Suppliers / LUSOCHIMICA

LUSOCHIMICA

Italy Updated 9 July 2026

LUSOCHIMICA is an API manufacturer based in Italy. It holds 13 active US drug master files and 7 valid CEPs across a filed portfolio of 16 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 28 February 2025 as VAI.

13
active US DMFs
7
valid CEPs
5
registered plants 2 with an FDA FEI number
3
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 28 February 2025 VAI US FDA
  • 3 December 2021 VAI US FDA
  • 3 August 2018 VAI US FDA
  • 17 May 2018 VAI US FDA
  • 30 October 2015 VAI US FDA
  • 21 February 2014 NAI US FDA
  • 15 December 2011 VAI US FDA
  • 22 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
Casaletto Lodigiano, Italy Not on file
Lomagna, Italy Not on file
Pisa, Italy Not on file
Italy, Italy 3002807437
Italy, Italy 3002807514

What they file, and where

Molecule Regulators Docs
Albuterol EDQM, SFDA (Saudi Arabia), US FDA 3
Ipratropium EDQM, SFDA (Saudi Arabia), US FDA 3
Carteolol EDQM, US FDA 2
Glyburide EDQM, US FDA 2
Nicardipine US FDA 2
Nimodipine EDQM, US FDA 2
Zofenopril SFDA (Saudi Arabia) 2
Betaxolol US FDA 1
Dexketoprofen SFDA (Saudi Arabia) 1
Diltiazem US FDA 1
Show all 16 molecules on file
Formoterol US FDA 1
Formoterol Fumarate Dihydrate EDQM 1
Nebivolol EDQM 1
Nisoldipine US FDA 1
Orciprenaline US FDA 1
Silver Sulfadiazine US FDA 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 3 None
US FDA None 1

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Open risk flags

  • 1 active litigation matter is on record.
  • The most recent inspection outcome was VAI, on 28 February 2025.

Sources on this page

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