Kedrion

Italy Updated 9 July 2026

Kedrion is a finished-dose manufacturer based in Italy. It appears in 277 regulatory filings across 23 regulators, without an active US DMF or CEP on file. Its filings concentrate with AIFA (IT), EMA and INFARMED (PT). Its GMP standing is certified by EMA, ANVISA (Brazil) and MINPROMTORG (RU), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 30 April 2025 as NAI.

active US DMFs

valid CEPs

registered plants 2 with an FDA FEI number

277

filings across 23 regulators

These figures were checked against the regulators' own files on 25 July 2026

Plants

2 of 2 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

30 April 2025 NAI US FDA
24 June 2022 VAI US FDA
16 September 2016 VAI US FDA
27 June 2014 VAI US FDA
18 April 2012 VAI US FDA

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

Registered plants

Site	FDA FEI
Gallicano, United Arab Emirates	Not on file
Sant'antimo (NA), United Arab Emirates	Not on file
GALLICANO, Italy	Not on file
SIENA, Italy	Not on file
SANT'ANTIMO, Italy	Not on file
BARGA, Italy	Not on file

6 further sites are on record.

Filings and GMP by regulator

Regulator	Filings	GMP certificates
AIFA (IT)	112	None
EMA	49	5
INFARMED (PT)	23	None
RAMA (GE)	14	None
DPM (TN)	9	None
DAV (Vietnam)	9	None
ANVISA (Brazil)	None	3
MINPROMTORG (RU)	None	2
US FDA	None	1

Questions about Kedrion

Does Kedrion hold a US DMF or a CEP?

No active US drug master file or valid CEP is on record for Kedrion. It does have 277 filings with 23 regulators, so it is registered, just not with the two strong registers buyers usually screen on.

Is Kedrion FDA-registered?

2 sites operated by Kedrion 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 Kedrion's last inspection go?

The most recent inspection on record closed on 30 April 2025 as NAI (No Action Indicated: nothing objectionable was found). 5 inspections are on file.

Where does Kedrion manufacture?

12 registered sites are on record, in United Arab Emirates, Italy and Mexico (Gallicano, Sant'antimo (na) and Gallicano among others). Every site is listed on this page with the register it came from.

Which regulators recognise Kedrion's GMP?

Current GMP certificates are on record from EMA, ANVISA (Brazil), MINPROMTORG (RU) and US FDA. 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 NAI, on 30 April 2025.

Comparable suppliers

A. Menarini Manufacturing Logistics And Services also in Italy Adienne also in Italy AlfaSigma also in Italy Aptuit also in Italy Avara Liscate Pharmaceutical Services also in Italy

Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

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