Suppliers / Ibsa Institut Biochimique

Ibsa Institut Biochimique

Switzerland Updated 9 July 2026

Ibsa Institut Biochimique is a finished-dose manufacturer based in Switzerland. It appears in 180 regulatory filings across 11 regulators, without an active US DMF or CEP on file. Its filings concentrate with SWISSMEDIC (CH), EDE (AE) and RAMA (GE). Its GMP standing is certified by EMA and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 24 March 2023 as VAI.

0
active US DMFs
0
valid CEPs
10
registered plants 1 with an FDA FEI number
180
filings across 11 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
8 of 8 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

  • 24 March 2023 VAI US FDA
  • 28 March 2019 NAI US FDA
  • 22 June 2018 VAI US FDA
  • 8 July 2016 NAI US FDA
  • 30 July 2015 NAI US FDA
  • 27 September 2013 NAI US FDA
  • 7 July 2011 NAI US FDA
  • 12 May 2010 NAI US FDA

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

Registered plants

Site FDA FEI
Lugano, United Arab Emirates Not on file
pazzallo, United Arab Emirates Not on file
Lugano, United Arab Emirates Not on file
LAMONE, Switzerland Not on file
Montagnola, Switzerland Not on file
Pazzallo, Switzerland Not on file

4 further sites are on record.

Filings and GMP by regulator

Regulator Filings GMP certificates
SWISSMEDIC (CH) 133 None
EDE (AE) 11 None
RAMA (GE) 9 None
ARCSA (EC) 7 None
DPM (TN) 7 None
Health Canada 5 None
EMA None 8
ANVISA (Brazil) None 3

Questions about Ibsa Institut Biochimique

Does Ibsa Institut Biochimique hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Ibsa Institut Biochimique. It does have 180 filings with 11 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Ibsa Institut Biochimique FDA-registered?
One site operated by Ibsa Institut Biochimique 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 Ibsa Institut Biochimique's last inspection go?
The most recent inspection on record closed on 24 March 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Ibsa Institut Biochimique manufacture?
10 registered sites are on record, in United Arab Emirates and Switzerland (Lugano, Pazzallo and Lamone among others). Every site is listed on this page with the register it came from.
Which regulators recognise Ibsa Institut Biochimique's GMP?
Current GMP certificates are on record from EMA and ANVISA (Brazil). 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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  • The most recent inspection outcome was VAI, on 24 March 2023.

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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