Suppliers / Fisiopharma

Fisiopharma

Italy 90 employees Updated 9 July 2026

Fisiopharma is a finished-dose manufacturer based in Italy. It appears in 101 regulatory filings across 4 regulators, without an active US DMF or CEP on file. Its filings concentrate with AIFA (IT), EMA and EDE (AE). Its GMP standing is certified by EMA, MFDS (Korea) and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 21 June 2022 as NAI.

0
active US DMFs
0
valid CEPs
5
registered plants 1 with an FDA FEI number
101
filings across 4 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 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

  • 21 June 2022 NAI US FDA
  • 27 September 2019 OAI US FDA
  • 26 September 2016 NAI US FDA

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

Registered plants

Site FDA FEI
Palomonte, United Arab Emirates Not on file
PALOMONTE (SA), Italy Not on file
PALOMONTE, Italy Not on file
Palomonte, Italy Not on file
Italy, Italy 3006435023

Filings and GMP by regulator

Regulator Filings GMP certificates
AIFA (IT) 83 None
EMA 12 2
EDE (AE) 3 None
NPRA (MY) 3 None
MFDS (Korea) None 2
ANVISA (Brazil) None 1

Questions about Fisiopharma

Does Fisiopharma hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Fisiopharma. It does have 101 filings with 4 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Fisiopharma FDA-registered?
One site operated by Fisiopharma 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 Fisiopharma's last inspection go?
The most recent inspection on record closed on 21 June 2022 as NAI (No Action Indicated: nothing objectionable was found). 3 inspections are on file, of which 1 closed as OAI.
Where does Fisiopharma manufacture?
5 registered sites are on record, in United Arab Emirates and Italy (Palomonte, Palomonte (sa) and Palomonte among others). Every site is listed on this page with the register it came from.
Which regulators recognise Fisiopharma's GMP?
Current GMP certificates are on record from EMA, MFDS (Korea) and ANVISA (Brazil). 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.

Comparing suppliers?

Choose your molecules and target markets. Fisiopharma comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Open risk flags

  • The most recent inspection outcome was NAI, on 21 June 2022.

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