Suppliers / Ocular Therapeutix

Ocular Therapeutix

United States 333 employees Updated 9 July 2026

Ocular Therapeutix is a finished-dose manufacturer based in United States. It appears in 2 regulatory filings across 2 regulators, without an active US DMF or CEP on file. Its filings concentrate with US FDA and EMA. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 9 November 2023 as NAI.

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

  • 9 November 2023 NAI US FDA
  • 11 February 2016 VAI US FDA

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

Registered plants

Site FDA FEI
Bedford, United States 3008477155

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 1 1
EMA 1 None

Questions about Ocular Therapeutix

Does Ocular Therapeutix hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Ocular Therapeutix. It does have 2 filings with 2 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Ocular Therapeutix FDA-registered?
One site operated by Ocular Therapeutix 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 Ocular Therapeutix's last inspection go?
The most recent inspection on record closed on 9 November 2023 as NAI (No Action Indicated: nothing objectionable was found). 2 inspections are on file.
Where does Ocular Therapeutix manufacture?
1 registered site is on record, in United States (Bedford). Every site is listed on this page with the register it came from.
Which regulators recognise Ocular Therapeutix'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 9 November 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