Suppliers / PROCOS

PROCOS

Italy 2 duplicate records merged Updated 9 July 2026

PROCOS is a contract manufacturer based in Italy. It holds 20 active US drug master files and 2 valid CEPs across a filed portfolio of 22 molecules. Its most recent recorded inspection, by US FDA, closed on 16 September 2022 as VAI.

20
active US DMFs
2
valid CEPs
2
registered plants 1 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
6 of 6 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 16 September 2022 VAI US FDA
  • 1 February 2019 VAI US FDA
  • 19 May 2017 VAI US FDA
  • 26 February 2016 VAI US FDA
  • 1 August 2013 NAI US FDA
  • 19 May 2010 VAI US FDA

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

Registered plants

Site FDA FEI
Italy, Italy 3002807938
Cameri, Italy Not on file

What they file, and where

Molecule Regulators Docs
Pyridostigmine EDQM, SFDA (Saudi Arabia), US FDA 3
Memantine SFDA (Saudi Arabia), US FDA 2
Orphenadrine SFDA (Saudi Arabia), US FDA 2
Pirfenidone EDQM, US FDA 2
Alverine SFDA (Saudi Arabia) 1
Candesartan Cilexetil SFDA (Saudi Arabia) 1
Carglumic Acid US FDA 1
Clofedanol US FDA 1
Dalfampridine US FDA 1
Efinaconazole US FDA 1
Show all 22 molecules on file
Embutramide US FDA 1
Felbamate US FDA 1
Guanfacine US FDA 1
Iloperidone US FDA 1
Istradefylline US FDA 1
Labetalol US FDA 1
Lofexidine US FDA 1
Lurasidone US FDA 1
Midostaurin US FDA 1
Phenelzine US FDA 1
Propafenone US FDA 1
Trospium US FDA 1

Also appears on these molecule pages

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Open risk flags

  • 1 active litigation matter is on record.
  • The most recent inspection outcome was VAI, on 16 September 2022.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability