Suppliers / Cambrex Profarmaco Milano

Cambrex Profarmaco Milano

Italy 2 duplicate records merged Updated 9 July 2026

Cambrex Profarmaco Milano is an API manufacturer based in Italy. It holds 94 active US drug master files and 18 valid CEPs. Its most recent recorded inspection, by US FDA, closed on 11 November 2022 as NAI.

94
active US DMFs
18
valid CEPs
2
registered plants 1 with an FDA FEI number
8
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
7 of 7 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 11 November 2022 NAI US FDA
  • 1 October 2021 VAI US FDA
  • 7 May 2019 NAI US FDA
  • 19 May 2017 VAI US FDA
  • 6 November 2015 VAI US FDA
  • 25 March 2011 NAI US FDA
  • 31 March 2009 OAI US FDA

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

Registered plants

Site FDA FEI
Italy, Italy 3003723076
Paullo, Italy Not on file

What they file, and where

Molecule Regulators Docs
Epinephrine EDQM, SFDA (Saudi Arabia), US FDA 8
Midazolam EDQM, SFDA (Saudi Arabia), US FDA 8
Norepinephrine EDQM, SFDA (Saudi Arabia), US FDA 5
Chlordiazepoxide US FDA 4
Clozapine EDQM, SFDA (Saudi Arabia), US FDA 4
Cysteamine US FDA 4
Lacosamide EDQM, SFDA (Saudi Arabia), US FDA 4
Alprazolam EDQM, US FDA 3
Amiodarone EDQM, US FDA 3
Glyburide SFDA (Saudi Arabia), US FDA 3
Show all 30 molecules on file
Hydrochlorothiazide EDQM, US FDA 3
Lorazepam EDQM, US FDA 3
Rifaximin EDQM, US FDA 3
Sodium Picosulfate EDQM, US FDA 3
Sotalol SFDA (Saudi Arabia), US FDA 3
Zolpidem EDQM, US FDA 3
Albuterol US FDA 2
Bisacodyl US FDA 2
Chlorothiazide US FDA 2
Clobazam US FDA 2
Clonazepam US FDA 2
Clorazepic Acid US FDA 2
Cromoglicic Acid US FDA 2
Dapagliflozin US FDA 2
Diazepam US FDA 2
Diltiazem US FDA 2
Eltrombopag US FDA 2
Estazolam US FDA 2
Flurazepam US FDA 2
Glipizide US FDA 2

Also appears on these molecule pages

Albuterol API Alprazolam API Amiodarone API Bisacodyl API Chlordiazepoxide API Chlorothiazide API Clobazam API Clonazepam API Clozapine API Cromoglicic Acid API Cysteamine API Diazepam API
Show 23 more molecule pages
Diltiazem API Eltrombopag API Epinephrine API Glibenclamide API Glipizide API Glyburide API Hydrochlorothiazide API Labetalol API Lacosamide API Lorazepam API Midazolam API Norepinephrine API Olaparib API Oxazepam API Pirfenidone API Raloxifene API Rifaximin API Salbutamol API Sodium Cromoglicate API Sotalol API Terbutaline API Zolpidem API Dapagliflozin API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 8 None

Questions about Cambrex Profarmaco Milano

Does Cambrex Profarmaco Milano hold a US DMF or a CEP?
Cambrex Profarmaco Milano holds 94 active US drug master files and 18 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 Cambrex Profarmaco Milano FDA-registered?
One site operated by Cambrex Profarmaco Milano 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 Cambrex Profarmaco Milano's last inspection go?
The most recent inspection on record closed on 11 November 2022 as NAI (No Action Indicated: nothing objectionable was found). 7 inspections are on file, of which 1 closed as OAI.
Where does Cambrex Profarmaco Milano manufacture?
2 registered sites are on record, in Italy (Italy and Paullo). Every site is listed on this page with the register it came from.
What does Cambrex Profarmaco Milano make?
30 molecules are on record against Cambrex Profarmaco Milano, including Epinephrine, Midazolam, Norepinephrine and Chlordiazepoxide. Each links through to that molecule's full manufacturer list.
Where does Cambrex Profarmaco Milano file?
Filings are on record with MINSA (CR), 8 in total.

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

  • 4 active litigation matters are on record.
  • The most recent inspection outcome was NAI, on 11 November 2022.

Comparable suppliers

Olon shares 11 molecules Apitoria Pharma shares 9 molecules F.I.S. Fabbrica Italiana Sintetici shares 9 molecules Centaur Pharmaceuticals shares 8 molecules Alivus Life Sciences shares 7 molecules

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