Suppliers / Archimica

Archimica

Italy 103 employees Updated 9 July 2026

Archimica is an API manufacturer based in Italy. It holds 11 active US drug master files across a filed portfolio of 10 molecules. Its GMP standing is certified by ANSM (FR), EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 15 June 2023 as VAI.

11
active US DMFs
0
valid CEPs
5
registered plants 1 with an FDA FEI number
1
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
6 of 6 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

  • 15 June 2023 VAI US FDA
  • 13 September 2018 VAI US FDA
  • 21 July 2017 VAI US FDA
  • 28 April 2017 VAI US FDA
  • 25 September 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
BON ENCONTRE, France Not on file
TONNEINS, France Not on file
LODI, Italy Not on file
Lodi (LO), Italy Not on file
Italy, Italy 3002874947

What they file, and where

Molecule Regulators Docs
Hydroxyurea SFDA (Saudi Arabia), US FDA 3
Pirenzepine US FDA 2
Capecitabine US FDA 1
Cytarabine US FDA 1
Diacerein US FDA 1
Disopyramide US FDA 1
Hydralazine US FDA 1
Oxcarbazepine US FDA 1
Sucralfate US FDA 1
Sulfapyridine US FDA 1

Also appears on these molecule pages

Capecitabine API Cytarabine API Diacerein API Hydralazine API Hydroxyurea API Oxcarbazepine API Sucralfate API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 1 None
ANSM (FR) None 10
EMA None 2
US FDA None 1

Questions about Archimica

Does Archimica hold a US DMF or a CEP?
Archimica holds 11 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 Archimica FDA-registered?
One site operated by Archimica 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 Archimica's last inspection go?
The most recent inspection on record closed on 15 June 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 6 inspections are on file.
Where does Archimica manufacture?
5 registered sites are on record, in France and Italy (BON Encontre, Tonneins and Lodi among others). Every site is listed on this page with the register it came from.
What does Archimica make?
10 molecules are on record against Archimica, including Hydroxyurea, Pirenzepine, Capecitabine and Cytarabine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Archimica's GMP?
Current GMP certificates are on record from ANSM (FR), EMA 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

  • 1 active litigation matter is on record.
  • The most recent inspection outcome was VAI, on 15 June 2023.

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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