Suppliers / Cosmo

Cosmo

Italy Updated 9 July 2026

Cosmo is a finished-dose manufacturer based in Italy. It appears in 30 regulatory filings across 8 regulators, without an active US DMF or CEP on file. Its filings concentrate with NPRA (MY), EDA (EG) and INVIMA (CO). Its GMP standing is certified by MFDS (Korea), ANVISA (Brazil) and EMA. Its most recent recorded inspection, by US FDA, closed on 11 November 2022 as VAI.

0
active US DMFs
0
valid CEPs
6
registered plants 1 with an FDA FEI number
30
filings across 8 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

  • 11 November 2022 VAI US FDA
  • 2 February 2018 VAI US FDA
  • 8 July 2015 VAI US FDA
  • 18 July 2013 NAI US FDA
  • 11 November 2011 NAI US FDA

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

Registered plants

Site FDA FEI
Laniate (Milano), United Arab Emirates Not on file
Lainate (Milano), United Arab Emirates Not on file
MILANO (MILAO), Italy Not on file
Lainate, Italy Not on file
Italy, Italy 3004504760
Azeitão, Portugal Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
NPRA (MY) 9 None
EDA (EG) 8 None
INVIMA (CO) 4 None
EDE (AE) 4 None
JFDA (JO) 2 None
ARCSA (EC) 1 None
MFDS (Korea) None 4
ANVISA (Brazil) None 3
EMA None 2

Questions about Cosmo

Does Cosmo hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Cosmo. It does have 30 filings with 8 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Cosmo FDA-registered?
One site operated by Cosmo 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 Cosmo's last inspection go?
The most recent inspection on record closed on 11 November 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Cosmo manufacture?
6 registered sites are on record, in United Arab Emirates, Italy and Portugal (Laniate (milano), Lainate (milano) and Milano (milao) among others). Every site is listed on this page with the register it came from.
Which regulators recognise Cosmo's GMP?
Current GMP certificates are on record from MFDS (Korea), ANVISA (Brazil) and EMA. 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 11 November 2022.

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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