Suppliers / Norgine Healthcare

Norgine Healthcare

United Kingdom 37 employees Updated 9 July 2026

Norgine Healthcare is a finished-dose manufacturer based in United Kingdom. It appears in 480 regulatory filings across 18 regulators, without an active US DMF or CEP on file. Its filings concentrate with EMA, MHRA (UK) and AIFA (IT). Its GMP standing is certified by MHRA (UK), EAEU_EEC and US FDA, among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 20 June 2025 as VAI.

0
active US DMFs
0
valid CEPs
6
registered plants 1 with an FDA FEI number
480
filings across 18 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
2 of 2 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

  • 20 June 2025 VAI US FDA
  • 16 August 2019 VAI US FDA

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

Registered plants

Site FDA FEI
Hengoed, United Arab Emirates Not on file
Luzern, Switzerland Not on file
NEWPORT, United Kingdom Not on file
HENGOED, United Kingdom Not on file
United Kingdom, United Kingdom 3005202761
Amsterdam, Netherlands Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA 121 1
MHRA (UK) 108 5
AIFA (IT) 78 None
SWISSMEDIC (CH) 36 None
AEMPS (ES) 27 None
FAMHP (BE) 24 None
EAEU_EEC None 1
US FDA None 1

Questions about Norgine Healthcare

Does Norgine Healthcare hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Norgine Healthcare. It does have 480 filings with 18 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Norgine Healthcare FDA-registered?
One site operated by Norgine Healthcare 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 Norgine Healthcare's last inspection go?
The most recent inspection on record closed on 20 June 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 2 inspections are on file.
Where does Norgine Healthcare manufacture?
6 registered sites are on record, in United Arab Emirates, Switzerland, United Kingdom and Netherlands (Hengoed, Luzern and Newport among others). Every site is listed on this page with the register it came from.
Which regulators recognise Norgine Healthcare's GMP?
Current GMP certificates are on record from MHRA (UK), EEC (Eurasian Economic Union), US FDA 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 20 June 2025.

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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