Suppliers / Chemi

Chemi

Italy 257 employees 2 duplicate records merged Updated 9 July 2026

Chemi is an API and finished-dose manufacturer based in Italy. It holds 9 active US drug master files and 6 valid CEPs across a filed portfolio of 10 molecules. Its filings concentrate with AIFA (IT), INFARMED (PT) and FAMHP (BE). Its GMP standing is certified by MFDS (Korea) and US FDA. Its most recent recorded inspection, by US FDA, closed on 26 January 2024 as VAI.

9
active US DMFs
6
valid CEPs
4
registered plants 2 with an FDA FEI number
153
filings across 8 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 26 January 2024 VAI US FDA
  • 9 March 2023 VAI US FDA
  • 20 September 2019 VAI US FDA
  • 25 May 2018 VAI US FDA
  • 12 October 2017 VAI US FDA
  • 12 May 2016 VAI US FDA
  • 3 April 2014 NAI US FDA
  • 28 March 2014 VAI US FDA

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

Registered plants

Site FDA FEI
Patrica, Italy Not on file
Cinisello Balsamo, Italy Not on file
Italy, Italy 3002806667
Italy, Italy 3000326763

What they file, and where

Molecule Regulators Docs
Mesalazine EDQM, SFDA (Saudi Arabia), US FDA 6
Bupropion US FDA 2
Leuprolide EDQM, US FDA 2
Aminoimidazole Carboxamide US FDA 1
Benserazide EDQM 1
Diflunisal US FDA 1
Flunarizine Dihydrochloride EDQM 1
Givinostat US FDA 1
Octreotide US FDA 1
Paroxetine EDQM 1

Also appears on these molecule pages

Bendamustine finished dose Benserazide API Bupropion API Enoxaparin finished dose Flunarizine API Ibandronate finished dose Ibandronic Acid finished dose Leuprolide API Mesalamine API Mesalazine API Octreotide API Paroxetine API

Filings and GMP by regulator

Regulator Filings GMP certificates
AIFA (IT) 97 None
INFARMED (PT) 12 None
FAMHP (BE) 10 None
MPA (SE) 9 None
EMA 8 None
NPRA (MY) 7 None
MFDS (Korea) None 2
US FDA None 1

Questions about Chemi

Does Chemi hold a US DMF or a CEP?
Chemi holds 9 active US drug master files and 6 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 Chemi FDA-registered?
2 sites operated by Chemi 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 Chemi's last inspection go?
The most recent inspection on record closed on 26 January 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Chemi manufacture?
4 registered sites are on record, in Italy (Patrica, Cinisello Balsamo and Italy among others). Every site is listed on this page with the register it came from.
What does Chemi make?
10 molecules are on record against Chemi, including Mesalazine, Bupropion, Leuprolide and Aminoimidazole Carboxamide. Each links through to that molecule's full manufacturer list.
Which regulators recognise Chemi's GMP?
Current GMP certificates are on record from MFDS (Korea) and US FDA. 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

  • 5 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 26 January 2024.

Comparable suppliers

Apitoria Pharma shares 4 molecules Zydus Lifesciences shares 4 molecules Ipca Laboratories shares 4 molecules Alembic Pharmaceuticals shares 3 molecules Matrix Pharmacorp shares 3 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
EudraGMDP and national regulators
GMP certificates