Suppliers / ANI Pharmaceuticals

ANI Pharmaceuticals

United States 678 employees Updated 9 July 2026

ANI Pharmaceuticals is a finished-dose manufacturer based in United States. It appears in 223 regulatory filings across 2 regulators, without an active US DMF or CEP on file. Its filings concentrate with US FDA and DMP (NO). Its most recent recorded inspection, by US FDA, closed on 18 November 2022 as VAI.

0
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
223
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

  • 18 November 2022 VAI US FDA
  • 12 April 2019 NAI US FDA
  • 28 July 2016 VAI US FDA
  • 27 September 2013 VAI US FDA
  • 6 January 2012 VAI US FDA
  • 16 September 2011 NAI US FDA
  • 15 September 2011 NAI US FDA
  • 29 January 2010 VAI US FDA

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

Registered plants

Site FDA FEI
Baudette, United States 2111358

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 221 None
DMP (NO) 2 None

Questions about ANI Pharmaceuticals

Does ANI Pharmaceuticals hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for ANI Pharmaceuticals. It does have 223 filings with 2 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is ANI Pharmaceuticals FDA-registered?
One site operated by ANI Pharmaceuticals 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 ANI Pharmaceuticals's last inspection go?
The most recent inspection on record closed on 18 November 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does ANI Pharmaceuticals manufacture?
1 registered site is on record, in United States (Baudette). Every site is listed on this page with the register it came from.
Where does ANI Pharmaceuticals file?
Filings are on record with US FDA and DMP (NO), 223 in total.

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 18 November 2022.

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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