Suppliers / Baccinex

Baccinex

Switzerland 37 employees Updated 9 July 2026

Baccinex is a finished-dose manufacturer based in Switzerland. It appears in 1 regulatory filing across 1 regulator, without an active US DMF or CEP on file. Its GMP standing is certified by EMA. Its most recent recorded inspection, by US FDA, closed on 28 October 2022 as VAI.

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

  • 28 October 2022 VAI US FDA

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

Registered plants

Site FDA FEI
COURROUX, Switzerland Not on file
Switzerland, Switzerland 3007272813

Filings and GMP by regulator

Regulator Filings GMP certificates
INVIMA (CO) 1 None
EMA None 1

Questions about Baccinex

Does Baccinex hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Baccinex. It does have 1 filing with one regulator, so it is registered, just not with the two strong registers buyers usually screen on.
Is Baccinex FDA-registered?
One site operated by Baccinex 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 Baccinex's last inspection go?
The most recent inspection on record closed on 28 October 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 1 inspection is on file.
Where does Baccinex manufacture?
2 registered sites are on record, in Switzerland (Courroux and Switzerland). Every site is listed on this page with the register it came from.
Which regulators recognise Baccinex's GMP?
Current GMP certificates are on record from 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 28 October 2022.

Comparable suppliers

Acino Pharma also in Switzerland Alpex Pharma also in Switzerland Bracco Suisse also in Switzerland Drossapharm also in Switzerland F.Hoffmann-La Roche also in Switzerland

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