Suppliers / Bipso

Bipso

Germany 82 employees Updated 9 July 2026

Bipso is a finished-dose manufacturer based in Germany. It appears in 4 regulatory filings across 2 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC) and NCELS (KZ). Its GMP standing is certified by ZLG (DE), MFDS (Korea) and ANVISA (Brazil), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 4 May 2022 as VAI.

0
active US DMFs
0
valid CEPs
3
registered plants 1 with an FDA FEI number
4
filings across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 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

  • 4 May 2022 VAI US FDA
  • 7 November 2019 VAI US FDA
  • 17 June 2016 NAI US FDA
  • 11 February 2014 NAI US FDA
  • 10 May 2012 NAI US FDA

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

Registered plants

Site FDA FEI
SINGEN, Germany Not on file
Germany, Germany 3009099058
Singen (Hohentwiel), Germany Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 2 None
NCELS (KZ) 2 None
ZLG (DE) None 6
MFDS (Korea) None 2
ANVISA (Brazil) None 1
EMA None 1

Questions about Bipso

Does Bipso hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Bipso. It does have 4 filings with 2 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Bipso FDA-registered?
One site operated by Bipso 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 Bipso's last inspection go?
The most recent inspection on record closed on 4 May 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Bipso manufacture?
3 registered sites are on record, in Germany (Singen, Germany and Singen (hohentwiel)). Every site is listed on this page with the register it came from.
Which regulators recognise Bipso's GMP?
Current GMP certificates are on record from ZLG (DE), MFDS (Korea), ANVISA (Brazil) 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 4 May 2022.

Comparable suppliers

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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