Suppliers / Regis Technologies

Regis Technologies

United States Updated 9 July 2026

Regis Technologies is an API manufacturer based in United States. It holds 4 active US drug master files across a filed portfolio of 3 molecules. Its most recent recorded inspection, by US FDA, closed on 16 November 2022 as VAI.

4
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

  • 16 November 2022 VAI US FDA
  • 23 April 2019 NAI US FDA
  • 15 August 2016 NAI US FDA
  • 17 December 2013 NAI US FDA
  • 30 March 2012 NAI US FDA
  • 8 March 2011 VAI US FDA
  • 8 May 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
Morton Grove, United States 1416120

What they file, and where

Molecule Regulators Docs
Dalfampridine SFDA (Saudi Arabia), US FDA 3
Acetazolamide US FDA 2
Bromfenc SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Acetazolamide API Dalfampridine API

Questions about Regis Technologies

Does Regis Technologies hold a US DMF or a CEP?
Regis Technologies holds 4 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 Regis Technologies FDA-registered?
One site operated by Regis Technologies 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 Regis Technologies's last inspection go?
The most recent inspection on record closed on 16 November 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 7 inspections are on file.
Where does Regis Technologies manufacture?
1 registered site is on record, in United States (Morton Grove). Every site is listed on this page with the register it came from.
What does Regis Technologies make?
3 molecules are on record against Regis Technologies, including Dalfampridine, Acetazolamide and Bromfenc. 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

  • The most recent inspection outcome was VAI, on 16 November 2022.

Comparable suppliers

Apitoria Pharma shares 1 molecule Micro Labs shares 1 molecule Gland Pharma shares 1 molecule Industriale Chimica shares 1 molecule CTX Lifesciences 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