Suppliers / Olon

Olon

Italy Updated 9 July 2026

Olon is an API and finished-dose manufacturer based in Italy. It holds 162 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 28 March 2025 as VAI.

162
active US DMFs
80
valid CEPs
12
registered plants 3 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
3 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 28 March 2025 VAI US FDA
  • 13 July 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

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

Registered plants

Site FDA FEI
CAPUA, Italy Not on file
Rodano, Italy Not on file
GARBAGNATE MILANESE, Italy Not on file
SETTIMO TORINESE, Italy Not on file
MULAZZANO, Italy Not on file
GARESSIO, Italy Not on file

6 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
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
Hydroxyurea EDQM, US FDA 4
Loperamide EDQM, US FDA 4
Miconazole EDQM, US FDA 4
Show all 30 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

Also appears on these molecule pages

Abacavir API Acyclovir API Adapalene API Amitriptyline API Azacitidine API Betahistine API Bicalutamide API Cabergoline finished dose Cefdinir API Ciclopirox API Clotrimazole API Daptomycin API
Show 27 more molecule pages
Diclofenac API Escitalopram API Fenofibrate API Fluoxetine API Gabapentin API Gliclazide API Haloperidol API Isotretinoin API Lansoprazole API Loperamide API Memantine API Miconazole API Minoxidil API Moxifloxacin API Oxybutynin API Piroxicam API Pramipexole API Quetiapine API Rifampicin API Ritonavir API Salbutamol API Tamoxifen API Terbinafine API Timolol API Tolvaptan API Tretinoin API Umeclidinium API

Filings and GMP by regulator

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

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Open risk flags

  • 6 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 28 March 2025.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates