Suppliers / Indena

Indena

Italy 2 duplicate records merged Updated 9 July 2026

Indena is an API manufacturer based in Italy. It holds 12 active US drug master files and 19 valid CEPs across a filed portfolio of 17 molecules. Its GMP standing is certified by ANSM (FR) and EMA. Its most recent recorded inspection, by US FDA, closed on 26 November 2021 as VAI.

12
active US DMFs
19
valid CEPs
6
registered plants 1 with an FDA FEI number
3
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
7 of 7 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

  • 26 November 2021 VAI US FDA
  • 10 May 2018 VAI US FDA
  • 29 July 2016 VAI US FDA
  • 4 April 2014 VAI US FDA
  • 31 March 2011 VAI US FDA
  • 30 March 2011 NAI US FDA
  • 16 October 2008 NAI US FDA

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

Registered plants

Site FDA FEI
TOURS, France Not on file
Tours, France Not on file
Milano, Italy Not on file
Milan, Italy Not on file
Settala, Italy Not on file
Italy, Italy 1000280888

What they file, and where

Molecule Regulators Docs
Colchicine EDQM, SFDA (Saudi Arabia), US FDA 5
Paclitaxel EDQM, SFDA (Saudi Arabia), US FDA 5
Docetaxel EDQM, US FDA 4
Thiocolchicoside Hydrate EDQM 3
Cabazitaxel US FDA 2
Cannabidiol EDQM, US FDA 2
Thiocolchicoside Crystallised From Ethanol EDQM 2
Thiotepa SFDA (Saudi Arabia), US FDA 2
Fresh Bilberry Fruit Dry Extract EDQM 1
Galantamine Hydrobromide EDQM 1
Show all 17 molecules on file
Milk Thistle Dry Extract EDQM 1
Reserpine US FDA 1
Resiniferatoxin US FDA 1
Saw Palmetto Extract EDQM 1
St. John'S Wort Dry Extract EDQM 1
Tirbanibulin US FDA 1
Voclosporin US FDA 1

Also appears on these molecule pages

Cabazitaxel contract manufacturing Cannabidiol contract manufacturing Colchicine contract manufacturing Docetaxel contract manufacturing Lenvatinib contract manufacturing Paclitaxel contract manufacturing Thiocolchicoside contract manufacturing Thiotepa API Voclosporin API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 3 None
ANSM (FR) None 20
EMA None 1

Questions about Indena

Does Indena hold a US DMF or a CEP?
Indena holds 12 active US drug master files and 19 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 Indena FDA-registered?
One site operated by Indena 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 Indena's last inspection go?
The most recent inspection on record closed on 26 November 2021 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 7 inspections are on file.
Where does Indena manufacture?
6 registered sites are on record, in France and Italy (Tours, Tours and Milano among others). Every site is listed on this page with the register it came from.
What does Indena make?
17 molecules are on record against Indena, including Colchicine, Paclitaxel, Docetaxel and Thiocolchicoside Hydrate. Each links through to that molecule's full manufacturer list.
Which regulators recognise Indena's GMP?
Current GMP certificates are on record from ANSM (FR) and 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

  • 1 active litigation matter is on record.
  • The most recent inspection outcome was VAI, on 26 November 2021.

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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