Suppliers / Laboratorium Ofichem

Laboratorium Ofichem

Netherlands Updated 9 July 2026

Laboratorium Ofichem is an API and finished-dose manufacturer based in Netherlands. It holds 2 active US drug master files across a filed portfolio of 2 molecules. Its filings concentrate with EMA, MINSA (CR) and NMPA (CN). Its GMP standing is certified by ZLG (DE), US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 12 October 2023 as VAI.

2
active US DMFs
0
valid CEPs
3
registered plants 1 with an FDA FEI number
21
filings across 3 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
0 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

  • 12 October 2023 VAI US FDA
  • 18 September 2019 NAI US FDA
  • 17 December 2015 VAI US FDA

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

Registered plants

Site FDA FEI
Dusseldorf, Germany Not on file
Duesseldorf, Germany Not on file
Netherlands, Netherlands 1000286391

What they file, and where

Molecule Regulators Docs
Dimethyl Fumarate US FDA 1
Histamine Phosphate US FDA 1

Also appears on these molecule pages

Adapalene finished dose Dimethyl API Ivermectin finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA 19 1
MINSA (CR) 1 None
NMPA (CN) 1 None
ZLG (DE) None 4
US FDA None 1

Questions about Laboratorium Ofichem

Does Laboratorium Ofichem hold a US DMF or a CEP?
Laboratorium Ofichem holds 2 active US drug master files. 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 Laboratorium Ofichem FDA-registered?
One site operated by Laboratorium Ofichem 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 Laboratorium Ofichem's last inspection go?
The most recent inspection on record closed on 12 October 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does Laboratorium Ofichem manufacture?
3 registered sites are on record, in Germany and Netherlands (Dusseldorf, Duesseldorf and Netherlands). Every site is listed on this page with the register it came from.
What does Laboratorium Ofichem make?
2 molecules are on record against Laboratorium Ofichem, including Dimethyl Fumarate and Histamine Phosphate. Each links through to that molecule's full manufacturer list.
Which regulators recognise Laboratorium Ofichem's GMP?
Current GMP certificates are on record from ZLG (DE), US FDA 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 12 October 2023.

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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