Suppliers / PROCOS

PROCOS

Italy 2 duplicate records merged Updated 9 July 2026

PROCOS is an API 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

Questions about PROCOS

Does PROCOS hold a US DMF or a CEP?
PROCOS holds 20 active US drug master files and 2 valid CEPs. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is PROCOS FDA-registered?
One site operated by PROCOS 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 PROCOS's last inspection go?
The most recent inspection on record closed on 16 September 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 6 inspections are on file.
Where does PROCOS manufacture?
2 registered sites are on record, in Italy (Italy and Cameri). Every site is listed on this page with the register it came from.
What does PROCOS make?
22 molecules are on record against PROCOS, including Pyridostigmine, Memantine, Orphenadrine and Pirfenidone. Each links through to that molecule's full manufacturer list.

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

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

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Sources on this page

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