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 3003270894
Italy, Italy 3002806810
Italy, Italy 3001624853

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

Aminocaproic Acid API Amitriptyline contract manufacturing Benserazide contract manufacturing Bupropion contract manufacturing Candesartan contract manufacturing Cholic Acid API Cilostazol API Crisaborole contract manufacturing Cyclobenzaprine contract manufacturing Dapsone contract manufacturing Dexlansoprazole contract manufacturing Diclofenac contract manufacturing
Show 21 more molecule pages
Doxepin contract manufacturing Efinaconazole contract manufacturing Fesoterodine contract manufacturing Fexofenadine contract manufacturing Glibenclamide contract manufacturing Glyburide contract manufacturing Ibuprofen contract manufacturing Lansoprazole contract manufacturing Lysine contract manufacturing Modafinil contract manufacturing Nifedipine contract manufacturing Nitroglycerin contract manufacturing Nortriptyline contract manufacturing Pirfenidone contract manufacturing Piroxicam contract manufacturing Rufinamide contract manufacturing Selegiline contract manufacturing Tramadol API Ursodeoxycholic Acid API Vortioxetine contract manufacturing Zonisamide contract manufacturing

Filings and GMP by regulator

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

Questions about Dipharma Francis

Does Dipharma Francis hold a US DMF or a CEP?
Dipharma Francis holds 36 active US drug master files and 16 valid CEPs. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Dipharma Francis FDA-registered?
3 sites operated by Dipharma Francis 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 Dipharma Francis's last inspection go?
The most recent inspection on record closed on 2 September 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Dipharma Francis manufacture?
6 registered sites are on record, in Italy (Caronno Pertusella, Baranzate and Mereto Di Tomba among others). Every site is listed on this page with the register it came from.
What does Dipharma Francis make?
30 molecules are on record against Dipharma Francis, including Isosorbide Mononitrate, Amitriptyline, Diclofenac and Nifedipine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Dipharma Francis's GMP?
Current GMP certificates are on record from EMA. 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 VAI, on 2 September 2022.

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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