Suppliers / Safc

Safc

United States Updated 9 July 2026

Safc is an API manufacturer based in United States. 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 28 June 2024 as NAI.

2
active US DMFs
0
valid CEPs
2
registered plants 2 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 28 June 2024 NAI US FDA
  • 28 June 2024 NAI US FDA
  • 4 November 2016 NAI US FDA
  • 4 November 2016 NAI US FDA
  • 16 August 2012 NAI US FDA
  • 11 August 2011 NAI US FDA
  • 4 November 2009 NAI US FDA
  • 12 November 2008 VAI US FDA

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

Registered plants

Site FDA FEI
Madison, United States 2131129
Verona, United States 3008305047

What they file, and where

Molecule Regulators Docs
Paricalcitol SFDA (Saudi Arabia), US FDA 2
Sodium Arsenite US FDA 1

Also appears on these molecule pages

Paricalcitol API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 2

Questions about Safc

Does Safc hold a US DMF or a CEP?
Safc 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 Safc FDA-registered?
2 sites operated by Safc carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Safc's last inspection go?
The most recent inspection on record closed on 28 June 2024 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file.
Where does Safc manufacture?
2 registered sites are on record, in United States (Madison and Verona). Every site is listed on this page with the register it came from.
What does Safc make?
2 molecules are on record against Safc, including Paricalcitol and Sodium Arsenite. Each links through to that molecule's full manufacturer list.
Which regulators recognise Safc'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 28 June 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