Suppliers / Trifarma

Trifarma

Italy Updated 9 July 2026

Trifarma is an API manufacturer based in Italy. It holds 20 active US drug master files and one valid CEP across a filed portfolio of 18 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 27 September 2024 as VAI. Customs aggregates show $67K of exports covering 21 molecules to 3 destinations in 2025.

20
active US DMFs
1
valid CEPs
5
registered plants 2 with an FDA FEI number
2
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

  • 27 September 2024 VAI US FDA
  • 7 April 2023 VAI US FDA
  • 31 January 2020 VAI US FDA
  • 28 February 2019 VAI US FDA
  • 27 January 2017 VAI US FDA
  • 12 May 2016 VAI US FDA
  • 27 February 2015 VAI US FDA
  • 29 January 2014 OAI US FDA

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

Registered plants

Site FDA FEI
ROZZANO, Italy Not on file
Ceriano Laghetto, Italy Not on file
Italy, Italy 1000532829
Italy, Italy 3002807260
ATE, Peru Not on file

What they file, and where

Molecule Regulators Docs
Prochlorperazine US FDA 3
Fluphenazine US FDA 2
Minoxidil EDQM, US FDA 2
Clindamycin US FDA 1
Clocortolone US FDA 1
Epinastine US FDA 1
Foscarnet US FDA 1
Ganciclovir US FDA 1
Halobetasol Propionate US FDA 1
Hydrocortisone Valerate US FDA 1
Show all 18 molecules on file
Oxandrolone US FDA 1
Perphenazine US FDA 1
Testosterone US FDA 1
Testosterone Cypionate SFDA (Saudi Arabia) 1
Thioridazine US FDA 1
Tranylcypromine US FDA 1
Trifluoperazine US FDA 1
Zoledronic Acid US FDA 1

Also appears on these molecule pages

Clindamycin API Fluphenazine API Foscarnet API Ganciclovir API Halobetasol API Hydrocortisone API Minoxidil API Oxandrolone API Testosterone API Testosterone Cypionate API Zoledronic Acid API

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 2 None
US FDA None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $5K 2
2025 Not reported $67K 3
2024 Not reported $88K 4
2023 Not reported $455K 4

Export figures are customs aggregates. We do not publish the identity of any buyer.

Questions about Trifarma

Does Trifarma hold a US DMF or a CEP?
Trifarma holds 20 active US drug master files and 1 valid CEP. 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 Trifarma FDA-registered?
2 sites operated by Trifarma 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 Trifarma's last inspection go?
The most recent inspection on record closed on 27 September 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file, of which 1 closed as OAI.
Where does Trifarma manufacture?
5 registered sites are on record, in Italy and Peru (Rozzano, Ceriano Laghetto and Italy among others). Every site is listed on this page with the register it came from.
What does Trifarma make?
18 molecules are on record against Trifarma, including Prochlorperazine, Fluphenazine, Minoxidil and Clindamycin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Trifarma'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

  • 3 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 27 September 2024.

Comparable suppliers

Apitoria Pharma shares 3 molecules Curia shares 3 molecules Symbiotec Pharmalab shares 3 molecules Dr Reddy's Laboratories shares 2 molecules Lupin shares 2 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
Customs aggregates
Export values, molecule and destination counts