Suppliers / Industriale Chimica

Industriale Chimica

Italy 2 duplicate records merged Updated 9 July 2026

Industriale Chimica is an API manufacturer based in Italy. It holds 40 active US drug master files and 31 valid CEPs. Its most recent recorded inspection, by US FDA, closed on 2 September 2022 as VAI.

40
active US DMFs
31
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
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 2 September 2022 VAI US FDA
  • 21 September 2018 VAI US FDA
  • 4 August 2017 VAI US FDA
  • 14 February 2014 NAI US FDA
  • 8 September 2011 NAI US FDA

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

Registered plants

Site FDA FEI
Saronno, Italy Not on file
Italy, Italy 3001734129

What they file, and where

Molecule Regulators Docs
Abiraterone SFDA (Saudi Arabia), US FDA 6
Drospirenone EDQM, SFDA (Saudi Arabia), US FDA 5
Desogestrel EDQM, SFDA (Saudi Arabia), US FDA 4
Dienogest EDQM, SFDA (Saudi Arabia), US FDA 4
Eplerenone EDQM, US FDA 4
Ethinylestradiol EDQM, SFDA (Saudi Arabia), US FDA 4
Fulvestrant EDQM, SFDA (Saudi Arabia), US FDA 4
Levonorgestrel EDQM, SFDA (Saudi Arabia), US FDA 4
Budesonide EDQM, SFDA (Saudi Arabia), US FDA 3
Etonogestrel EDQM, SFDA (Saudi Arabia), US FDA 3
Show all 30 molecules on file
Fluticasone Propionate EDQM, SFDA (Saudi Arabia), US FDA 3
Mometasone Furoate EDQM, US FDA 3
Norgestimate EDQM, US FDA 3
Beclomethasone Dipropionate EDQM 2
Bumetanide EDQM, US FDA 2
Formoterol EDQM, US FDA 2
Gestodene EDQM, SFDA (Saudi Arabia) 2
Indapamide EDQM, US FDA 2
Latanoprost EDQM, US FDA 2
Memantine SFDA (Saudi Arabia), US FDA 2
Salmeterol EDQM, SFDA (Saudi Arabia) 2
Tiotropium EDQM, US FDA 2
Zopiclone EDQM, US FDA 2
Bimatoprost US FDA 1
Brinzolamide US FDA 1
Dalfampridine US FDA 1
Deferiprone US FDA 1
Dofetilide US FDA 1
Estetrol US FDA 1
Idebenone US FDA 1

Also appears on these molecule pages

Abiraterone API Beclomethasone API Bimatoprost API Brinzolamide API Budesonide API Bumetanide API Dalfampridine API Deferiprone API Desogestrel API Dienogest API Dofetilide API Drospirenone API
Show 25 more molecule pages
Eplerenone API Estetrol API Ethinylestradiol API Etonogestrel API Fluticasone API Formoterol API Fulvestrant API Indapamide API Ivermectin API Latanoprost API Levonorgestrel API Loteprednol Etabonate API Memantine API Midodrine API Mometasone API Nitazoxanide API Norgestimate API Obeticholic Acid API Phentolamine API Progesterone API Salmeterol API Tiotropium API Travoprost API Ulipristal API Zopiclone API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 8 None

Questions about Industriale Chimica

Does Industriale Chimica hold a US DMF or a CEP?
Industriale Chimica holds 40 active US drug master files and 31 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 Industriale Chimica FDA-registered?
One site operated by Industriale Chimica 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 Industriale Chimica'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). 5 inspections are on file.
Where does Industriale Chimica manufacture?
2 registered sites are on record, in Italy (Saronno and Italy). Every site is listed on this page with the register it came from.
What does Industriale Chimica make?
30 molecules are on record against Industriale Chimica, including Abiraterone, Drospirenone, Desogestrel and Dienogest. Each links through to that molecule's full manufacturer list.
Where does Industriale Chimica 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

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

Comparable suppliers

Newchem shares 10 molecules Cipla shares 9 molecules Lupin shares 9 molecules Sterling shares 9 molecules MSN Laboratories shares 8 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