Suppliers / Farmabios

Farmabios

Italy 158 employees Updated 9 July 2026

Farmabios is an API manufacturer based in Italy. It holds 51 active US drug master files. Its most recent recorded inspection, by US FDA, closed on 1 October 2021 as VAI.

51
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
4
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
6 of 6 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 1 October 2021 VAI US FDA
  • 20 September 2019 VAI US FDA
  • 26 May 2017 VAI US FDA
  • 23 October 2015 VAI US FDA
  • 13 December 2013 NAI US FDA
  • 23 September 2010 VAI US FDA

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

Registered plants

Site FDA FEI
GROPELLO CAIROLI, Italy Not on file
Italy, Italy 3002806965

What they file, and where

Molecule Regulators Docs
Triamcinolone US FDA 5
Budesonide SFDA (Saudi Arabia), US FDA 3
Mometasone Furoate SFDA (Saudi Arabia), US FDA 3
Beclomethasone Dipropionate SFDA (Saudi Arabia), US FDA 2
Betamethasone US FDA 2
Busulfan SFDA (Saudi Arabia), US FDA 2
Clobetasol Propionate SFDA (Saudi Arabia), US FDA 2
Dexamethasone US FDA 2
Fludrocortisone SFDA (Saudi Arabia), US FDA 2
Flunisolide US FDA 2
Show all 30 molecules on file
Fluocinolone Acetonide SFDA (Saudi Arabia), US FDA 2
Fluticasone Propionate SFDA (Saudi Arabia), US FDA 2
Fulvestrant SFDA (Saudi Arabia), US FDA 2
Loteprednol Etabonate US FDA 2
Melphalan SFDA (Saudi Arabia), US FDA 2
Prednisolone US FDA 2
Triamcinolone Acetonide SFDA (Saudi Arabia) 2
Betamethasone Dipropionate SFDA (Saudi Arabia) 1
Cannabidiol US FDA 1
Cefuroxime US FDA 1
Clocortolone US FDA 1
Cyproterone US FDA 1
Desonide US FDA 1
Desoximetasone US FDA 1
Difluprednate US FDA 1
Epoxide US FDA 1
Exemestane US FDA 1
Flumethasone US FDA 1
Flumethasone Pivalate SFDA (Saudi Arabia) 1
Fluocinonide US FDA 1

Also appears on these molecule pages

Beclomethasone API Betamethasone API Budesonide API Busulfan API Cannabidiol API Cefuroxime API Clobetasol API Cyproterone API Dexamethasone API Exemestane API Fluocinolone Acetonide API Fluorometholone API
Show 16 more molecule pages
Fluticasone API Formoterol API Fulvestrant API Hydrocortisone API Loteprednol Etabonate API Medroxyprogesterone API Megestrol API Melphalan API Methylprednisolone API Mometasone API Prednisolone API Testosterone Cypionate API Tirofiban API Triamcinolone API Triamcinolone Acetonide API Ursodeoxycholic Acid API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 4 None

Questions about Farmabios

Does Farmabios hold a US DMF or a CEP?
Farmabios holds 51 active US drug master files. 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 Farmabios FDA-registered?
One site operated by Farmabios 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 Farmabios's last inspection go?
The most recent inspection on record closed on 1 October 2021 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 6 inspections are on file.
Where does Farmabios manufacture?
2 registered sites are on record, in Italy (Gropello Cairoli and Italy). Every site is listed on this page with the register it came from.
What does Farmabios make?
30 molecules are on record against Farmabios, including Triamcinolone, Budesonide, Mometasone Furoate and Beclomethasone Dipropionate. Each links through to that molecule's full manufacturer list.
Where does Farmabios file?
Filings are on record with MINSA (CR), 4 in total.

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

  • 2 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 1 October 2021.

Comparable suppliers

Curia shares 15 molecules Henan Lihua Pharmaceutical shares 11 molecules Newchem shares 10 molecules Tianjin Tianyao Pharmaceuticals shares 9 molecules Symbiotec Pharmalab shares 8 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