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

Pentosan Polysulfate API

Filings and GMP by regulator

Regulator Filings GMP certificates
ZLG (DE) None 4

Questions about bene pharmaChem GmbH

Does bene pharmaChem GmbH hold a US DMF or a CEP?
bene pharmaChem GmbH 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 bene pharmaChem GmbH FDA-registered?
One site operated by bene pharmaChem GmbH 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 bene pharmaChem GmbH's last inspection go?
The most recent inspection on record closed on 8 November 2018 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does bene pharmaChem GmbH manufacture?
2 registered sites are on record, in Germany (Geretsried and Germany). Every site is listed on this page with the register it came from.
What does bene pharmaChem GmbH make?
1 molecule is on record against bene pharmaChem GmbH, including Pentosan Polysulfate Sodium. Each links through to that molecule's full manufacturer list.
Which regulators recognise bene pharmaChem GmbH's GMP?
Current GMP certificates are on record from ZLG (DE). 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 8 November 2018.

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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