Suppliers / Siegfried Grafton

Siegfried Grafton

United States Updated 9 July 2026

The public registers hold a second record for Siegfried Grafton. The fuller profile, with 94 active US DMFs and 40 valid CEPs, is at Siegfried. Figures on this page cover only this record.

Siegfried Grafton is an API manufacturer based in United States. It holds 9 active US drug master files and 3 valid CEPs across a filed portfolio of 9 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 14 August 2024 as NAI.

9
active US DMFs
3
valid CEPs
2
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
6 of 6 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 14 August 2024 NAI US FDA
  • 15 July 2016 VAI US FDA
  • 4 April 2013 VAI US FDA
  • 10 June 2011 VAI US FDA
  • 20 September 2010 NAI US FDA
  • 14 December 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
Grafton, United States Not on file
Grafton, United States 3001655239

What they file, and where

Molecule Regulators Docs
Fentanyl EDQM, US FDA 3
Brimonidine EDQM, US FDA 2
Benzatropine US FDA 1
Flavin Mononucleotide US FDA 1
Fluoxymesterone US FDA 1
Methylnaltrexone US FDA 1
Nepafenac US FDA 1
Oxandrolone US FDA 1
Travoprost US FDA 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Siegfried Grafton

Does Siegfried Grafton hold a US DMF or a CEP?
Siegfried Grafton holds 9 active US drug master files and 3 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 Siegfried Grafton FDA-registered?
One site operated by Siegfried Grafton 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 Siegfried Grafton's last inspection go?
The most recent inspection on record closed on 14 August 2024 as NAI (No Action Indicated: nothing objectionable was found). 6 inspections are on file.
Where does Siegfried Grafton manufacture?
2 registered sites are on record, in United States (Grafton among others). Every site is listed on this page with the register it came from.
What does Siegfried Grafton make?
9 molecules are on record against Siegfried Grafton, including Fentanyl, Brimonidine, Benzatropine and Flavin Mononucleotide. Each links through to that molecule's full manufacturer list.
Which regulators recognise Siegfried Grafton'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 NAI, on 14 August 2024.

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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