Suppliers / Menadiona Sl

Menadiona Sl

Spain Updated 9 July 2026

Menadiona Sl is an API manufacturer based in Spain. It holds 2 active US drug master files across a filed portfolio of 2 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 10 July 2024 as VAI.

2
active US DMFs
0
valid CEPs
1
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
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 10 July 2024 VAI US FDA
  • 10 June 2022 VAI US FDA
  • 11 July 2018 VAI US FDA
  • 29 April 2016 VAI US FDA
  • 1 October 2009 VAI US FDA

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

Registered plants

Site FDA FEI
Spain, Spain 1000242648

What they file, and where

Molecule Regulators Docs
Chlorthalidone US FDA 1
Clomifene US FDA 1

Also appears on these molecule pages

Chlorthalidone API Clomifene API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Menadiona Sl

Does Menadiona Sl hold a US DMF or a CEP?
Menadiona Sl holds 2 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 Menadiona Sl FDA-registered?
One site operated by Menadiona Sl 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 Menadiona Sl's last inspection go?
The most recent inspection on record closed on 10 July 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Menadiona Sl manufacture?
1 registered site is on record, in Spain (Spain). Every site is listed on this page with the register it came from.
What does Menadiona Sl make?
2 molecules are on record against Menadiona Sl, including Chlorthalidone and Clomifene. Each links through to that molecule's full manufacturer list.
Which regulators recognise Menadiona Sl'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 10 July 2024.

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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
EudraGMDP and national regulators
GMP certificates