Suppliers / Laborchemie Apolda

Laborchemie Apolda

Germany Updated 9 July 2026

Laborchemie Apolda is an API manufacturer based in Germany. It holds 5 active US drug master files across a filed portfolio of 4 molecules. Its GMP standing is certified by ZLG (DE) and US FDA. Its most recent recorded inspection, by US FDA, closed on 27 March 2025 as VAI.

5
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

  • 27 March 2025 VAI US FDA
  • 31 August 2018 VAI US FDA
  • 27 June 2014 VAI US FDA
  • 30 June 2011 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 3003585629
Apolda, Germany Not on file

What they file, and where

Molecule Regulators Docs
Penicillamine US FDA 2
Bendamustine US FDA 1
Dienogest US FDA 1
Menglytate US FDA 1

Also appears on these molecule pages

Bendamustine API Dienogest API Penicillamine API

Filings and GMP by regulator

Regulator Filings GMP certificates
ZLG (DE) None 4
US FDA None 1

Questions about Laborchemie Apolda

Does Laborchemie Apolda hold a US DMF or a CEP?
Laborchemie Apolda holds 5 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 Laborchemie Apolda FDA-registered?
One site operated by Laborchemie Apolda 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 Laborchemie Apolda's last inspection go?
The most recent inspection on record closed on 27 March 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Laborchemie Apolda manufacture?
2 registered sites are on record, in Germany (Germany and Apolda). Every site is listed on this page with the register it came from.
What does Laborchemie Apolda make?
4 molecules are on record against Laborchemie Apolda, including Penicillamine, Bendamustine, Dienogest and Menglytate. Each links through to that molecule's full manufacturer list.
Which regulators recognise Laborchemie Apolda's GMP?
Current GMP certificates are on record from ZLG (DE) and US FDA. 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 27 March 2025.

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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