Suppliers / Biofer

Biofer

Italy 104 employees Updated 9 July 2026

Biofer is an API manufacturer based in Italy. It holds one active US drug master file across a filed portfolio of 3 molecules. Its most recent recorded inspection, by US FDA, closed on 30 September 2022 as VAI.

1
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
1
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
3 of 3 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 30 September 2022 VAI US FDA
  • 9 June 2017 VAI US FDA
  • 4 February 2014 VAI US FDA

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

Registered plants

Site FDA FEI
MEDOLLA, Italy Not on file
Italy, Italy 3005593220

What they file, and where

Molecule Regulators Docs
Ferric Hydroxide Polymaltose SFDA (Saudi Arabia) 1
Heparin Sodium US FDA 1
Hydrocortisone SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Heparin API Hydrocortisone API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 1 None

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Open risk flags

  • The most recent inspection outcome was VAI, on 30 September 2022.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability