Suppliers / Organon Pharma (Uk)

Organon Pharma (Uk)

United Kingdom Updated 9 July 2026

Organon Pharma (Uk) is a finished-dose manufacturer based in United Kingdom. It appears in 498 regulatory filings across 10 regulators, without an active US DMF or CEP on file. Its filings concentrate with MHRA (UK), BPOM (ID) and EMA. Its GMP standing is certified by BPOM (ID), ANVISA (Brazil) and MHRA (UK), among 7 authorities. Its most recent recorded inspection, by US FDA, closed on 13 June 2025 as VAI.

0
active US DMFs
0
valid CEPs
7
registered plants 1 with an FDA FEI number
498
filings across 10 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 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

  • 13 June 2025 VAI US FDA
  • 14 June 2018 VAI US FDA
  • 6 February 2015 NAI US FDA
  • 22 March 2013 VAI US FDA
  • 9 March 2010 NAI US FDA

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

Registered plants

Site FDA FEI
Cramlington, United Arab Emirates Not on file
Mexico D.F., Colombia Not on file
United Kingdom, United Kingdom 3002807653
CRAMLINGTON, United Kingdom Not on file
CRAMLINGTON, United Kingdom Not on file
-, Indonesia Not on file

1 further sites are on record.

Filings and GMP by regulator

Regulator Filings GMP certificates
MHRA (UK) 239 2
BPOM (ID) 153 22
EMA 34 None
NPRA (MY) 23 None
SFDA (Saudi Arabia) 13 None
ARCSA (EC) 12 None
ANVISA (Brazil) None 3
MFDS (Korea) None 2
US FDA None 1
EAEU_EEC None 1
NAFDAC (NG) None 1

Questions about Organon Pharma (Uk)

Does Organon Pharma (Uk) hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Organon Pharma (Uk). It does have 498 filings with 10 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Organon Pharma (Uk) FDA-registered?
One site operated by Organon Pharma (Uk) 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 Organon Pharma (Uk)'s last inspection go?
The most recent inspection on record closed on 13 June 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Organon Pharma (Uk) manufacture?
7 registered sites are on record, in United Arab Emirates, Colombia, United Kingdom and Indonesia (Cramlington, Mexico D.f. and United Kingdom among others). Every site is listed on this page with the register it came from.
Which regulators recognise Organon Pharma (Uk)'s GMP?
Current GMP certificates are on record from BPOM (ID), ANVISA (Brazil), MHRA (UK), MFDS (Korea), US FDA and 2 more. 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 13 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