Suppliers / Marcus Research Laboratory

Marcus Research Laboratory

United States Updated 9 July 2026

Marcus Research Laboratory is an API manufacturer based in United States. It holds one active US drug master file. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 12 July 2024 as VAI.

1
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
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 12 July 2024 VAI US FDA
  • 2 September 2022 OAI US FDA
  • 14 May 2021 OAI US FDA
  • 6 December 2019 OAI US FDA
  • 6 April 2017 VAI US FDA
  • 20 June 2014 VAI US FDA
  • 6 July 2012 VAI US FDA
  • 14 March 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
Saint Louis, United States 1950348

What they file, and where

Molecule Regulators Docs
Povidone-Iodine US FDA 1

Also appears on these molecule pages

Povidone-Iodine API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Marcus Research Laboratory

Does Marcus Research Laboratory hold a US DMF or a CEP?
Marcus Research Laboratory 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 Marcus Research Laboratory FDA-registered?
One site operated by Marcus Research Laboratory 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 Marcus Research Laboratory's last inspection go?
The most recent inspection on record closed on 12 July 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file, of which 4 closed as OAI.
Where does Marcus Research Laboratory manufacture?
1 registered site is on record, in United States (Saint Louis). Every site is listed on this page with the register it came from.
What does Marcus Research Laboratory make?
1 molecule is on record against Marcus Research Laboratory, including Povidone-Iodine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Marcus Research Laboratory'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 12 July 2024.

Comparable suppliers

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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