Suppliers / Padagis Us

Padagis Us

United States Updated 9 July 2026

Padagis Us is a finished-dose manufacturer based in United States. It holds one active US drug master file. Its filings concentrate with US FDA and DMP (NO). Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 6 September 2024 as VAI.

1
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
59
filings across 2 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

  • 6 September 2024 VAI US FDA
  • 31 January 2024 NAI US FDA
  • 5 May 2023 NAI US FDA
  • 18 February 2022 VAI US FDA
  • 23 October 2019 NAI US FDA
  • 7 July 2017 VAI US FDA
  • 6 November 2013 NAI US FDA
  • 6 February 2013 NAI US FDA

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

Registered plants

Site FDA FEI
Minneapolis, United States 2127022

What they file, and where

Molecule Regulators Docs
Conjugated Estrogens US FDA 1

Also appears on these molecule pages

Clotrimazole finished dose Efinaconazole finished dose Flavoxate finished dose Hydromorphone finished dose Lenalidomide finished dose Loteprednol Etabonate finished dose Tavaborole finished dose Tretinoin finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 57 1
DMP (NO) 2 None

Questions about Padagis Us

Does Padagis Us hold a US DMF or a CEP?
Padagis Us holds 1 active US drug master file. 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 Padagis Us FDA-registered?
One site operated by Padagis Us 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 Padagis Us's last inspection go?
The most recent inspection on record closed on 6 September 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Padagis Us manufacture?
1 registered site is on record, in United States (Minneapolis). Every site is listed on this page with the register it came from.
What does Padagis Us make?
1 molecule is on record against Padagis Us, including Conjugated Estrogens. Each links through to that molecule's full manufacturer list.
Which regulators recognise Padagis Us'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

  • 16 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 6 September 2024.

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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