Suppliers / Pfanstiehl

Pfanstiehl

United States 106 employees Updated 9 July 2026

Pfanstiehl is an API manufacturer based in United States. It holds 6 active US drug master files across a filed portfolio of 6 molecules. Its most recent recorded inspection, by US FDA, closed on 23 January 2023 as NAI.

6
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
7 of 7 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 23 January 2023 NAI US FDA
  • 5 October 2017 NAI US FDA
  • 9 February 2016 NAI US FDA
  • 19 June 2013 NAI US FDA
  • 11 February 2013 VAI US FDA
  • 17 August 2010 NAI US FDA
  • 8 May 2009 NAI US FDA

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

Registered plants

Site FDA FEI
Waukegan, United States 1410747

What they file, and where

Molecule Regulators Docs
Ammonium Lactate US FDA 1
Mannose US FDA 1
Methotrexate US FDA 1
Podofilox US FDA 1
Streptozocin US FDA 1
Tromethamine US FDA 1

Also appears on these molecule pages

Methotrexate API

Questions about Pfanstiehl

Does Pfanstiehl hold a US DMF or a CEP?
Pfanstiehl holds 6 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 Pfanstiehl FDA-registered?
One site operated by Pfanstiehl 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 Pfanstiehl's last inspection go?
The most recent inspection on record closed on 23 January 2023 as NAI (No Action Indicated: nothing objectionable was found). 7 inspections are on file.
Where does Pfanstiehl manufacture?
1 registered site is on record, in United States (Waukegan). Every site is listed on this page with the register it came from.
What does Pfanstiehl make?
6 molecules are on record against Pfanstiehl, including Ammonium Lactate, Mannose, Methotrexate and Podofilox. 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

  • 2 active litigation matters are on record.
  • The most recent inspection outcome was NAI, on 23 January 2023.

Comparable suppliers

MSN Laboratories shares 1 molecule Alembic Pharmaceuticals shares 1 molecule Shilpa Pharma Lifesciences shares 1 molecule Fermion shares 1 molecule Excella Gmbh 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