Suppliers / Cilag

Cilag

Switzerland 2 duplicate records merged Updated 9 July 2026

Cilag is an API and finished-dose manufacturer based in Switzerland. It holds 4 active US drug master files across a filed portfolio of 5 molecules. Its filings concentrate with ARCSA (EC), MINSA (CR) and INVIMA (CO). Its GMP standing is certified by ANVISA (Brazil), EMA and NAFDAC (NG). Its most recent recorded inspection, by US FDA, closed on 5 May 2023 as NAI.

4
active US DMFs
0
valid CEPs
4
registered plants 1 with an FDA FEI number
45
filings across 4 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
7 of 7 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

  • 5 May 2023 NAI US FDA
  • 16 July 2019 VAI US FDA
  • 8 September 2015 NAI US FDA
  • 18 February 2014 VAI US FDA
  • 27 April 2012 VAI US FDA
  • 3 June 2010 VAI US FDA
  • 15 May 2009 VAI US FDA

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

Registered plants

Site FDA FEI
Schaffhausen, United Arab Emirates Not on file
SCHAFFHAUSEN, Switzerland Not on file
Switzerland, Switzerland 3002806695
schaffhausen, Nigeria Not on file

What they file, and where

Molecule Regulators Docs
Cladribine SFDA (Saudi Arabia), US FDA 2
Alcaftadine US FDA 1
Iron US FDA 1
Iron Sucrose SFDA (Saudi Arabia) 1
Remifentanil US FDA 1

Also appears on these molecule pages

Alcaftadine API Cladribine API Ibrutinib finished dose Paliperidone finished dose Remifentanil API Topiramate finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 16 None
MINSA (CR) 15 None
INVIMA (CO) 11 None
NAFDAC (NG) 3 2
ANVISA (Brazil) None 5
EMA None 4

Questions about Cilag

Does Cilag hold a US DMF or a CEP?
Cilag holds 4 active US drug master files. 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 Cilag FDA-registered?
One site operated by Cilag 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 Cilag's last inspection go?
The most recent inspection on record closed on 5 May 2023 as NAI (No Action Indicated: nothing objectionable was found). 7 inspections are on file.
Where does Cilag manufacture?
4 registered sites are on record, in United Arab Emirates, Switzerland and Nigeria (Schaffhausen, Schaffhausen and Switzerland among others). Every site is listed on this page with the register it came from.
What does Cilag make?
5 molecules are on record against Cilag, including Cladribine, Alcaftadine, Iron and Iron Sucrose. Each links through to that molecule's full manufacturer list.
Which regulators recognise Cilag's GMP?
Current GMP certificates are on record from ANVISA (Brazil), EMA and NAFDAC (NG). 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

  • 7 active litigation matters are on record.
  • The most recent inspection outcome was NAI, on 5 May 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