Suppliers / Medichem Manufacturing (Malta)

Medichem Manufacturing (Malta)

Malta Updated 9 July 2026

Medichem Manufacturing (Malta) is an API manufacturer based in Malta. It holds 11 active US drug master files and 3 valid CEPs across a filed portfolio of 14 molecules. Its most recent recorded inspection, by US FDA, closed on 23 May 2018 as VAI.

11
active US DMFs
3
valid CEPs
2
registered plants 1 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
3 of 3 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 23 May 2018 VAI US FDA
  • 19 February 2015 NAI US FDA
  • 19 April 2012 NAI US FDA

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

Registered plants

Site FDA FEI
Hal Far, Malta Not on file
Malta, Malta 3005427637

What they file, and where

Molecule Regulators Docs
Apixaban SFDA (Saudi Arabia), US FDA 3
Micafungin SFDA (Saudi Arabia), US FDA 3
Rivaroxaban EDQM, SFDA (Saudi Arabia), US FDA 3
Voriconazole EDQM, SFDA (Saudi Arabia) 2
Ambrisentan US FDA 1
Cinacalcet US FDA 1
Edaravone US FDA 1
Lofexidine US FDA 1
Prucalopride US FDA 1
Revefenacin US FDA 1
Show all 14 molecules on file
Solifenacin Succinate EDQM 1
Sugammadex US FDA 1
Sunitinib US FDA 1
スガマデクスナトリウム PMDA (Japan) 1

Also appears on these molecule pages

Ambrisentan API Cinacalcet API Edaravone API Micafungin API Prucalopride API Revefenacin API Sunitinib API Voriconazole API Rivaroxaban API Solifenacin API Apixaban API Sugammadex API

Questions about Medichem Manufacturing (Malta)

Does Medichem Manufacturing (Malta) hold a US DMF or a CEP?
Medichem Manufacturing (Malta) holds 11 active US drug master files and 3 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 Medichem Manufacturing (Malta) FDA-registered?
One site operated by Medichem Manufacturing (Malta) 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 Medichem Manufacturing (Malta)'s last inspection go?
The most recent inspection on record closed on 23 May 2018 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does Medichem Manufacturing (Malta) manufacture?
2 registered sites are on record, in Malta (Hal Far and Malta). Every site is listed on this page with the register it came from.
What does Medichem Manufacturing (Malta) make?
14 molecules are on record against Medichem Manufacturing (Malta), including Apixaban, Micafungin, Rivaroxaban and Voriconazole. Each links through to that molecule's full manufacturer list.

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

  • 2 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 23 May 2018.

Comparable suppliers

MSN Laboratories shares 6 molecules Apitoria Pharma shares 4 molecules Hetero shares 4 molecules Cipla shares 4 molecules Dr Reddy's Laboratories shares 3 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