Suppliers / Carnegie Pharmaceuticals

Carnegie Pharmaceuticals

United States Updated 9 July 2026

Carnegie Pharmaceuticals is a finished-dose manufacturer based in United States. It appears in 12 regulatory filings across 1 regulator, without an active US DMF or CEP on file. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 31 October 2025 as NAI.

0
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
12
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
2 of 2 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 31 October 2025 NAI US FDA
  • 19 November 2021 NAI US FDA

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

Registered plants

Site FDA FEI
Delran, United States 3011603634

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 12 1

Questions about Carnegie Pharmaceuticals

Does Carnegie Pharmaceuticals hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Carnegie Pharmaceuticals. It does have 12 filings with one regulator, so it is registered, just not with the two strong registers buyers usually screen on.
Is Carnegie Pharmaceuticals FDA-registered?
One site operated by Carnegie 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 Carnegie Pharmaceuticals's last inspection go?
The most recent inspection on record closed on 31 October 2025 as NAI (No Action Indicated: nothing objectionable was found). 2 inspections are on file.
Where does Carnegie Pharmaceuticals manufacture?
1 registered site is on record, in United States (Delran). Every site is listed on this page with the register it came from.
Which regulators recognise Carnegie Pharmaceuticals'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 31 October 2025.

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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