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
Germany, Germany 3003903447
Bernburg (Saale), Germany Not on file
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

Clenbuterol contract manufacturing Gelatin contract manufacturing 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

Questions about Serumwerk Bernburg

Does Serumwerk Bernburg hold a US DMF or a CEP?
Serumwerk Bernburg holds 2 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 Serumwerk Bernburg FDA-registered?
One site operated by Serumwerk Bernburg 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 Serumwerk Bernburg's last inspection go?
The most recent inspection on record closed on 5 June 2015 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 2 inspections are on file.
Where does Serumwerk Bernburg manufacture?
3 registered sites are on record, in Germany (Germany, Bernburg (saale) and Bernburg). Every site is listed on this page with the register it came from.
What does Serumwerk Bernburg make?
2 molecules are on record against Serumwerk Bernburg, including Starches and Hydroxyethyl Starch. Each links through to that molecule's full manufacturer list.
Which regulators recognise Serumwerk Bernburg's GMP?
Current GMP certificates are on record from ZLG (DE) and EMA. 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 5 June 2015.

Comparable suppliers

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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
EudraGMDP and national regulators
GMP certificates