Suppliers / Serumwerk Bernburg

Serumwerk Bernburg

Germany 50 employees Updated 9 July 2026

Serumwerk Bernburg is a finished-dose manufacturer based in Germany. It holds 2 valid CEPs across a filed portfolio of 2 molecules. Its filings concentrate with EMA, MPA (SE) and INFARMED (PT). Its GMP standing is certified by ZLG (DE) and EMA. Its most recent recorded inspection, by US FDA, closed on 5 June 2015 as VAI.

0
active US DMFs
2
valid CEPs
3
registered plants 1 with an FDA FEI number
19
filings across 4 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
2 of 2 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

  • 5 June 2015 VAI US FDA
  • 1 December 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
Bernburg (Saale), Germany Not on file
Germany, Germany 3003903447
Bernburg, Germany Not on file

What they file, and where

Molecule Regulators Docs
Starches EDQM 2
Hydroxyethyl Starch SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Salicylic Acid finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA 11 1
MPA (SE) 5 None
INFARMED (PT) 2 None
DMP (NO) 1 None
ZLG (DE) None 12

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Open risk flags

  • The most recent inspection outcome was VAI, on 5 June 2015.

Sources on this page

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