Suppliers / Richter BioLogics

Richter BioLogics

Germany Updated 9 July 2026

Richter BioLogics is a finished-dose manufacturer based in Germany. It appears in 1 regulatory filing across 1 regulator, without an active US DMF or CEP on file. Its GMP standing is certified by ZLG (DE). Its most recent recorded inspection, by US FDA, closed on 30 June 2022 as VAI.

0
active US DMFs
0
valid CEPs
5
registered plants 3 with an FDA FEI number
1
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
3 of 3 confirmed
Inspections
3 of 3 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 30 June 2022 VAI US FDA
  • 24 March 2022 VAI US FDA
  • 28 August 2019 VAI US FDA

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

Registered plants

Site FDA FEI
Bovenau, Germany Not on file
Hannover, Germany Not on file
Germany, Germany 3009883634
Germany, Germany 3006674995
Germany, Germany 3006553942

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 1 None
ZLG (DE) None 8

Questions about Richter BioLogics

Does Richter BioLogics hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Richter BioLogics. It does have 1 filing with one regulator, so it is registered, just not with the two strong registers buyers usually screen on.
Is Richter BioLogics FDA-registered?
3 sites operated by Richter BioLogics carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Richter BioLogics's last inspection go?
The most recent inspection on record closed on 30 June 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does Richter BioLogics manufacture?
5 registered sites are on record, in Germany (Bovenau, Hannover and Germany among others). Every site is listed on this page with the register it came from.
Which regulators recognise Richter BioLogics'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 30 June 2022.

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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