Labtec

Germany 158 employees Updated 9 July 2026

Labtec is a finished-dose manufacturer based in Germany. It appears in 2 regulatory filings across 1 regulator, without an active US DMF or CEP on file. Its GMP standing is certified by ZLG (DE), EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 25 May 2023 as NAI.

active US DMFs

valid CEPs

registered plants 2 with an FDA FEI number

filings across 1 regulators

These figures were checked against the regulators' own files on 25 July 2026

Plants

2 of 2 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

25 May 2023 NAI US FDA
2 February 2016 VAI US FDA
29 January 2016 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	3010375003
Hamburg, Germany	Not on file
Langenfeld (Rheinland), Germany	Not on file
Germany, Germany	3010969322

Filings and GMP by regulator

Regulator	Filings	GMP certificates
ARCSA (EC)	2	None
ZLG (DE)	None	8
EMA	None	2
US FDA	None	1

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Open risk flags

The most recent inspection outcome was NAI, on 25 May 2023.

Sources on this page

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