Suppliers / Medefil

Medefil

United States Updated 9 July 2026

Medefil is a finished-dose manufacturer based in United States. It appears in 13 regulatory filings across 1 regulator, without an active US DMF or CEP on file. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 21 April 2025 as VAI.

0
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
13
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 21 April 2025 VAI US FDA
  • 29 March 2018 VAI US FDA
  • 17 June 2016 VAI US FDA
  • 15 September 2014 VAI US FDA
  • 20 December 2012 VAI US FDA
  • 22 August 2012 NAI US FDA
  • 25 May 2012 VAI US FDA
  • 6 September 2011 OAI US FDA

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

Registered plants

Site FDA FEI
Glendale Heights, United States 3001677091

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 13 1

Questions about Medefil

Does Medefil hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Medefil. It does have 13 filings with one regulator, so it is registered, just not with the two strong registers buyers usually screen on.
Is Medefil FDA-registered?
One site operated by Medefil 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 Medefil's last inspection go?
The most recent inspection on record closed on 21 April 2025 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 Medefil manufacture?
1 registered site is on record, in United States (Glendale Heights). Every site is listed on this page with the register it came from.
Which regulators recognise Medefil'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

  • The most recent inspection outcome was VAI, on 21 April 2025.

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates