Suppliers / Siegfried USA

Siegfried USA

United States SQG0.F Updated 9 July 2026

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

Siegfried USA is an API manufacturer based in United States. It holds 18 active US drug master files across a filed portfolio of 14 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 17 September 2025 as NAI.

18
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

  • 17 September 2025 NAI US FDA
  • 27 September 2023 VAI US FDA
  • 19 December 2018 VAI US FDA
  • 24 March 2016 NAI US FDA
  • 15 May 2014 NAI US FDA
  • 26 March 2013 VAI US FDA
  • 6 February 2013 VAI US FDA
  • 30 March 2011 NAI US FDA

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

Registered plants

Site FDA FEI
Pennsville, United States 2227314

What they file, and where

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Siegfried USA

Does Siegfried USA hold a US DMF or a CEP?
Siegfried USA holds 18 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 Siegfried USA FDA-registered?
One site operated by Siegfried USA 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 USA's last inspection go?
The most recent inspection on record closed on 17 September 2025 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file.
Where does Siegfried USA manufacture?
1 registered site is on record, in United States (Pennsville). Every site is listed on this page with the register it came from.
What does Siegfried USA make?
14 molecules are on record against Siegfried USA, including Dextroamphetamine, Amphetamine, Buprenorphine and Amobarbital. Each links through to that molecule's full manufacturer list.
Which regulators recognise Siegfried USA'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

  • 100 active litigation matters are on record.
  • The most recent inspection outcome was NAI, on 17 September 2025.

Comparable suppliers

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