Suppliers / Chemische Fabrik Berg

Chemische Fabrik Berg

Germany Updated 9 July 2026

Chemische Fabrik Berg is an API manufacturer based in Germany. It holds 5 active US drug master files and 10 valid CEPs across a filed portfolio of 14 molecules. Its GMP standing is certified by ZLG (DE) and US FDA. Its most recent recorded inspection, by US FDA, closed on 16 May 2024 as VAI.

5
active US DMFs
10
valid CEPs
3
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
4 of 4 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 16 May 2024 VAI US FDA
  • 29 June 2018 VAI US FDA
  • 15 May 2015 VAI US FDA
  • 26 April 2012 VAI US FDA

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

Registered plants

Site FDA FEI
Bitterfeld Wolfen, Germany Not on file
Bitterfeld-Wolfen, Germany Not on file
Germany, Germany 3003004618

What they file, and where

Molecule Regulators Docs
Dimenhydrinate EDQM, SFDA (Saudi Arabia) 2
Doxazosin Mesilate EDQM 2
Tamoxifen Citrate EDQM 2
Butalbital US FDA 1
Fluorouracil SFDA (Saudi Arabia) 1
Hydroxyzine US FDA 1
Methenamine US FDA 1
Pentobarbital EDQM 1
Phenobarbital EDQM 1
Phentermine US FDA 1
Show all 14 molecules on file
Propylthiouracil US FDA 1
Terazosin EDQM 1
Thiopental Sodium And Sodium Carbonate EDQM 1
Xylometazoline EDQM 1

Also appears on these molecule pages

Chlorphenamine contract manufacturing Chlorpheniramine contract manufacturing Dimenhydrinate contract manufacturing Dimethyl contract manufacturing Doxazosin contract manufacturing Doxazosin Mesilate API Fluorouracil contract manufacturing Hydroxyzine contract manufacturing Methenamine contract manufacturing Phenobarbital contract manufacturing Phentermine contract manufacturing Phenylephrine contract manufacturing
Show 4 more molecule pages
Propylthiouracil API Tamoxifen contract manufacturing Terazosin contract manufacturing Xylometazoline contract manufacturing

Filings and GMP by regulator

Regulator Filings GMP certificates
ZLG (DE) None 4
US FDA None 1

Questions about Chemische Fabrik Berg

Does Chemische Fabrik Berg hold a US DMF or a CEP?
Chemische Fabrik Berg holds 5 active US drug master files and 10 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 Chemische Fabrik Berg FDA-registered?
One site operated by Chemische Fabrik Berg 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 Chemische Fabrik Berg's last inspection go?
The most recent inspection on record closed on 16 May 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Chemische Fabrik Berg manufacture?
3 registered sites are on record, in Germany (Bitterfeld Wolfen, Bitterfeld-wolfen and Germany). Every site is listed on this page with the register it came from.
What does Chemische Fabrik Berg make?
14 molecules are on record against Chemische Fabrik Berg, including Dimenhydrinate, Doxazosin Mesilate, Tamoxifen Citrate and Butalbital. Each links through to that molecule's full manufacturer list.
Which regulators recognise Chemische Fabrik Berg's GMP?
Current GMP certificates are on record from ZLG (DE) 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 16 May 2024.

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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