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.

active US DMFs

valid CEPs

registered plants 1 with an FDA FEI number

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
MINSA (CR)	1	None
MFDS (Korea)	None	4
ANVISA (Brazil)	None	3
EMA	None	2

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Open risk flags

The most recent inspection outcome was VAI, on 11 November 2022.

Sources on this page

FDA: Drug master files, establishment registration, inspection classifications
EDQM: Certificates of suitability
EudraGMDP and national regulators: GMP certificates