Suppliers / Seqirus

Seqirus

United States Updated 9 July 2026

Seqirus is a finished-dose manufacturer based in United States. It appears in 316 regulatory filings across 13 regulators, without an active US DMF or CEP on file. Its filings concentrate with MEDSAFE (NZ), Health Canada and EMA. Its GMP standing is certified by ANVISA (Brazil), MHRA (UK) and US FDA. Its most recent recorded inspection, by US FDA, closed on 5 June 2025 as VAI.

0
active US DMFs
0
valid CEPs
3
registered plants 1 with an FDA FEI number
316
filings across 13 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 5 June 2025 VAI US FDA
  • 9 June 2022 VAI US FDA
  • 18 June 2018 VAI US FDA
  • 17 May 2016 VAI US FDA
  • 21 November 2013 NAI US FDA

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

Registered plants

Site FDA FEI
MAIDENHEAD, United Kingdom Not on file
NORTH CAROLINA, United States Not on file
Holly Springs, United States 3007867647

Filings and GMP by regulator

Regulator Filings GMP certificates
MEDSAFE (NZ) 168 None
Health Canada 39 None
EMA 31 None
FAMHP (BE) 20 None
MPA (SE) 16 None
AIFA (IT) 15 None
ANVISA (Brazil) None 2
MHRA (UK) None 2
US FDA None 1

Questions about Seqirus

Does Seqirus hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Seqirus. It does have 316 filings with 13 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Seqirus FDA-registered?
One site operated by Seqirus 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 Seqirus's last inspection go?
The most recent inspection on record closed on 5 June 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Seqirus manufacture?
3 registered sites are on record, in United Kingdom and United States (Maidenhead, North Carolina and Holly Springs). Every site is listed on this page with the register it came from.
Which regulators recognise Seqirus's GMP?
Current GMP certificates are on record from ANVISA (Brazil), MHRA (UK) and 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 VAI, on 5 June 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