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 MFDS (Korea), EMA 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

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Open risk flags

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

Sources on this page

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