Suppliers / Cerbios-Pharma

Cerbios-Pharma

Switzerland 164 employees Updated 9 July 2026

Cerbios-Pharma is an API manufacturer based in Switzerland. It holds 8 active US drug master files and 6 valid CEPs across a filed portfolio of 10 molecules. Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 7 March 2024 as VAI.

8
active US DMFs
6
valid CEPs
4
registered plants 1 with an FDA FEI number
6
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
4 of 4 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

  • 7 March 2024 VAI US FDA
  • 27 April 2018 NAI US FDA
  • 20 February 2014 NAI US FDA
  • 30 September 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
Barbengo, Switzerland Not on file
Barbengo, Switzerland Not on file
Switzerland, Switzerland 3002808250
Lugano, Switzerland Not on file

What they file, and where

Molecule Regulators Docs
Calcipotriol EDQM, US FDA 4
Leucovorin Calcium SFDA (Saudi Arabia), US FDA 3
Tiotropium SFDA (Saudi Arabia), US FDA 3
Calcitriol EDQM, US FDA 2
Calcium Folinate EDQM, SFDA (Saudi Arabia) 2
Calcium Folinate Hydrate EDQM 1
Calcium Levofolinate Hydrate EDQM 1
Doxercalciferol US FDA 1
ホリナートカルシウム PMDA (Japan) 1
レボホリナートカルシウム PMDA (Japan) 1

Also appears on these molecule pages

Calcipotriol API Calcitriol API Calcium Folinate API Doxercalciferol API Leucovorin API Tiotropium API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 6 None
EMA None 2
US FDA None 1

Questions about Cerbios-Pharma

Does Cerbios-Pharma hold a US DMF or a CEP?
Cerbios-Pharma holds 8 active US drug master files and 6 valid CEPs. 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 Cerbios-Pharma FDA-registered?
One site operated by Cerbios-Pharma 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 Cerbios-Pharma's last inspection go?
The most recent inspection on record closed on 7 March 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Cerbios-Pharma manufacture?
4 registered sites are on record, in Switzerland (Barbengo, Switzerland and Lugano among others). Every site is listed on this page with the register it came from.
What does Cerbios-Pharma make?
10 molecules are on record against Cerbios-Pharma, including Calcipotriol, Leucovorin Calcium, Tiotropium and Calcitriol. Each links through to that molecule's full manufacturer list.
Which regulators recognise Cerbios-Pharma's GMP?
Current GMP certificates are on record from EMA 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 7 March 2024.

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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