Suppliers / Eisai Manufacturing

Eisai Manufacturing

United Kingdom 630 employees 2 duplicate records merged Updated 9 July 2026

Eisai Manufacturing is a finished-dose manufacturer based in United Kingdom. It appears in 81 regulatory filings across 10 regulators, without an active US DMF or CEP on file. Its filings concentrate with ANVISA (Brazil), US FDA and EDE (AE). Its GMP standing is certified by MHRA (UK), ANVISA (Brazil) and US FDA, among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 9 April 2024 as VAI.

0
active US DMFs
0
valid CEPs
10
registered plants 5 with an FDA FEI number
81
filings across 10 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
5 of 5 confirmed
Inspections
8 of 8 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 9 April 2024 VAI US FDA
  • 27 October 2023 VAI US FDA
  • 18 November 2022 VAI US FDA
  • 21 January 2022 VAI US FDA
  • 1 February 2019 VAI US FDA
  • 21 December 2018 VAI US FDA
  • 29 November 2018 VAI US FDA
  • 15 September 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
Hatfield, United Arab Emirates Not on file
São Paulo, Brazil Not on file
SAO PAULO, Brazil Not on file
HATFIELD, United Kingdom Not on file
United Kingdom, United Kingdom 3008356774
Japan, Japan 3002806886

4 further sites are on record.

Filings and GMP by regulator

Regulator Filings GMP certificates
ANVISA (Brazil) 18 3
US FDA 15 2
EDE (AE) 13 None
SAHPRA (ZA) 11 None
CDSCO (India) 9 None
NPRA (MY) 5 None
MHRA (UK) None 4
MFDS (Korea) None 2
EMA None 1

Questions about Eisai Manufacturing

Does Eisai Manufacturing hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Eisai Manufacturing. It does have 81 filings with 10 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Eisai Manufacturing FDA-registered?
5 sites operated by Eisai Manufacturing 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 Eisai Manufacturing's last inspection go?
The most recent inspection on record closed on 9 April 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Eisai Manufacturing manufacture?
10 registered sites are on record, in United Arab Emirates, Brazil, United Kingdom and Japan (Hatfield, São Paulo and SAO Paulo among others). Every site is listed on this page with the register it came from.
Which regulators recognise Eisai Manufacturing's GMP?
Current GMP certificates are on record from MHRA (UK), ANVISA (Brazil), US FDA, MFDS (Korea) and EMA. 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 9 April 2024.

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Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

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