Suppliers / AlfaSigma

AlfaSigma

Italy 2 duplicate records merged Updated 9 July 2026

AlfaSigma is a finished-dose manufacturer based in Italy. It appears in 883 regulatory filings across 23 regulators, without an active US DMF or CEP on file. Its filings concentrate with AIFA (IT), EMA and AEMPS (ES). Its GMP standing is certified by ANVISA (Brazil), EMA and MFDS (Korea), among 6 authorities. Its most recent recorded inspection, by US FDA, closed on 26 January 2024 as VAI.

0
active US DMFs
0
valid CEPs
10
registered plants 2 with an FDA FEI number
883
filings across 23 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 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

  • 26 January 2024 VAI US FDA
  • 27 September 2022 VAI US FDA
  • 28 May 2021 VAI US FDA
  • 18 January 2019 VAI US FDA
  • 21 June 2018 VAI US FDA
  • 10 November 2015 VAI US FDA
  • 3 July 2015 VAI US FDA
  • 16 September 2011 VAI US FDA

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

Registered plants

Site FDA FEI
Alanno, United Arab Emirates Not on file
Zofingen, Switzerland Not on file
Campredo, Spain Not on file
ALANNO, Italy Not on file
PESCARA, Italy Not on file
Italy, Italy 3002808171

4 further sites are on record.

Filings and GMP by regulator

Regulator Filings GMP certificates
AIFA (IT) 497 None
EMA 160 3
AEMPS (ES) 43 None
ANSM (FR) 37 None
INFARMED (PT) 35 None
FAMHP (BE) 18 None
ANVISA (Brazil) None 5
MFDS (Korea) None 2
MINPROMTORG (RU) None 2
EAEU_EEC None 1
US FDA None 1

Questions about AlfaSigma

Does AlfaSigma hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for AlfaSigma. It does have 883 filings with 23 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is AlfaSigma FDA-registered?
2 sites operated by AlfaSigma carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did AlfaSigma's last inspection go?
The most recent inspection on record closed on 26 January 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does AlfaSigma manufacture?
10 registered sites are on record, in United Arab Emirates, Switzerland, Spain and Italy (Alanno, Zofingen and Campredo among others). Every site is listed on this page with the register it came from.
Which regulators recognise AlfaSigma's GMP?
Current GMP certificates are on record from ANVISA (Brazil), EMA, MFDS (Korea), MINPROMTORG (RU), EEC (Eurasian Economic Union) and 1 more. 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 26 January 2024.

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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