Suppliers / Antares Pharma

Antares Pharma

United States 56 employees Updated 9 July 2026

Antares Pharma is a finished-dose manufacturer based in United States. It appears in 20 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 16 January 2025 as NAI.

0
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
20
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 16 January 2025 NAI US FDA

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

Registered plants

Site FDA FEI
Hopkins, United States 2182861

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 20 1

Questions about Antares Pharma

Does Antares Pharma hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Antares Pharma. It does have 20 filings with one regulator, so it is registered, just not with the two strong registers buyers usually screen on.
Is Antares Pharma FDA-registered?
One site operated by Antares Pharma 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 Antares Pharma's last inspection go?
The most recent inspection on record closed on 16 January 2025 as NAI (No Action Indicated: nothing objectionable was found). 1 inspection is on file.
Where does Antares Pharma manufacture?
1 registered site is on record, in United States (Hopkins). Every site is listed on this page with the register it came from.
Which regulators recognise Antares Pharma'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 16 January 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