
5
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 7 November 2024 VAI US FDA
  • 21 September 2018 VAI US FDA
  • 5 August 2016 VAI US FDA
  • 18 April 2014 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
Malta, Malta 3003118161

What they file, and where

Molecule Regulators Docs
Pramipexole US FDA 2
Benazepril US FDA 1
Bosentan US FDA 1
Miglustat SFDA (Saudi Arabia) 1
Paliperidone US FDA 1
Pantoprazole SFDA (Saudi Arabia) 1
Pramipexole Base SFDA (Saudi Arabia) 1
Rasagiline US FDA 1
Telmisartan US FDA 1
Terbinafine US FDA 1
Show all 12 molecules on file
Tolterodine US FDA 1
Ziprasidone US FDA 1

Also appears on these molecule pages

Benazepril API Bosentan API Miglustat API Paliperidone API Pramipexole API Rasagiline API Terbinafine API Tolterodine API Ziprasidone API Pantoprazole API Telmisartan API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 5 None
US FDA None 1

Questions about Amino Chemicals

Does Amino Chemicals hold a US DMF or a CEP?
Amino Chemicals holds 10 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 Amino Chemicals FDA-registered?
One site operated by Amino Chemicals carries an FDA establishment identifier (FEI), which means it is 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). 5 inspections are on file.
Where does Amino Chemicals manufacture?
1 registered site is on record, in Malta (Malta). Every site is listed on this page with the register it came from.
What does Amino Chemicals make?
12 molecules are on record against Amino Chemicals, including Pramipexole, Benazepril, Bosentan and Miglustat. Each links through to that molecule's full manufacturer list.
Which regulators recognise Amino Chemicals'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

  • 7 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 7 November 2024.

Comparable suppliers

Apitoria Pharma shares 7 molecules Dr Reddy's Laboratories shares 5 molecules Macleods Pharmaceuticals shares 5 molecules MSN Laboratories shares 4 molecules Cipla shares 4 molecules

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