Suppliers / Opocrin

Opocrin

Italy Updated 9 July 2026

Opocrin is an API manufacturer based in Italy. It holds 3 valid CEPs across a filed portfolio of 3 molecules. Its GMP standing is certified by EMA. Its most recent recorded inspection, by US FDA, closed on 25 February 2022 as VAI.

0
active US DMFs
3
valid CEPs
8
registered plants 2 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
3 of 3 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

  • 25 February 2022 VAI US FDA
  • 29 September 2017 VAI US FDA
  • 6 May 2016 VAI US FDA

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

Registered plants

Site FDA FEI
TRINO, Italy Not on file
NONANTOLA, Italy Not on file
Italy, Italy 3009116141
Italy, Italy 3002807810
Corlo Di Formigine, Italy Not on file
Formigine, Italy Not on file

2 further sites are on record.

What they file, and where

Molecule Regulators Docs
Heparin Sodium EDQM 2
Heparin Calcium EDQM 1
Iron SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Heparin API

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA None 1

Questions about Opocrin

Does Opocrin hold a US DMF or a CEP?
Opocrin holds 3 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 Opocrin FDA-registered?
2 sites operated by Opocrin carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Opocrin's last inspection go?
The most recent inspection on record closed on 25 February 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does Opocrin manufacture?
8 registered sites are on record, in Italy (Trino, Nonantola and Italy among others). Every site is listed on this page with the register it came from.
What does Opocrin make?
3 molecules are on record against Opocrin, including Heparin Sodium, Heparin Calcium and Iron. Each links through to that molecule's full manufacturer list.
Which regulators recognise Opocrin's GMP?
Current GMP certificates are on record from 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 25 February 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