Suppliers / Amneal Pharmaceuticals of New York

Amneal Pharmaceuticals of New York

United States Updated 9 July 2026

Amneal Pharmaceuticals of New York is a finished-dose manufacturer based in United States. It appears in 109 regulatory filings across 2 regulators, without an active US DMF or CEP on file. Its filings concentrate with US FDA and EDE (AE). Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 7 June 2023 as NAI.

0
active US DMFs
0
valid CEPs
3
registered plants 2 with an FDA FEI number
109
filings across 2 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

  • 7 June 2023 NAI US FDA
  • 3 February 2020 NAI US FDA
  • 20 December 2019 NAI US FDA
  • 18 April 2019 NAI US FDA
  • 18 March 2019 VAI US FDA
  • 30 January 2019 VAI US FDA
  • 10 July 2018 NAI US FDA
  • 24 May 2017 VAI US FDA

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

Registered plants

Site FDA FEI
Brookhaven, United Arab Emirates Not on file
Brookhaven, United States 3005263655
Hauppauge, United States 2434153

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 106 1
EDE (AE) 3 None

Questions about Amneal Pharmaceuticals of New York

Does Amneal Pharmaceuticals of New York hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Amneal Pharmaceuticals of New York. It does have 109 filings with 2 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Amneal Pharmaceuticals of New York FDA-registered?
2 sites operated by Amneal Pharmaceuticals of New York 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 Amneal Pharmaceuticals of New York's last inspection go?
The most recent inspection on record closed on 7 June 2023 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file.
Where does Amneal Pharmaceuticals of New York manufacture?
3 registered sites are on record, in United Arab Emirates and United States (Brookhaven and Hauppauge among others). Every site is listed on this page with the register it came from.
Which regulators recognise Amneal Pharmaceuticals of New York'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 7 June 2023.

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates