Suppliers / Recordati Industria Chimica e Farmaceutica

Recordati Industria Chimica e Farmaceutica

Italy RER1.F Updated 9 July 2026

Recordati Industria Chimica e Farmaceutica is an API and finished-dose manufacturer based in Italy. It holds 16 active US drug master files and 8 valid CEPs across a filed portfolio of 17 molecules. Its filings concentrate with AIFA (IT), URPL (PL) and EMA. Its GMP standing is certified by EMA. Its most recent recorded inspection, by US FDA, closed on 30 September 2022 as VAI.

16
active US DMFs
8
valid CEPs
4
registered plants 1 with an FDA FEI number
477
filings across 15 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 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

  • 30 September 2022 VAI US FDA
  • 22 June 2019 VAI US FDA
  • 7 June 2018 NAI US FDA
  • 1 July 2016 VAI US FDA
  • 23 July 2010 VAI US FDA

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

Registered plants

Site FDA FEI
APRILIA, Italy Not on file
Milano, Italy Not on file
Milan, Italy Not on file
Italy, Italy 3002807989

What they file, and where

Molecule Regulators Docs
Acyclovir EDQM, SFDA (Saudi Arabia), US FDA 4
Cysteamine SFDA (Saudi Arabia), US FDA 3
Dimenhydrinate EDQM, SFDA (Saudi Arabia), US FDA 3
Diphenhydramine EDQM, US FDA 3
Dobutamine EDQM, SFDA (Saudi Arabia), US FDA 3
Phenytoin US FDA 3
Dopamine SFDA (Saudi Arabia), US FDA 2
Ketorolac EDQM, US FDA 2
Carglumic Acid US FDA 1
Cysteamine Bitartrate SFDA (Saudi Arabia) 1
Show all 17 molecules on file
Fenticonazole EDQM 1
Flavoxate US FDA 1
Lercanidipine SFDA (Saudi Arabia) 1
Mebeverine EDQM 1
Papaverine US FDA 1
Tribenoside EDQM 1
Verapamil US FDA 1

Also appears on these molecule pages

Acyclovir API Carglumic Acid API Cysteamine API Dimenhydrinate API Diphenhydramine API Dobutamine API Felodipine finished dose Flavoxate API Icosapent Ethyl finished dose Ketorolac Tromethamine API Lercanidipine API Leuprolide finished dose
Show 4 more molecule pages
Lovastatin finished dose Mepivacaine finished dose Phenytoin API Verapamil API

Filings and GMP by regulator

Regulator Filings GMP certificates
AIFA (IT) 208 None
URPL (PL) 161 None
EMA 62 2
ANSM (FR) 12 None
FAMHP (BE) 9 None
MINSA (CR) 4 None

Questions about Recordati Industria Chimica e Farmaceutica

Does Recordati Industria Chimica e Farmaceutica hold a US DMF or a CEP?
Recordati Industria Chimica e Farmaceutica holds 16 active US drug master files and 8 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 Recordati Industria Chimica e Farmaceutica FDA-registered?
One site operated by Recordati Industria Chimica e Farmaceutica 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 Recordati Industria Chimica e Farmaceutica's last inspection go?
The most recent inspection on record closed on 30 September 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Recordati Industria Chimica e Farmaceutica manufacture?
4 registered sites are on record, in Italy (Aprilia, Milano and Milan among others). Every site is listed on this page with the register it came from.
What does Recordati Industria Chimica e Farmaceutica make?
17 molecules are on record against Recordati Industria Chimica e Farmaceutica, including Acyclovir, Cysteamine, Dimenhydrinate and Diphenhydramine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Recordati Industria Chimica e Farmaceutica'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 30 September 2022.

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Sources on this page

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