Suppliers / bene pharmaChem GmbH

bene pharmaChem GmbH

Germany Updated 9 July 2026

bene pharmaChem GmbH is an API manufacturer based in Germany. It holds one active US drug master file. Its GMP standing is certified by ZLG (DE). Its most recent recorded inspection, by US FDA, closed on 8 November 2018 as VAI.

1
active US DMFs
0
valid CEPs
2
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

  • 8 November 2018 VAI US FDA
  • 21 May 2014 NAI US FDA
  • 8 July 2011 VAI US FDA
  • 23 October 2008 VAI US FDA

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

Registered plants

Site FDA FEI
Geretsried, Germany Not on file
Germany, Germany 3006803926

What they file, and where

Molecule Regulators Docs
Pentosan Polysulfate Sodium US FDA 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
ZLG (DE) None 4

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Open risk flags

  • The most recent inspection outcome was VAI, on 8 November 2018.

Sources on this page

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