Suppliers / Cambrex Karlskoga AB

Cambrex Karlskoga AB

Sweden 218 employees Updated 9 July 2026

Cambrex Karlskoga AB is an API manufacturer based in Sweden. It holds 5 active US drug master files and 9 valid CEPs across a filed portfolio of 7 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 24 May 2024 as VAI.

5
active US DMFs
9
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
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 24 May 2024 VAI US FDA
  • 4 April 2019 VAI US FDA
  • 27 May 2016 VAI US FDA
  • 21 March 2014 VAI US FDA
  • 3 February 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
Karlskoga, Sweden Not on file
Sweden, Sweden 3001686607

What they file, and where

Molecule Regulators Docs
Bupivacaine EDQM, US FDA 4
Lidocaine EDQM, US FDA 4
Mesalazine EDQM, SFDA (Saudi Arabia) 3
Rivastigmine EDQM, US FDA 3
Benzoyl Peroxide EDQM, SFDA (Saudi Arabia) 2
Berotralstat Dihydrochloride SFDA (Saudi Arabia) 1
Hydrous Benzoyl Peroxide SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Benzoyl Peroxide API Lidocaine API Mesalamine API Mesalazine API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

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Open risk flags

  • The most recent inspection outcome was VAI, on 24 May 2024.

Sources on this page

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