Suppliers / Dipharma Francis

Dipharma Francis

Italy 350 employees Updated 9 July 2026

Dipharma Francis is an API manufacturer based in Italy. It holds 36 active US drug master files and 16 valid CEPs. Its GMP standing is certified by EMA. Its most recent recorded inspection, by US FDA, closed on 2 September 2022 as VAI.

36
active US DMFs
16
valid CEPs
6
registered plants 3 with an FDA FEI number
2
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
3 of 3 confirmed
Inspections
8 of 8 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

  • 2 September 2022 VAI US FDA
  • 15 July 2022 VAI US FDA
  • 25 February 2022 VAI US FDA
  • 13 September 2019 NAI US FDA
  • 8 February 2019 VAI US FDA
  • 25 October 2018 VAI US FDA
  • 20 April 2018 VAI US FDA
  • 23 February 2018 VAI US FDA

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

Registered plants

Site FDA FEI
CARONNO PERTUSELLA, Italy Not on file
Baranzate, Italy Not on file
Mereto Di Tomba, Italy Not on file
Italy, Italy 3001624853
Italy, Italy 3003270894
Italy, Italy 3002806810

What they file, and where

Molecule Regulators Docs
Isosorbide Mononitrate EDQM, SFDA (Saudi Arabia), US FDA 6
Amitriptyline EDQM, US FDA 3
Diclofenac SFDA (Saudi Arabia), US FDA 3
Nifedipine EDQM, US FDA 3
Selegiline EDQM, US FDA 3
Ursodeoxycholic Acid EDQM, SFDA (Saudi Arabia), US FDA 3
Cholic Acid EDQM, US FDA 2
Cilostazol SFDA (Saudi Arabia), US FDA 2
Cyclobenzaprine SFDA (Saudi Arabia), US FDA 2
Fexofenadine US FDA 2
Show all 30 molecules on file
Ibuprofen SFDA (Saudi Arabia), US FDA 2
Isosorbide Dinitrate EDQM 2
Tramadol EDQM, US FDA 2
Triamterene EDQM, US FDA 2
Aminocaproic Acid US FDA 1
Bupropion US FDA 1
Chenodeoxycholic Acid US FDA 1
Cyproheptadine US FDA 1
Dapsone US FDA 1
Dexlansoprazole US FDA 1
Diluted Isosorbide Mononitrate SFDA (Saudi Arabia) 1
Doxepin US FDA 1
Efinaconazole US FDA 1
Etripamil US FDA 1
Fesoterodine US FDA 1
Glyburide SFDA (Saudi Arabia) 1
Isosorbide Dinitrate Diluted SFDA (Saudi Arabia) 1
Modafinil US FDA 1
Nitroglycerin US FDA 1
Nortriptyline US FDA 1

Also appears on these molecule pages

Amitriptyline contract manufacturing Candesartan contract manufacturing Cilostazol API Dexlansoprazole contract manufacturing Diclofenac contract manufacturing Fexofenadine contract manufacturing Glibenclamide contract manufacturing Ibuprofen contract manufacturing Lansoprazole contract manufacturing Lysine contract manufacturing Nifedipine contract manufacturing Piroxicam contract manufacturing
Show 2 more molecule pages
Tramadol API Ursodeoxycholic Acid API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 2 None
EMA None 1

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Open risk flags

  • The most recent inspection outcome was VAI, on 2 September 2022.

Sources on this page

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