Suppliers / Sterling Chemical Malta

Sterling Chemical Malta

Malta 64 employees Updated 9 July 2026

Sterling Chemical Malta is an API manufacturer based in Malta. It holds 5 active US drug master files and 4 valid CEPs across a filed portfolio of 8 molecules. Its most recent recorded inspection, by US FDA, closed on 1 September 2022 as VAI.

5
active US DMFs
4
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

  • 1 September 2022 VAI US FDA
  • 13 November 2019 VAI US FDA
  • 20 November 2015 NAI US FDA

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

Registered plants

Site FDA FEI
Birzebbugia, Malta Not on file
Malta, Malta 3008787649

What they file, and where

Molecule Regulators Docs
Dutasteride EDQM, SFDA (Saudi Arabia), US FDA 4
Levonorgestrel EDQM, US FDA 3
Fulvestrant SFDA (Saudi Arabia) 2
Abiraterone US FDA 1
Drospirenone EDQM 1
Fluticasone Furoate SFDA (Saudi Arabia) 1
Umeclidinium Bromide US FDA 1
Vilanterol US FDA 1

Also appears on these molecule pages

Drospirenone API Dutasteride API Levonorgestrel API Umeclidinium API Vilanterol API

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Open risk flags

  • The most recent inspection outcome was VAI, on 1 September 2022.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability