Suppliers / COSMA

COSMA

Italy 2 duplicate records merged Updated 9 July 2026

COSMA is an API manufacturer based in Italy. It holds 34 active US drug master files and 4 valid CEPs across a filed portfolio of 18 molecules. Its most recent recorded inspection, by US FDA, closed on 17 June 2022 as VAI.

34
active US DMFs
4
valid CEPs
2
registered plants 1 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
4 of 4 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 17 June 2022 VAI US FDA
  • 15 January 2016 VAI US FDA
  • 22 March 2013 VAI US FDA
  • 10 July 2009 VAI US FDA

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

Registered plants

Site FDA FEI
Italy, Italy 3002806754
Ciserano, Italy Not on file

What they file, and where

Molecule Regulators Docs
Torasemide EDQM, US FDA 5
Hydroxyzine US FDA 4
Propranolol SFDA (Saudi Arabia), US FDA 4
Amisulpride EDQM, US FDA 3
Gliclazide SFDA (Saudi Arabia), US FDA 3
Ketoprofen EDQM, US FDA 3
Cetirizine US FDA 2
Diclofenac US FDA 2
Labetalol US FDA 2
Levomilnacipran US FDA 2
Show all 18 molecules on file
Metoclopramide US FDA 2
Milnacipran US FDA 2
Oxaprozin US FDA 2
Pyrantel US FDA 2
Ranolazine US FDA 2
Cetirizine Dihydrochloride SFDA (Saudi Arabia) 1
Hydroxyzine Dihydrochloride SFDA (Saudi Arabia) 1
Rifaximin EDQM 1

Also appears on these molecule pages

Amisulpride API Cetirizine API Diclofenac API Gliclazide API Hydroxyzine API Ketoprofen API Labetalol API Levomilnacipran API Metoclopramide API Milnacipran API Propranolol API Pyrantel API
Show 3 more molecule pages
Ranolazine API Rifaximin API Torasemide API

Questions about COSMA

Does COSMA hold a US DMF or a CEP?
COSMA holds 34 active US drug master files and 4 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 COSMA FDA-registered?
One site operated by COSMA 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 COSMA's last inspection go?
The most recent inspection on record closed on 17 June 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does COSMA manufacture?
2 registered sites are on record, in Italy (Italy and Ciserano). Every site is listed on this page with the register it came from.
What does COSMA make?
18 molecules are on record against COSMA, including Torasemide, Hydroxyzine, Propranolol and Amisulpride. Each links through to that molecule's full manufacturer list.

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 17 June 2022.

Comparable suppliers

Ipca Laboratories shares 6 molecules Hetero shares 5 molecules Macleods Pharmaceuticals shares 5 molecules Solara Active Pharma Sciences shares 5 molecules Raks Pharma shares 5 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