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.

active US DMFs

valid CEPs

registered plants 2 with an FDA FEI number

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

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Open risk flags

The most recent inspection outcome was VAI, on 25 February 2022.

Sources on this page

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