Suppliers / Minakem High Potent

Minakem High Potent

Belgium Updated 9 July 2026

Minakem High Potent is an API manufacturer based in Belgium. It holds 3 active US drug master files and 4 valid CEPs across a filed portfolio of 3 molecules. Its most recent recorded inspection, by US FDA, closed on 19 April 2023 as VAI.

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

Inspection history

  • 19 April 2023 VAI US FDA
  • 6 February 2020 VAI US FDA
  • 24 September 2015 NAI US FDA
  • 12 January 2012 VAI US FDA

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

Registered plants

Site FDA FEI
Mont-Saint-Guibert, Belgium Not on file
Corbais, Belgium Not on file
Mont-St-Guibert, Belgium Not on file
Belgium, Belgium 3002807801

What they file, and where

Molecule Regulators Docs
Vinblastine EDQM, US FDA 3
Vincristine EDQM, US FDA 2
Vinorelbine EDQM, US FDA 2

Also appears on these molecule pages

Vincristine API Vinorelbine API

Questions about Minakem High Potent

Does Minakem High Potent hold a US DMF or a CEP?
Minakem High Potent holds 3 active US drug master files and 4 valid CEPs. 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 Minakem High Potent FDA-registered?
One site operated by Minakem High Potent 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 Minakem High Potent's last inspection go?
The most recent inspection on record closed on 19 April 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Minakem High Potent manufacture?
4 registered sites are on record, in Belgium (Mont-saint-guibert, Corbais and Mont-st-guibert among others). Every site is listed on this page with the register it came from.
What does Minakem High Potent make?
3 molecules are on record against Minakem High Potent, including Vinblastine, Vincristine and Vinorelbine. Each links through to that molecule's full manufacturer list.

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 19 April 2023.

Comparable suppliers

Hubei Honch Pharmaceutical shares 2 molecules “Gedeon Richter” shares 1 molecule Hisun Pharmaceutical shares 1 molecule Jiangsu Hansoh Pharmaceutical Group shares 1 molecule Fine Chemicals Corporation (PTY) 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