Suppliers / Sever Pharma Solutions AB

Sever Pharma Solutions AB

Sweden 262 employees Updated 9 July 2026

Sever Pharma Solutions AB is a finished-dose manufacturer based in Sweden. It appears in 5 regulatory filings across 3 regulators, without an active US DMF or CEP on file. Its filings concentrate with NPRA (MY), ARCSA (EC) and MINSA (CR). Its GMP standing is certified by EMA, MFDS (Korea) and US FDA. Its most recent recorded inspection, by US FDA, closed on 12 May 2023 as VAI.

0
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
5
filings across 3 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 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

  • 12 May 2023 VAI US FDA
  • 31 March 2023 NAI US FDA
  • 23 November 2017 VAI US FDA
  • 1 June 2016 NAI US FDA
  • 27 March 2014 VAI US FDA

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

Registered plants

Site FDA FEI
Sweden, Sweden 3004620701
Malmo, Sweden Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
NPRA (MY) 2 None
ARCSA (EC) 2 None
MINSA (CR) 1 None
EMA None 4
MFDS (Korea) None 2
US FDA None 1

Questions about Sever Pharma Solutions AB

Does Sever Pharma Solutions AB hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Sever Pharma Solutions AB. It does have 5 filings with 3 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Sever Pharma Solutions AB FDA-registered?
One site operated by Sever Pharma Solutions AB 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 Sever Pharma Solutions AB's last inspection go?
The most recent inspection on record closed on 12 May 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Sever Pharma Solutions AB manufacture?
2 registered sites are on record, in Sweden (Sweden and Malmo). Every site is listed on this page with the register it came from.
Which regulators recognise Sever Pharma Solutions AB's GMP?
Current GMP certificates are on record from EMA, MFDS (Korea) 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 12 May 2023.

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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