Suppliers / Adare Pharmaceuticals

Adare Pharmaceuticals

Italy 8 employees Updated 9 July 2026

Adare Pharmaceuticals is an API and finished-dose manufacturer based in Italy. It holds 2 active US drug master files across a filed portfolio of 2 molecules. Its filings concentrate with MPA (SE), ARCSA (EC) and US FDA. Its GMP standing is certified by ANSM (FR), EMA and ANVISA (Brazil), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 25 February 2025 as VAI.

2
active US DMFs
0
valid CEPs
7
registered plants 2 with an FDA FEI number
12
filings across 7 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
8 of 8 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

  • 25 February 2025 VAI US FDA
  • 28 October 2022 VAI US FDA
  • 25 January 2019 NAI US FDA
  • 11 July 2018 NAI US FDA
  • 13 April 2018 VAI US FDA
  • 19 May 2017 NAI US FDA
  • 24 February 2017 VAI US FDA
  • 30 May 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
HOUDAN, France Not on file
PESSANO CON BORNAGO (MI), Italy Not on file
Pessano Con Bornago, Italy Not on file
San Giuliano Milanese, Italy Not on file
Pessano Con Bornago, Italy 1000573478
VANDALIA, United States Not on file

1 further sites are on record.

What they file, and where

Molecule Regulators Docs
Acetaminophen US FDA 1
Ibuprofen US FDA 1

Also appears on these molecule pages

Acetaminophen API Cyclobenzaprine finished dose Ibuprofen API Paracetamol API

Filings and GMP by regulator

Regulator Filings GMP certificates
MPA (SE) 2 None
ARCSA (EC) 2 None
US FDA 2 1
NMPA (CN) 2 None
DPM (TN) 2 None
INVIMA (CO) 1 None
ANSM (FR) None 11
EMA None 7
ANVISA (Brazil) None 1

Questions about Adare Pharmaceuticals

Does Adare Pharmaceuticals hold a US DMF or a CEP?
Adare Pharmaceuticals holds 2 active US drug master files. 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 Adare Pharmaceuticals FDA-registered?
2 sites operated by Adare Pharmaceuticals 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 Adare Pharmaceuticals's last inspection go?
The most recent inspection on record closed on 25 February 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Adare Pharmaceuticals manufacture?
7 registered sites are on record, in France, Italy and United States (Houdan, Pessano CON Bornago (mi) and Pessano Con Bornago among others). Every site is listed on this page with the register it came from.
What does Adare Pharmaceuticals make?
2 molecules are on record against Adare Pharmaceuticals, including Acetaminophen and Ibuprofen. Each links through to that molecule's full manufacturer list.
Which regulators recognise Adare Pharmaceuticals's GMP?
Current GMP certificates are on record from ANSM (FR), EMA, ANVISA (Brazil) 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

  • 6 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 25 February 2025.

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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