Suppliers / HERBRAND PharmaChemicals

HERBRAND PharmaChemicals

Germany 7 employees Updated 9 July 2026

HERBRAND PharmaChemicals is an API manufacturer based in Germany. It holds one active US drug master file. Its filings concentrate with ANSM (FR) and EMA. Its GMP standing is certified by ZLG (DE) and EMA. Its most recent recorded inspection, by US FDA, closed on 9 December 2022 as VAI.

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

  • 9 December 2022 VAI US FDA
  • 17 June 2016 VAI US FDA
  • 15 June 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
Germany, Germany 3003310388
Baden-Wuerttemberg, Germany Not on file
Gengenbach, Germany Not on file
Murchin, Germany Not on file
Mecklenburg-Western-Pommerania, Germany Not on file

What they file, and where

Molecule Regulators Docs
Propylthiouracil US FDA 1

Also appears on these molecule pages

Propylthiouracil API

Filings and GMP by regulator

Regulator Filings GMP certificates
ANSM (FR) 1 None
EMA 1 4
ZLG (DE) None 36

Questions about HERBRAND PharmaChemicals

Does HERBRAND PharmaChemicals hold a US DMF or a CEP?
HERBRAND PharmaChemicals holds 1 active US drug master file. 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 HERBRAND PharmaChemicals FDA-registered?
One site operated by HERBRAND PharmaChemicals 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 HERBRAND PharmaChemicals's last inspection go?
The most recent inspection on record closed on 9 December 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does HERBRAND PharmaChemicals manufacture?
5 registered sites are on record, in Germany (Germany, Baden-wuerttemberg and Gengenbach among others). Every site is listed on this page with the register it came from.
What does HERBRAND PharmaChemicals make?
1 molecule is on record against HERBRAND PharmaChemicals, including Propylthiouracil. Each links through to that molecule's full manufacturer list.
Which regulators recognise HERBRAND PharmaChemicals'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 9 December 2022.

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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