Suppliers / Olon

Olon

Italy reconciled across 9 public records · 3 entities Updated 9 July 2026

Olon is an API and finished-dose manufacturer based in Italy. It holds 167 active US drug master files and 80 valid CEPs. Its filings concentrate with MINSA (CR), NCELS (KZ) and BOMRA (BW). Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 10 October 2025 as NAI.

167
active US DMFs
80
valid CEPs
19
registered plants 10 with an FDA FEI number
10
filings across 3 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
3 of 3 confirmed
Inspections
6 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 10 October 2025 NAI US FDA
  • 28 March 2025 VAI US FDA
  • 13 July 2023 VAI US FDA
  • 4 May 2023 VAI US FDA
  • 3 March 2023 VAI US FDA
  • 16 February 2023 VAI US FDA
  • 9 February 2023 VAI US FDA
  • 1 October 2021 VAI US FDA
  • 24 January 2020 VAI US FDA
  • 9 August 2019 VAI US FDA
  • 2 August 2019 NAI US FDA
  • 25 July 2019 VAI US FDA

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

Registered plants

Site FDA FEI
Raigad, India 3005983749
Rodano, Italy Not on file
SETTIMO TORINESE, Italy Not on file
DORNO, Italy Not on file
CASALETTO LODIGIANO, Italy Not on file
GARBAGNATE MILANESE, Italy Not on file

13 further sites are on record.

What they file, and where

Molecule Regulators Docs
Diclofenac EDQM, SFDA (Saudi Arabia), US FDA 6
Fluoxetine EDQM, US FDA 5
Hydroxyurea EDQM, SFDA (Saudi Arabia), US FDA 5
Lipoic Acid EDQM, SFDA (Saudi Arabia), US FDA 5
Tretinoin EDQM, SFDA (Saudi Arabia), US FDA 5
Valganciclovir SFDA (Saudi Arabia), US FDA 5
Acyclovir EDQM, US FDA 4
Fenofibrate EDQM, US FDA 4
Loperamide EDQM, US FDA 4
Miconazole EDQM, US FDA 4
Show all 40 molecules on file
Terbinafine EDQM, US FDA 4
Timolol EDQM, SFDA (Saudi Arabia), US FDA 4
Acamprosate EDQM, US FDA 3
Acitretin EDQM, US FDA 3
Bezafibrate EDQM, US FDA 3
Ciclopirox EDQM, US FDA 3
Isotretinoin EDQM, SFDA (Saudi Arabia), US FDA 3
Ketotifen EDQM, SFDA (Saudi Arabia), US FDA 3
Labetalol EDQM, SFDA (Saudi Arabia), US FDA 3
Minoxidil EDQM, SFDA (Saudi Arabia), US FDA 3
Quetiapine EDQM, US FDA 3
Rifampin EDQM, US FDA 3
Rifamycin US FDA 3
Rifaximin EDQM, US FDA 3
Tamoxifen EDQM, SFDA (Saudi Arabia), US FDA 3
Aceclidine US FDA 2
Adapalene EDQM, US FDA 2
Albuterol EDQM, US FDA 2
Amiloride EDQM, US FDA 2
Amitriptyline EDQM, US FDA 2
Amorolfine EDQM, SFDA (Saudi Arabia) 2
Aripiprazole EDQM, US FDA 2
Betahistine Dihydrochloride EDQM, SFDA (Saudi Arabia) 2
Betaxolol EDQM, US FDA 2
Bumetanide EDQM, US FDA 2
Bupropion US FDA 2
Choline Fenofibrate US FDA 2
Clidinium US FDA 2
Clofazimine US FDA 2
Clotrimazole EDQM, US FDA 2

Also appears on these molecule pages

Show 92 more molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 7 None
NCELS (KZ) 2 None
BOMRA (BW) 1 None
US FDA None 3

Questions about Olon

Does Olon hold a US DMF or a CEP?
Olon holds 167 active US drug master files and 80 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 Olon FDA-registered?
10 sites operated by Olon 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 Olon's last inspection go?
The most recent inspection on record closed on 10 October 2025 as NAI (No Action Indicated: nothing objectionable was found). 24 inspections are on file.
Where does Olon manufacture?
19 registered sites are on record, in India, Italy and United States (Raigad, Rodano and Settimo Torinese among others). Every site is listed on this page with the register it came from.
What does Olon make?
40 molecules are on record against Olon, including Diclofenac, Fluoxetine, Hydroxyurea and Lipoic Acid. Each links through to that molecule's full manufacturer list.
Which regulators recognise Olon'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

  • 6 active litigation matters are on record.
  • The most recent inspection outcome was NAI, on 10 October 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