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

Questions about Biofer

Does Biofer hold a US DMF or a CEP?
Biofer holds 1 active US drug master file. 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 Biofer FDA-registered?
One site operated by Biofer 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 Biofer's last inspection go?
The most recent inspection on record closed on 30 September 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does Biofer manufacture?
2 registered sites are on record, in Italy (Medolla and Italy). Every site is listed on this page with the register it came from.
What does Biofer make?
3 molecules are on record against Biofer, including Ferric Hydroxide Polymaltose, Heparin Sodium and Hydrocortisone. Each links through to that molecule's full manufacturer list.
Where does Biofer file?
Filings are on record with MINSA (CR), 1 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

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

Comparable suppliers

Gland Pharma shares 1 molecule Sandoz shares 1 molecule Leo Pharma shares 1 molecule Dongying Tiandong Pharmaceutical shares 1 molecule Hebei Changshan Biochemical Pharmaceutical shares 1 molecule

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