Suppliers / Erregierre

Erregierre

Italy 106 employees 2 duplicate records merged Updated 9 July 2026

Erregierre is an API manufacturer based in Italy. It holds 24 active US drug master files and 17 valid CEPs. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 14 March 2025 as NAI.

24
active US DMFs
17
valid CEPs
4
registered plants 2 with an FDA FEI number
3
filings across 1 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

  • 14 March 2025 NAI US FDA
  • 23 September 2022 VAI US FDA
  • 26 July 2019 NAI US FDA
  • 14 June 2018 VAI US FDA
  • 12 February 2016 NAI US FDA
  • 16 November 2012 NAI US FDA
  • 16 November 2012 NAI US FDA
  • 20 May 2010 NAI US FDA

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

Registered plants

Site FDA FEI
SOVERE, Italy Not on file
San Paolo D'Argon, Italy Not on file
Italy, Italy 3002806924
Italy, Italy 3003780995

What they file, and where

Molecule Regulators Docs
Mesalazine EDQM, US FDA 4
Ciclopirox EDQM, US FDA 3
Rivastigmine EDQM, US FDA 3
Bisacodyl EDQM, US FDA 2
Butenafine SFDA (Saudi Arabia), US FDA 2
Clotrimazole EDQM, US FDA 2
Fluoxetine EDQM, US FDA 2
Raloxifene EDQM, US FDA 2
Ambroxol EDQM 1
Amisulpride EDQM 1
Show all 30 molecules on file
Aripiprazole US FDA 1
Bifonazole EDQM 1
Bupropion US FDA 1
Carprofen For Veterinary Use EDQM 1
Ciclopirox Olamine EDQM 1
Gabapentin EDQM 1
Gepirone US FDA 1
Ingavirin US FDA 1
Isoconazole Nitrate EDQM 1
Miconazole US FDA 1
Milrinone SFDA (Saudi Arabia) 1
Nabumetone US FDA 1
Naftifine US FDA 1
Nisoldipine US FDA 1
Propafenone US FDA 1
Sulconazole US FDA 1
Tiaprofenic Acid EDQM 1
Ticlopidine EDQM 1
Tioconazole US FDA 1
Tolterodine US FDA 1

Also appears on these molecule pages

Show 13 more molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 3 None
US FDA None 1

Questions about Erregierre

Does Erregierre hold a US DMF or a CEP?
Erregierre holds 24 active US drug master files and 17 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 Erregierre FDA-registered?
2 sites operated by Erregierre 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 Erregierre's last inspection go?
The most recent inspection on record closed on 14 March 2025 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file.
Where does Erregierre manufacture?
4 registered sites are on record, in Italy (Sovere, San Paolo D'argon and Italy among others). Every site is listed on this page with the register it came from.
What does Erregierre make?
30 molecules are on record against Erregierre, including Mesalazine, Ciclopirox, Rivastigmine and Bisacodyl. Each links through to that molecule's full manufacturer list.
Which regulators recognise Erregierre's GMP?
Current GMP certificates are on record from 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

  • The most recent inspection outcome was NAI, on 14 March 2025.

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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