Suppliers / Chiesi Farmaceutici

Chiesi Farmaceutici

Italy 188 employees Updated 9 July 2026

Chiesi Farmaceutici is a finished-dose manufacturer based in Italy. It appears in 642 regulatory filings across 20 regulators, without an active US DMF or CEP on file. Its filings concentrate with AIFA (IT), EMA and FAMHP (BE). Its GMP standing is certified by ANVISA (Brazil), EMA and MFDS (Korea), among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 29 September 2023 as VAI.

0
active US DMFs
0
valid CEPs
7
registered plants 1 with an FDA FEI number
642
filings across 20 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 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

  • 29 September 2023 VAI US FDA
  • 23 November 2018 VAI US FDA
  • 26 July 2018 VAI US FDA
  • 29 July 2016 VAI US FDA
  • 8 July 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
Parma, United Arab Emirates Not on file
PARMA, Italy Not on file
CAMPI BISENZIO (FI), Italy Not on file
43122 PARMA, Italy Not on file
Italy, Italy 3002806655
Cepim, Italy Not on file

1 further sites are on record.

Filings and GMP by regulator

Regulator Filings GMP certificates
AIFA (IT) 213 None
EMA 94 3
FAMHP (BE) 66 None
DIGEMAPS (DO) 61 None
INFARMED (PT) 48 None
MPA (SE) 42 None
ANVISA (Brazil) None 3
MFDS (Korea) None 2
US FDA None 1
TMDA (TZ) None 1

Questions about Chiesi Farmaceutici

Does Chiesi Farmaceutici hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Chiesi Farmaceutici. It does have 642 filings with 20 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Chiesi Farmaceutici FDA-registered?
One site operated by Chiesi Farmaceutici 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 Chiesi Farmaceutici's last inspection go?
The most recent inspection on record closed on 29 September 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Chiesi Farmaceutici manufacture?
7 registered sites are on record, in United Arab Emirates and Italy (Parma, Parma and Campi Bisenzio (fi) among others). Every site is listed on this page with the register it came from.
Which regulators recognise Chiesi Farmaceutici's GMP?
Current GMP certificates are on record from ANVISA (Brazil), EMA, MFDS (Korea), US FDA and TMDA (TZ). 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 29 September 2023.

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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