Suppliers / LUSOCHIMICA

LUSOCHIMICA

Italy Updated 9 July 2026

LUSOCHIMICA is an API and finished-dose 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
Lomagna, Italy Not on file
Casaletto Lodigiano, 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

Albuterol API Avanafil finished dose Dexketoprofen API Diltiazem API Formoterol API Glibenclamide API Glyburide API Ipratropium API Nebivolol API Nicardipine API Nimodipine API Salbutamol API
Show 1 more molecule pages
Silver Sulfadiazine API

Filings and GMP by regulator

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

Questions about LUSOCHIMICA

Does LUSOCHIMICA hold a US DMF or a CEP?
LUSOCHIMICA holds 13 active US drug master files and 7 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 LUSOCHIMICA FDA-registered?
2 sites operated by LUSOCHIMICA 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 LUSOCHIMICA's last inspection go?
The most recent inspection on record closed on 28 February 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does LUSOCHIMICA manufacture?
5 registered sites are on record, in Italy (Lomagna, Casaletto Lodigiano and Pisa among others). Every site is listed on this page with the register it came from.
What does LUSOCHIMICA make?
16 molecules are on record against LUSOCHIMICA, including Albuterol, Ipratropium, Carteolol and Glyburide. Each links through to that molecule's full manufacturer list.
Which regulators recognise LUSOCHIMICA'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.

Comparing suppliers?

Choose your molecules and target markets. LUSOCHIMICA comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Open risk flags

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

Comparable suppliers

Cambrex Profarmaco Milano shares 5 molecules Olon shares 4 molecules Vamsi Labs shares 4 molecules Melody Healthcare shares 4 molecules Cipla shares 3 molecules

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